Special EuroTier 2022 promotion. All visitors to our booth are eligible for 10% off an AgraVision™ Pro reader and 1 free AgraStrip^® Pro WATEX^® test kit. Stop by and speak to one of our mycotoxin experts for details. 

AgraStrip^® Pro WATEX^® test kits are lateral flow devices for the rapid, on-site detection of mycotoxins in a variety of agricultural commodities. With the newly developed AgraVision™ Pro reader, the system features an intuitive walk-away operation to allow for simple testing for several different mycotoxins in less than 10 minutes while helping to eliminate common handling errors. Join us for a demo on: 

• Tuesday, November 15 at 15:30 

• Wednesday, November 16 at 14:30 

• Thursday, November 17 at 12:00 

We’ll see you in hall 22, booth A25! 

With limits of detection as low as 0.1%, AgraStrip^® Pro GMO test strips are among the most sensitive available. AgraStrip^® Pro RUR Bulk Grain, which features a market-leading LOD of 0.05% in its high-sensitive method, quantifies CP4 EPSPS in soy, while AgraStrip^® Pro LL Bulk Grain quantifies PAT in soy, corn and canola. 

Kurt Brunner, Managing Director: “We at Romer Labs have always prided ourselves on knowing what our customers need and our ability to deliver it. We are now bringing to our GMO customers the benefits of the AgraStrip^® Pro system that our mycotoxin customers already enjoy: speed, sensitivity and a degree of simplicity in operation that can only be called intuitive.” 

Learn more about AgraStrip^® Pro GMO.

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
+43 2782 803 0 | joshua.davis@dsm.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, microbiology, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. We operate six accredited, full-service laboratories on three continents. Romer Labs is a company of DSM.
 

With a limit of detection of 15 ppb, the AgraStrip^® Pro T-2/HT-2 WATEX^® test kit is one of the most sensitive rapid solutions on the market. Paired with the AgraVision^™ Pro reader, the system allows for the independent and simultaneous testing of up to four samples in an intuitive, walk-away procedure, while the Romer Labs Data Manager automatically collects test results, enabling further analysis, storage, and transfer to a LIMS.

Kurt Brunner, Managing Director: “With the AgraStrip^® Pro WATEX^® system, we set out to reconceptualize the on-site testing for mycotoxins in terms of speed, convenience and the elimination of handling errors. Now, with the advent of our AgraStrip^® Pro T-2/HT-2 WATEX^® test kit, our innovative approach extends to all of the six most commonly regulated mycotoxins, including total aflatoxin, deoxynivalenol, total fumonisin, zearalenone, and ochratoxin.”

Learn more about the AgraStrip^® Pro WATEX^® system.

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
+43 2782 803 0 | joshua.davis@dsm.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, microbiology, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. We operate six accredited, full-service laboratories on three continents. Romer Labs is a company of DSM.
 

In this webinar, the Romer Labs experts investigate ISO 17034-certified reference materials and their ability to fulfill the stringent requirements that ISO 17025-accredited labs have. ISO 17034-certified reference materials exhibit exceptionally high degrees of metrological traceability and feature precise data about homogeneity, stability and uncertainty.

You will also learn:

• What ISO is and what it does
• The reason for the ISO 17034 standard
• The criteria that certified reference material producers have to fulfill, such as characterization, stability, and traceability
• How ISO 17034 reference materials can help analytical labs, especially those with an ISO 17025 accreditation

Watch the webinar now!

• An updated list of global priority food allergens based on prevalence, potency and severity of allergic reaction 
• Potentially new food allergens 
• Thresholds of allergen content in final products 
• The potential future of precautionary allergen labelling (PAL)

The AgraStrip^® Pro WATEX^® test system provides for the rapid and simple on-site quantification of mycotoxins in a variety of commodities. Paired with the AgraVision™ Pro reader, the system allows for the independent and simultaneous testing of up to four samples in an intuitive, walk-away procedure. Zearalenone is just one of five analytes currently covered by the AgraStrip^® Pro WATEX^® system: solutions for total aflatoxin, deoxynivalenol, total fumonisin and ochratoxin A are also available.

Kurt Brunner, Managing Director: “We are delighted that our AgraStrip^® Pro Zearalenone WATEX^® solution has received FGIS approval. It is a good indicator of the robustness and precision of the entire system, including our strip tests and the AgraVision™ Pro reader. We look forward to announcing FGIS approvals for our other mycotoxin rapid tests soon.”

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
+43 2782 803 0 | joshua.davis@dsm.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, microbiology, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. We operate six accredited, full-service laboratories on three continents. Romer Labs is part of DSM.

What kind of mycotoxin tester are you? How does that influence what you expect of a rapid testing solution?

While those testing for mycotoxins at raw material reception tend to look for solutions that offer a quick time-to-result, others performing quality control for highly refined products may emphasize the need for precision and scalability. 

In this issue of Spot On, we look closely at four common mycotoxin testing roles and the unique challenges they address using rapid testing solutions. Also: two of our scientists give some practical tips on sample preparation to help improve your results.

In this issue:

• The 4 types of mycotoxin testers and what they expect from a rapid solution
• The effects of particle size on mycotoxin testing results
• The interplay of particle size and sample size

Biopure™ ISO 17034 (Certified) Reference Materials meet these needs. Both ISO 17034 Certified Reference Materials and ISO 17034 Reference Materials (not certified) undergo the same rigorous process of characterization according to ISO 17034. All come with a certificate that states the assigned value and the uncertainty and provides information about the production process and product characterization. The purity of all raw materials is assessed by an accredited quantitative NMR method, and all final products are tested for homogeneity and long-term as well as short-term stability.

Kurt Brunner, Managing Director: “We at Romer Labs operate our own ISO 17025-accredited laboratories, so we know from our own experience the challenges that confront analytical labs seeking to maintain high standards in a demanding environment. With our Biopure™ ISO 17034 (Certified) Reference Materials, we go a long way in providing labs with quality that they can rely on.”

To learn more about Biopure™ ISO 17034 (Certified) Reference Materials, visit romerlabs.com.

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
+43 2782 803 0 | joshua.davis@dsm.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, microbiology, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. We operate six accredited, full-service laboratories on three continents. Romer Labs is part of DSM.

• What is the most effective method of establishing allergen thresholds?
• Under which circumstances should a validation be conducted?
• Is there a specific type of test most suited for verification testing?

Claviceps fungi (most prominently Claviceps purpurea) produce several separate compounds that are grouped together as ergot alkaloids; the 12 regulated compounds include ergotamine, ergometrine and α-ergosine. The molds affect a wide variety of grass species and small grains, with rye being the most common agricultural host.

Producers of raw materials, food and feed need to protect both animals and humans from the consumption of goods contaminated with ergot alkaloids. They are known to cause dermal necrosis and affect production (weight gain, eggs, milk). They also cause gangrenous syndromes, neuropathological changes, digestive disorders and reduced weight gain.

Examples of the new threshold are 0.5 g/kg of sclerotia in unprocessed rye and 150 ppb ergot alkaloids in milling products of barley, wheat, spelt and oats.

• PEAL: Regulations and recent developments. How is the new PEAL different and what does it mean for businesses and consumers?
• Impacts of non-compliant product labelling. Product recalls, economic impacts and actions taken for non-compliant products.
• Allergen management in practice: Nestlé. How allergen management strategies are implemented in a food manufacturing setting and the key success drivers for effective implementation.
• Solutions and developments in allergen detection. Trends and types of tests and analysis for effective food allergen management.

Food matrices themselves bring their own degree of complexity: thanks to the sheer multiplicity of ingredients and food preparation methods, there is a virtually infinite number of matrices, each with the potential to complicate testing by LFD or laboratory methods such as ELISA or PCR.

In this webinar, Romer Labs Technical Services Director Christy Swoboda teams up with BRCGS Technical Manager Barry Meikle to tackle some of the issues that make allergen and gluten testing so challenging. They explain why there is no such thing as a one-size-fits-all approach to allergen and gluten testing and discuss the value of mastering a variety of tools to fit your unique needs.

You will also learn about:

• Cross-contamination and allergen control
• Product specifications
• Internal audits
• The complexities of testing hydrolyzed and fermented products for gluten
• The need for specific validations for complex matrices
• The toolbox approach to allergen and gluten testing

You will learn about:

• Mycotoxin survey data concerning maize and wheat in South Africa
• Trends in mycotoxin prevalence over time
• Mycotoxin detection strategies
• The importance of proper sampling

• What is protein error technology?
• How does this technology compare to current total protein methods?
• What are the benefits around total protein detection using protein error technology?
• A brief introduction to RapidChek™ Total Protein

You will discover:

• Best practices when developing your allergen management plan
• The different testing methods available
• Finding the right balance between methodologies and meet compliance

In this webinar, hygiene expert Markus Dürrschmid breaks down the basics of hygiene in food production with an overview of microbial environmental monitoring.

Join us and learn more about:

• Requirements and standards associated with microbial environmental monitoring
• Basic concepts surrounding contamination and hygiene
• Some guidelines and tools for environmental sampling
• Practical examples A Q&A session based on your questions will conclude the webinar

In this webinar, Nora Kogelnik, product manager at Romer Labs, discusses the AgraStrip^® Pro WATEX^® system, the new system for the reliable, on-site quantification of mycotoxins.

Topics include:

• The basics of the AgraStrip^® Pro WATEX^® system
• Details about the individual test strips for total aflatoxin, deoxynivalenol, total fumonisin and zearalenone
• The AgraVision™ Pro reader
• Who the AgraStrip^® Pro WATEX^® system is designed for
• How it works

We’ll also explore the latest on-site rapid test methods for mycotoxin detection.

What you’ll learn

• Upcoming mycotoxin threats in livestock feed across the globe
• Rapid, on-site testing solutions for mycotoxins
• The dangers posed by the presence of multiple mycotoxins and emerging mycotoxins
• The key components of an effective mycotoxin risk management program

Choose Your Edition

Choose the webinar edition that best matches the geographical region you're interested in.

Designed with the needs of those who test in mind, the AgraStrip^® Pro WATEX^® system makes mycotoxin testing more efficient, simplifying workflow and allowing for optimal time management. The entire test procedure is completed in 10 minutes, with the assay itself taking only four minutes.

With the newly developed AgraVision™ Pro reader, the system allows for the independent and simultaneous testing of up to four samples in an intuitive, walk-away procedure. The reader automates timing, temperature and flow, eliminating the potential for handling errors. Its robust design and integrated incubator ensure that it can secure precise, quantitative results even in the toughest of conditions. Data management and reporting is made simpler with blockchain-enabled test strips and easy connectivity to PCs and a printer.

All AgraStrip^® Pro WATEX^® mycotoxin kits share a common, water-based extraction and dilution procedure, eliminating the need for organic solvents that can harm both the user and the environment.

Eva Wanzenböck, Managing Director, Romer Labs: “We began our quest to reimagine our AgraStrip^® system by asking those who test for mycotoxins on-site one question: What is it that you need from a mycotoxin test kit? The result is the AgraStrip^® Pro WATEX^® system. With this new solution, we once again unite our drive for usability with our obsession for analytical precision. AgraStrip^® Pro WATEX^® proves that the reliable quantification of mycotoxins doesn’t have to come at the cost of user-friendliness.”

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
+43 2782 803 0 | joshua.davis@romerlabs.com
 

In this issue: 

• 7 things you need to know about mycotoxin reference materials
• Mycotoxin reference materials: the math behind the measurements
• Certified reference materials – why they’re important

Enjoy this issue of Spot On!

When performing a validation of measurement procedures, analysts compare the value generated by each measurement of the QCM to the certified value stated in its certificate. Informally, some describe this comparison in a qualitative manner with statements such as, “the measured value agrees well with the certified value of the quality control material.” However, a quantitative approach can compare these two values mathematically, thereby excluding bias and providing a tool to keep track of the results over time.

In this article, Martina Bellasio guides you through the basics of calculating uncertainty measurement and how to quantify it in QCMs.

The acquisition of Erber Group’s Biomin further strengthens DSM’s expertise and reputation as a leading provider of animal health and nutrition solutions for farm productivity and sustainability, with an emphasis on emissions reduction, feed consumption efficiency, and better use of water and land. It is therefore very much aligned with DSM’s focus to make animal farming more sustainable from both an ecological and economical perspective. Romer Labs also complements DSM’s human nutrition and health offering to customers in the food & beverages market segments.

DSM – Bright Science. Brighter Living.™
Royal DSM is a global, purpose-led, science-based company active in Nutrition, Health and Sustainable Living. DSM’s purpose is to create brighter lives for all. DSM addresses with its products and solutions some of the world’s biggest challenges while simultaneously creating economic, environmental and societal value for all its stakeholders – customers, employees, shareholders, and society at large. DSM delivers innovative solutions for human nutrition, animal nutrition, personal care and aroma, medical devices, green products and applications, and new mobility and connectivity. DSM and its associated companies deliver annual net sales of about €10 billion with approximately 23,000 employees. The company was founded in 1902 and is listed on Euronext Amsterdam. More information can be found at www.dsm.com.

Forward-looking statements
This press release may contain forward-looking statements with respect to DSM’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law. The English language version of the press release is leading.

For more information: 
DSM Media Relations
Lieke de Jong
tel. +31 (0) 45 5782420
e-mail media.contacts@dsm.com

DSM Investor Relations 
Dave Huizing
tel. +31 (0) 45 5782864
e-mail investor.relations@dsm.com 

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

Download the DSM press release.

View all product information as well as your own prices and customized deals. See your entire order history and check the status of your current orders. Download invoices, certificates and other documents at the click of a mouse. 

All the information you need, whenever and wherever.

The ISO 17025 accreditation applies to Romer Labs AgraQuant^® ELISA test kits in the Singapore laboratory and includes five commonly occurring food allergens (fish, milk, peanut, sesame and soy) as well as gluten. The only treatment for food allergies is complete avoidance of foods containing the allergen or allergens in question. The same is true with gluten; only a gluten-free diet can protect the consumer from the effects of celiac disease.

Yong Wee Liau, Managing Director of Romer Labs Singapore: “Food producers looking to make sure that their products are allergen-free need to know that the analytical labs they rely on are methodologically sound. This accreditation confirms the precision and accuracy of our ELISA methods at the Romer Labs APAC Solutions Centre in Singapore. Now, our APAC customers can enjoy even faster turnaround times for ISO 17025-accredited testing for food allergens and gluten; our normal turnaround time is 5 workdays, but we offer an express option of 3 workdays.”

To celebrate the new accreditation, Romer Labs is offering customers one free allergen or gluten test with a purchase of three until 30 September 2020. For more information, please visit www.romerlabs.com/en/allergen-testing-lab-sg.  

For inquiries, please contact:
Joshua Davis
Communications Manager
T: +43 2782 803 0
E: joshua.davis@romerlabs.com

All AgraStrip^® WATEX mycotoxin kits share the same water-based extraction procedure, making it simple to test for 5 mycotoxins from the same extraction in an environmentally friendly way.

Ochratoxin A belongs to a group of mycotoxins produced by molds such as Aspergillus ochraceous and Penicillium verrucosum; they are subject to regulations in food and animal feed in several jurisdictions throughout the world. Found in raw commodities such as grains, as well as coffee, soy and wine, ochratoxin A has been classified as a Group 2B potential human carcinogen. Animal feed ingredients contaminated with ochratoxin A are particularly dangerous to poultry and swine.

The AgraStrip^® Ochratoxin A WATEX^® kit saves time and effort. Preparing the buffer and sample is easy to learn. Getting quantitative results is just as simple with the AgraVision^™ reader.

Eva Wanzenböck, Managing Director, Romer Labs: “All of us in the Romer Labs team are proud to welcome this new ochratoxin A test kit to our AgraStrip^® line of rapid solutions. The FGIS approval simply underscores what we already knew: it is possible to design a kit for a field-testing environment that is eco-friendly, fast, reliable and sensitive.”

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
Telephone: +43 2782 803 0
E-mail: joshua.davis@romerlabs.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

The acquired businesses have combined sales of €330m and an Adjusted EBITDA margin above 20% for the twelve months to the end of March 2020, with a high single-digit organic sales growth rate over the past 5 years. The acquisition will be debt financed, with committed bridge financing in place. DSM continues to benefit from a strong balance sheet and remains committed to maintaining a strong investment grade credit profile.

With state-of-the-art research and manufacturing facilities and approximately 1,200 employees around the world, the acquisition of Erber Group is a unique strategic opportunity that provides revenue-enhancing synergies from the combined offering, global customer base, and complementary geographic strengths. Austrian-based Erber Group offers DSM the opportunity to enter the mycotoxin risk management market as the world leader and extends the company’s position as one of the top suppliers in the rapidly growing animal gut performance management market.

Mycotoxins occur as a result of natural fungus contaminants in animal feed and threaten the health of both animals and humans. In addition to increasing the risk of illness, mycotoxins also reduce the nutritional value of feed. Biomin’s patented and proprietary technology provides the most scientifically advanced mycotoxin protection available. Biomin is also a major producer of phytogenic and probiotic feed alternatives to antibiotics, which complements and strengthens DSM’s position in the rapidly growing global eubiotics market for improving animal gut health.

Romer Labs is at the forefront of diagnostic technology with innovative testing solutions for the analysis of mycotoxins in feed and food, food allergens and pathogens as well as veterinary drug residues, with accredited full-service labs in Austria, UK, USA and Singapore. DSM’s extensive global network of food and beverage customers as well as feed customers stand to benefit from Romer Labs’ expertise and the combined group’s data-based quality assurance offering.

The acquisition of Erber Group further strengthens DSM’s expertise and reputation as a leading provider of animal health and nutrition solutions for farm productivity and sustainability, with an emphasis on emissions reduction, feed consumption efficiency, and better use of water and land.

Geraldine Matchett and Dimitri de Vreeze, Co-CEOs of DSM, said: “These are great businesses with strong and sustained track records of profitable growth and attractive margins. Biomin and Romer Labs will help strengthen and accelerate the growth of our specialty animal nutrition and health offering, including our big data and diagnostic capabilities, and it is exciting to be entrusted to take these family-founded businesses forward. It was immediately clear to us that the people at Erber Group share our purpose-led mission and will make a wonderful addition to DSM”.

Dr. Erich Erber, Founder and President of Erber Group, commented: “In DSM, I recognize the mutual values of sustainable stewardship that are so important to us. The world must reduce farming’s environmental impact at the same time as increasing protein production to feed 10 billion people by 2050. To do that, we have to make sure protein is produced sustainably, using renewable ingredients as much as possible, while protecting the well-being of animals. DSM is the perfect home for our businesses, as Biomin and Romer Labs will be able to use their new scale to intensify our joint contribution to a more sustainable world’s food supply”.

The transaction, which remains subject to customary conditions, is expected to close in Q4 2020.

More details can be found on the DSM website.

In this webinar, two experts from Romer Labs investigate how multi-mycotoxin clean-up columns can lead to higher recovery of target mycotoxins and results that are more precise; in short, clean-up columns can help to sharpen your view of multi-mycotoxin contamination. A discussion of the regulatory landscape in the Asia/Pacific region provides further context to this important topic.
 

• Integrated mycotoxin management with MyToolBox
• Drought and increased aflatoxin levels
• Flooding and fumonisins

Enjoy this issue of Spot On.

Dr. Michael Walker, Head of the Office of Government Chemist, and Adrian Rogers, Senior Research Scientist with Romer Labs UK discussed how reference materials are key to assure the quality, reliability, and comparability of analytical results obtained with different analytical methods. 

Topics of the webinar:

• Why there is a need for reference materials
• What is the best approach to producing reference materials
• How reference materials are validated
• Where can reference materials be applied

Click here to watch the webinar!

BIOMIN and Romer Labs joined together to host an exclusive webinar featuring an in-depth discussion on upcoming mycotoxin threats to poultry, swine, ruminants and aquaculture worldwide based on recent BIOMIN Mycotoxin Survey results. 

They also explored the latest methods for mycotoxin detection and the growing body of knowledge around less well known (‘emerging’) mycotoxins.

New this year! We're featuring 2 editions of the webinar, one for EMEA and APAC, and one for the Americas and EMEA.

RapidChek^® Campylobacter was developed in collaboration with a large poultry processor looking for an efficient way to comply with new USDA regulations that require the industry to implement qualitative testing for the pathogen using enrichment-based procedures. RapidChek^® Campylobacter detects the three regulated species, C. jejuni, C. coli, and C. lari, in carcass rinses, raw ground chicken and turkey carcass swabs.

Julie Sundgaard, Managing Director, Romer Labs North America: “We have been hearing from our customers in the poultry sector that they need a rapid, reliable test for Campylobacter that doesn’t need specialized and expensive equipment to comply with new regulations. With the RapidChek^® Campylobacter test kit, we provide them with the solution they have been looking for. The procedure is simple: an all-in-one aerobic enrichment media requires no additional supplements for preparation, and the whole test can be learned with minimal training. We know that resource management is an issue for poultry processors; this is why we made sure that our kit can be stored at room temperature and has a long shelf life. Third-party certifications are pending.” 

To learn more about RapidChek^® Campylobacter, visit romerlabs.com/en/campy.

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
Telephone: +43 2782 803 0
E-mail: joshua.davis@romerlabs.com

About Romer Labs^®
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.
 

The APAC Solutions Centre features new facilities for food allergen testing. Romer Labs can now serve the region with analytical services that cover gluten and the broadest range of allergenic analytes on the market. The Centre also brings augmented mycotoxin testing methods with screening services such as Multi-Mycotoxin Analysis 50+, which gives specific information on any of more than 50 mycotoxins in a sample in one report.

To complement these new capabilities, the Centre also provides enhanced technical support: sample validation, troubleshooting and insight into best practices are all available. Romer Labs experts provide advice to help customers remain productive and compliant with local and international regulations.

The APAC Solutions Centre is also introducing a new service to the region: customized training programs. Workshops, webinars and personalised instruction are all designed to adapt to how, where and how often customers test. Romer Labs issues training certificates and other documentation that may be necessary for audits and accreditations.

Yong Wee Liau, Managing Director, Romer Labs APAC: “For years, we have prided ourselves on being an extension of our customers’ labs. With the Romer Labs APAC Solutions Centre, we aim to go beyond that by being with our customers every step of the way. The new Centre has been designed with their needs in mind to help them meet their food and feed safety goals.”

For inquiries, please contact:

Dalya Tay
Senior Regional Marketing Executive
dalya.tay@romerlabs.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

Romer Labs is a unit of ERBER Group.

The AgraQuant^® Mollusk test kit is an enzyme-linked immunosorbent assay (ELISA) and is extremely sensitive. It is also easy-to-use and shares virtually the same extraction procedure with all other allergen AgraQuant^® kits. 

Eva Wanzenböck, Managing Director, Romer Labs: “Accurately labeling food for allergenic content or producing allergen-free food are just two of the most formidable challenges that today’s food producers face. Reliable, fast and quantitative diagnostic solutions are essential not only in helping them to do their job, but also in protecting millions of allergic consumers worldwide. With shellfish allergy estimated to affect up to 2.5% of the world’s population, AgraQuant® Mollusk has an important role to play in informing consumers and keeping them safe.”

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
Telephone: +43 2782 803 0
E-mail: joshua.davis@romerlabs.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

Romer Labs is part of ERBER Group.

Other topics: 

•    emerging allergens and labelling
•    risk management and root cause analysis
•    the importance of allergen management
•    cleaning validation and verification
 

A Q&A with the expert panel gave delegates the opportunity to ask and clarify points.

Romer Labs UK runs two workshops per year for clients. The next workshop will be held in the North of England in late spring. Details will follow.

To find out more, please contact UK and Ireland sales managers Jeanette Long (jeanette.long@romerlabs.com) or Rachel Scott (rachel.scott@romerlabs.com). 

Julie Sundgaard, Managing Director, Romer Labs North America: “Regulations relating to the import, export and use of GMOs in both food and feed can be a minefield. This means that producers and traders of grain and feed need to know whether their ingredients or formulations contain transgenic proteins. Our new AgraStrip® combs combine unparalleled coverage of GM events for corn and cottonseed with the ease of use that has become the hallmark of all our AgraStrip® solutions. The tests are simple and effective, providing a qualitative, ‘yes or no’ test result after a maximum of 10 minutes of incubation at extremely low LODs.”

Order the corn comb and the cotton comb from the Romer Labs online shop (US only).

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
Telephone: +43 2782 803 0
E-mail: joshua.davis@romerlabs.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

Romer Labs is part of ERBER Group.

PAL stands for "precautionary allergen labeling", and it's everywhere these days. "May contain nuts." "Processed in facilities where soy has been processed." Such statements don't always assess actual risk and can cause more than a few headaches for allergic consumers, whose choices of food are already limited.

In this issue of Spot On, we investigate methods and practices that can make labeling be what it should be: accurate, informative, and science-based.

In this issue:

• The problem with precautionary allergen labeling
• The VITAL^® Program
• Food allergen reference doses
• 10 “Musts” of food allergen testing

Enjoy this issue of Spot On.

While we are sporting a modernized, more streamlined look, there’s more than meets the eye. Just log in (or create an account if you don’t already have one) and enjoy these new features, right at your fingertips:

• New online shop – US customers can place orders now! Customers in other countries can always request a quote.
• Comprehensive product information – Safety data sheets and package inserts are all available when you’re logged in.
• Full integration – Everything is now in the same place. View order status and download invoices from previous purchases and certificates of analysis.

Log in now

In this initial phase, only customers in the United States can place orders, download invoices and documents related to previous orders. The full functionalities of the online shop, including order placement and invoice history, will gradually be opened up to users in other countries.

For more information, check out our press release (PDF).

“Professionals in the food and feed industries have always expected innovation from their business partners,” said Eva Wanzenböck, Managing Director, Romer Labs. “But innovation should not be limited to R&D projects or diagnostic solutions. Today’s marketplace expects innovation in how customers educate themselves and the way products and services are delivered. Our online shop is just one of our many initiatives to meet this expectation.”

The online shop is fully integrated into the Romer Labs website, which has also been modernized. Visit romerlabs.com for more details.

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
Telephone: +43 2782 803 0
E-mail: joshua.davis(at)romerlabs.com
 

Event Venue:

Belfast Waterfront
2 Lanyon PI
Belfast BT1 3WH
UK

For further information, please visit: https://www.worldmycotoxinforum.org/

Featuring an LOD of 10 ppm for coconut in food matrices, beverages and rinse waters, the AgraStrip® Coconut test kit brings a much-needed solution to food producers looking either to prevent coconut contamination or to inform their consumers with accurate labeling regarding coconut content.

AgraStrip® Coconut kits are highly sensitive immunochromatographic LFDs designed for the detection of coconut in foods and beverages and for the validation and monitoring of cleaning procedures by testing rinse waters and environmental swab samples.

Though relatively rare, all documented cases of coconut allergy have manifested as anaphylactic reactions, which can be lethal when not promptly treated. Thanks to its inclusion as a “tree nut” in the “Big 8” list of food allergens, coconut is gaining in awareness as a significant food allergen. It is a very versatile ingredient, appearing in cosmetics and foods in the form of coconut water, coconut milk and powder, coconut cream and fresh and dried coconut meat or flour.

“We are proud to add yet another testing solution to our already comprehensive AgraStrip® line of solutions with the AgraStrip® Coconut test kit,” said Eva Wanzenböck, Managing Director, Romer Labs. “The AgraStrip® Coconut kit has the same advantages that our customers have come to expect from the AgraStrip® line: a very fast time-to-result of 11 minutes including extraction, stability at room temperature, a long shelf life and at 10 ppm coconut one of the lowest LODs around. All AgraStrip® test kits share the same extraction procedure for allergenic analytes, making the whole portfolio an industry leader in convenience and accuracy.”

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
Telephone: +43 2782 803 0
E-mail: joshua.davis@romerlabs.com

About Romer Labs
Romer Labs is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

The newer, 2017 edition of ISO/IEC 17025 addresses current industry needs and accounts for the methods and activities of today’s laboratories. Substantive changes include a new structure adopted to align it with other existing ISO/IEC conformity assessment standards, such as ISO/IEC 17000. It also adds a risk- and process-based approach that matches those of newer standards such as ISO 9001.

Lee Jiuan Chin, Laboratory Manager of Romer Labs Singapore, was delighted at this additional recognition: “Obtaining the updated ISO 17025:2017 accreditation reflects both our dedication to good industry laboratory practices and our commitment to food and feed safety.”

Romer Labs is celebrating this new accreditation by offering customers a complimentary mycotoxin screening until December 2019. For more information, please visit www.romerlabs.com/en/products/analytical-service/mycotoxins/singapore/.

For inquiries, please contact:
Dalya Tay
Romer Labs® Singapore Pte Ltd
Telephone: +65 6631 8057 
E-mail: dalya.tay@romerlabs.com

About Romer Labs®

Romer Labs® is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

So what do we mean when we say that something is "GMO-free"? It's a simple question that leads to complex answers with ramifications in production, traceability and labeling practices. In this issue of Spot On, our experts provide some tips on how to decode this shifting regulatory landscape.

In this issue of Spot On:

• Examples of differing labeling laws
• Product-based and process-based definitions of GMOs
• 4 crucial questions for GMO testing
• New labeling regulations in the USA

Enjoy this issue of Spot On.

RAFA 2019 will provide an overview of contemporary trends in analytical and bioanalytical strategies in food quality and safety control. This bi-annual event gathers industry experts from all around the world to discuss challenges and innovative solutions in the industry.

Visit us at our booth and learn how we can make our decades of experience in food safety work for your business.

Here you can find more information about the event.

Event Venue:
CPI Hotels, a.s. Clarion Congress Hotel Prague
Freyova 33, 190 00 Prague 9 – Vysocany
Czech Republic

Watch and discover:

• Global regulations on allergen management and product labelling
• Allergen risk assessment
• Sampling plans and strategies
• Methods of analysis and applications to different processes

Enjoy this issue of Spot On!

As Silver Sponsors, we participated with a stand, where interested event participants had the chance to come and talk to us about our allergen products and services.  

The participants were particularly interested in our fast, on-site methods, including lateral flow devices (LFDs), as quality management often requires a fast decision whether goods fulfill their defined quality criteria. To quickly analyze and draw these conclusions, these rapid test kits are an essential and efficient tool as they can be maintained on-site as well as in the lab and allow a rapid analysis of a wide range of food and environmental samples within only 11 minutes (including extraction), with everything you need included in the kit.

Want to know more about our AgraStrip range? Head over to our allergen products or contact us!

How does ergotism impact humans and animals? What are current regulatory trends? What are recent relevant analytical developments?

Watch the video and learn more about:

• Ergot alkaloids as an emerging mycotoxin
• The impact of ergotism in the food chain
• Recent developments and discoveries
• Innovative technologies for the detection of ergot alkaloids

• The results of the BIOMIN World Mycotoxin Report for 2018
• Upcoming mycotoxin threats to poultry, swine and ruminants worldwide
• The dangers posed by the presence of multiple mycotoxins
• The potential of multi-mycotoxin analysis
• Innovative technologies for mycotoxin deactivation

This certification, obtained for the analysis of Aflatoxin B1 as part of a multi-mycotoxin LC-MS/MS method, specifically guarantees that the analysis of feed materials, premixes and feed samples is performed in a manner that assures the reliability of its results.

“We are delighted to join our colleagues in Austria as a GMP+ Registered Laboratory,” said Yong Wee Liau, Managing Director of Romer Labs® Singapore. “The GMP+ B11 certification further confirms the excellence of our analytical services in mycotoxin detection and is a fine complement to the ISO certifications we already have.”

She continued: “An important component of the GMP+ scheme is the explicit commitment to continuous improvement. This is one way we fulfill our pledge to reliability, transparency and traceability in the feed production and supply chain.”

Romer Labs® currently operates four fully accredited service laboratories in Austria, the United Kingdom, Singapore and the United States. Beyond mycotoxins, Romer Labs® offers analytical services for a broad range of analytes, including GMOs and food allergens.

For inquiries, please contact:

Dalya Tay
Regional Senior Marketing Executive, Romer Labs® Singapore
Telephone: +65 6631 8018
E-mail: dalya.tay@romerlabs.com

About Romer Labs®

Romer Labs® is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

10 December 2018

Since its founding in Washington, Missouri in 1982, Romer Labs^® has grown to serve producers of food and feed around the world. Its 1999 acquisition by the ERBER Group laid the groundwork for an ambitious expansion course that has seen the company become a world leader in both rapid test kits and analytical services with four worldwide service labs, one of them now housed in the new facility in Tulln.

Erich Erber, Founder and Chairman of the ERBER Group Supervisory Board, opened the gathering with some words on the growth of the ERBER Group and the importance of the Tulln site: “We have decided to invest in Austria, sustainably and for the future, as ERBER Group. This attests to a growth trajectory that is clearly international and, at the same time, has an Austrian focus—the new Romer Labs^® facility in Tulln is just one of many steps we will be taking over the next few years, and it truly demonstrates that we have ambitious goals on the market. It is a big step toward a future that continues to be successful for the entire ERBER Group.”

Jan Vanbrabant, Chairman of the ERBER Group Executive Board, agreed: “Sales at Romer Labs^® have doubled in fewer than four years. Over the next 5 years, Romer Labs^® will strive to double sales again and will make a valuable contribution to the entire group’s organic growth.”

“Now that we have research and production under the same roof, we can increase our agility considerably,” said Eva Wanzenböck, Managing Director, Romer Labs^®. “This will enable us not only to respond faster to the demands of the marketplace but also to anticipate them.”

Dignitaries who addressed the gathering included the Provincial Minister for Economy, Tourism and Sport for Lower Austria Petra Bohuslav, Mayor of Tulln Peter Eisenschenk, Vice-President of the University of Life Sciences and Natural Resources (BOKU) Sabine Baumgartner, and Professor Rudolf Krska, head of the Department of Agrobiotechnology at BOKU.

Pictured above (left to right): Jan Vanbrabant, PhD (Chairman of the Executive Board ERBER Group), Dr. Eva Wanzenböck (Managing Director Romer Labs^®), Ing. Erich Erber, Phd h.c. (Founder and Chairman of the ERBER Group Supervisory Board), Provincial Minister of Lower Austria Dr. Petra Bohuslav and Mayor of Tulln Mag. Peter Eisenschenk. Photo credit: Sebastian Phillipp.

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs
Telephone: +43 2782 803 0
E-mail: joshua.davis@romerlabs.com

About Romer Labs^®

Romer Labs^® is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

At the Romer Labs booth, attendees took advantage of the opportunity to learn more about Romer Labs solutions for food safety and quality. Romer Labs was also represented in the program of speakers and presenters: Product Manager Christina Huber discussed the importance of antibodies, and Barbara Cvak spoke about strip tests in a changing market place.

For more information about the event, please visit: https://www.rapidmethods.eu/

This certification, obtained for the analysis of Aflatoxin B1 as part of a multi-mycotoxin LC-MS/MS method, specifically guarantees that the analysis of feed additives, feed materials, premixes and feed samples is performed in a manner that assures the reliability of its results.

“The GMP+ B11 certification is an important step for us,” said Helmut Rost, Laboratory Manager of Romer Labs^® Diagnostic GmbH. “We have proven not only that we adhere to the criteria of the ISO certifications we already have, but also that we are committed to continual improvement of our analytical services.”

He continued: “While this GMP+ B11 certification emphasizes the quality of our services, we also take it as a welcome challenge to continually strive for excellence. It is not enough just to be accurate; we also aim for reliability, transparency and traceability in our work. The GMP+ B11 certification is part of the promise we make to our customers.”

Romer Labs^® currently operates four fully accredited service laboratories in Austria, the United Kingdom, Singapore and the United States. Beyond mycotoxins, Romer Labs^® offers analytical services for a broad range of analytes, including GMOs and food allergens.

For inquiries, please contact:

Joshua Davis
Communications Manager, Romer Labs® 
Telephone: +43 2782 803 0
E-mail: joshua.davis@romerlabs.com

About Romer Labs®

Romer Labs^® is a leading global supplier of diagnostic solutions for food and feed safety. We offer a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, we operate four accredited, full-service laboratories on three continents.

Cleaning regimens are subject to rigorous validation. Global Food Safety Initiative (GFSI) retailer approval schemes such as the British Retail Consortium (BRC) state, “Where cleaning procedures are part of a defined prerequisite plan to control the risk of a specific hazard the cleaning and disinfection procedures and frequency shall be validated…” In simple terms, this means that the validation process should demonstrate that the cleaning procedure a site is using reduces the hazard – in this case, an allergen – to a level deemed to be acceptable.

The validation guidelines at Holchem Laboratories Ltd. have been developed in accordance with the principles of the European Hygienic Engineering and Design Group (EHEDG) Cleaning Validation subgroup1 and Campden BRI2, together with in-house best practices. The overarching principle can be summed up in this way: validation should be carried out under worst-case scenarios. Here, we take a look at the steps involved in setting up a validation program and then verifying that program.

Such processing effects must be taken into account when developing new analytical methods, either by improved extraction methods intended to increase the solubility of the aggregated proteins or by going back to basics and raising new sets of antibodies that specifically target processed allergens. 

In this issue of Spot On, we investigate new methods for testing processed foods and the potential of incurred reference materials.

We also take a look at the practical aspects of one of the most essential elements of allergen management programs: cleaning procedures

Enjoy this issue of Spot On!

Keeping the food process environment clean is key to avoiding cross-contamination. National and international regulations require the food industry to ensure that foodstuffs placed on the market are safe for consumption and are under specifically defined thresholds for (if not free from) chemical, physical, biological and allergenic traces. In the European Union, for example, EC/178/2002 states that products may not be injurious to health or unfit for human consumption.

Cleaning validation plays a crucial role in quality control by demonstrating that a documented cleaning plan works as it is intended to work. Validations should be carried out on a regular basis and include, if necessary, a documented corrective action. Products, equipment, personnel, protective clothing and other items in the production process are subject to cleaning validation, though it is important to keep in mind that the validation should be based on the associated level of risk. Everything that could be a potential source of cross-contamination should be taken into consideration.

How do you know if it’s clean?

The first step for a proper cleaning validation is to determine how clean is clean enough. In other words, what are the acceptance criteria? These can be measured in cfu/ml (colony forming units per milliliter) or cfu/cm² for microorganisms and µg/cm² for chemicals or allergens. ATP test systems can also be used to check the surface for residues, but this will not work in all environments: for meat or fresh fruit production, ATP levels will be much higher than in a bakery. There is a simple reason for this: after a living cell is destroyed, the ATP degrades. For ATP tests, pass and fail limits of cleanliness should be determined by the facility and documented as to how they were determined.

Microbial cleaning validations should always include indicator organisms and important pathogens. For ready-to-eat products, for example, these may be Salmonella or Listeria spp., the acceptable limit of which is always at zero. Though there are several different methods on the market to monitor for pathogens, the gold standard is culturing, which relies on multiple enrichments and petri dishes. These, in turn, rely on a proper environmental sampling method.

How do you take samples in your process environment?

Generally, there are four ways to take samples from the process environment: swabs, sponges, direct methods (contact plates, dip-slides), and rinse water. Swabs are suited for gaps and corners while sponges are better suited to test larger surfaces. The use of a direct method such as a contact plate or a dip-slide does speed up the sampling procedure and reduce the requirements for other consumables (pipettes, petri dishes, dilution buffer etc.), but it drastically limits the sampling area (approx. 10-25 cm²). Testing rinse water has two advantages: there is no need for a special sampling device and it more accurately represents the sampling area. However, what is gained in scope is lost in precision, as with rinse water the exact location of the contamination cannot be determined.

A cleaning validation is most effective when tailored to a specific production environment. A variety of sampling and test methods may be required to cover all potential sources of contamination.

But what microorganisms should producers be looking for? In this series, we investigate five targets to test for in your production environment, beginning with Listeria and the pathogenic Listeria monocytogenes.

Romer Labs was represented by Chiara Palladino (product manager), who talked about allergens and the difficulties arising from the lack of useful reference materials, as well as by Jiři Macura (sales manager) whose presentation introduced Romer Labs and its product offering in the microbiology sector. 

Romer Labs prides itself on supporting such events and keeping up-to-date with the latest in allergen research, techniques and assessments.

For more information about the Anaphylaxis Campaign, please visit: https://www.anaphylaxis.org.uk/

Romer Labs was supported by external speakers from the Anaphylaxis Campaign, R Ward Consultancy, Holchem Laboratories and the “Just Love Food” Company. 

Yet this isn’t as simple as it sounds.

Food products can range widely from straight raw materials, such as cereals, to highly processed ready-to-eat products. Their composition, moreover, varies according to the amount of protein, fat, salt and other compounds present. Test methods are expected to analyze all food sample types for allergens with equally reliable results. This, however, is often far from achievable in reality.

With all the complexity surrounding food allergen testing, perhaps it’s not surprising that there are a lot of half-truths and myths out there. Here, the allergen experts at Romer Labs dispel six of the most common misconceptions about food allergen testing.

On-site testing vs. analytical service

The first step in finding the right testing solution is to decide whether to conduct the test yourself on-site (e.g. in the field or at the storage or production facility), or to send the samples to an analytical service laboratory. This decision depends on three main considerations:

1) Required testing throughput

For frequent testing (high throughput), it might be worthwhile to conduct on-site tests, since costs are generally lower than those of analytical service labs. If you only perform occasional testing or have low throughput, sending your samples to a lab could be more convenient.

2) Acceptable time-to-result

On-site rapid tests will deliver results within a couple of minutes to an hour, depending on the technology being applied. This makes them a useful tool when decisions have to be made in a short amount of time, as in when deciding whether to accept a truck delivery. From start to finish, external analytical service results can take anywhere from a couple of days to a week.

3) Sensitivity

On-site testing can be categorized as a screening tool in that it quickly assesses the concentration of one analyte per test. Reference methods available at an analytical service laboratory are much more robust and allow testing at lower toxin levels for a larger number of analytes.

Rapid tests

The two most popular on-site methods are strip tests (LFDs, or lateral flow devices) and ELISA (enzyme- linked immunosorbent assay) tests. Strip tests are designed to show results as soon as possible, though they can process no more than two samples at a time. They are therefore often used at reception points in the supply chain of agricultural raw commodities. ELISA kits can test up to 44 samples simultaneously. In general, ELISA might be the better option when six or more samples are under analysis, lowering total testing time and cost per sample.

Check out the latest issue of Spot On!

As part of the benchmark competition, Great Place to Work awarded a total of 44 out of 87 participating companies in four size categories with the title “Austria’s Best Workplaces”. The categories depend on the number of employees in Austria: Small (20-49), Medium (50-250), Large (251-500), X-Large (over 500). The evaluation of the enterprises takes place by means of an employee survey and a company audit.

This sixth and final issue of our series sheds some light on the common misconception that allergen reference materials are available.

In this series, we will shed some light on common misconceptions in allergen testing.

L. monocytogenes is a significant human pathogen that can contaminate, among other foodstuffs, ready-to-eat (RTE) meat and poultry. As with other Listeria species, L. monocytogenes is able to survive and thrive in cool, damp conditions where other bacteria cannot. An aggressive and verifiable sanitation program is therefore necessary to avoid cross-contamination of processing equipment in production plants.

Children and those with weakened immune systems are particularly vulnerable to L. monocytogenes. As a result, the Food and Safety Inspection Service (FSIS) at the USDA maintains a “zero-tolerance” policy for the pathogen in RTE meat and poultry products. The USDA, FDA, EFSA and other national and international regulatory bodies recommend and enforce hygienic measures that call for frequent testing of surfaces in the environment that come into contact with food ingredients as well as finished products.

RapidChek^® Listeria monocytogenes is designed to meet this diagnostic need and provides results days faster than ISO, USDA and FDA methods. It combines a sensitive immuno-detection strip with a single proprietary enrichment media. After enrichment, highly sensitive and specific strips indicate the presence of L. monocytogenes in only 10 minutes.

“We are delighted that our AOAC-certified food pathogen detection tools now include a specific testing solution for Listeria monocytogenes,” said Romer Labs^® R&D Director Kurt Brunner. “Food producers can leverage the same media they prepare for RapidChek^® Listeria NextDay™ to test for L. monocytogenes; if the first test is positive, the same media can be used to deliver results for L. monocytogenes just one day later. Together, these two solutions form a comprehensive system for on-site Listeria detection that helps food producers discover and control the presence of this pathogen in their production facilities.”

He continued: “While the AOAC Performance Tested^SM certification underscores the scientific soundness of the product, RapidChek^® Listeria monocytogenes also has considerable business benefits, including unlimited scalability, ease-of-use with a one-step enrichment process, the need for minimal training, and a long shelf life at room temperature. We are proud to be bringing this new method to the food safety market.”

For inquiries, please contact:
Joshua Davis
Communications Manager
Romer Labs
Telephone: +43 2782 803 0
joshua.davis@romerlabs.com

• Upcoming mycotoxin threats to poultry, swine and ruminants worldwide
• Relevant mycotoxin detection tools to ensure proper monitoring
• The dangers posed by the presence of multiple mycotoxins
• Innovative technologies for mycotoxin deactivation

Organisms that are genetically modified have undergone alterations to their genetic material in a process known as genetic engineering. These alterations result in the organism expressing a trait or traits that would not naturally occur in that organism. GMOs currently exist in bacteria, animals and plants, and are used in a wide range of applications including biological and medical research, the production of pharmaceuticals, and agriculture.

Why GMOs?

One of the most widely adopted uses of GMOs is in agriculturally important crops. In these plants, alterations to the genetic material are often accomplished by inserting DNA material from a different organism into the target organism. This results in the plant (and any seeds harvested from the plant) expressing novel traits, such as herbicide or insect resistance, or quality traits such as drought tolerance. For example, genetic modifications have been made so that plants are resistant to herbicides such as glyphosate or glufosinate, allowing a field to be sprayed with the herbicide to kill off weeds without harming the crop.
Genetic modification can also involve the transfer of a trait or traits that allow the plant to produce endotoxins originating from the soil bacterium Bacillus thuringiensis, known as “Bt”. This confers insect resistance.
These endotoxin proteins have been used as spray-on insecticides since the 1920s. They target certain insect species while having no effect on non-target species such as humans, wildlife, and beneficial insects. When ingested, these proteins form pores in the midgut epithelium of the larvae of susceptible insect species (which feed on the crops, causing damage). This causes paralysis of the gut, and the affected insect stops feeding and succumbs to starvation. Non-target species have no receptors in the gut for the protein, and thus the protein has no effect on them. In addition, GMO plants may express quality traits that allow them to be tolerant to environmental conditions such as drought, or to improve their nutritional content.

GMO naming conventions

GMOs may be referred to in one of three ways. First, they may be identified by their event name, which is the name of the unique DNA recombination experiment that occurred in the laboratory in which one plant cell successfully incorporated a desired gene. That cell is subsequently used to regenerate whole plants and is the “foundation” of a GMO strain. For example, one event name for herbicide-tolerant corn is NK603.
Second, GMOs may also be identified by the unique protein they express. In the case of event NK603, the protein expressed is CP4 EPSPS. Thirdly, the GMO may be identified by the trade name under which it is sold commercially.

GM crops around the world – then and now

Current GMO production mainly comprises four crops: soybeans, maize, cotton, and rapeseed/canola. Global trade of these crops and their main derivatives is dominated by material of GMO origin. In addition, global planting of these four crops includes a very high percentage of biotech seed (78% of soybean, 64% of cottonseed, 33% of maize, and 24% of canola globally; ISAAA 2016). Within these crops, there are several GMO proteins currently important to the grain and seed trade. The cultivation of GM plants is increasing globally, as is the utilization of stacked traits - including two or more novel traits in the same plant.
The first field trials of GM plants began in the United States and France in 1986, with herbicide-resistant tobacco. The first country to allow commercialized GMO plants was China, which introduced a virus-resistant tobacco in 1992. The first GM crop approved for sale in the US was the FlavrSavr tomato in 1994. In that year, the European Union also approved its first GM plant for sale, which was a herbicide-tolerant tobacco. Commercialized cultivation of GM plants such as corn and cotton began in 1996.
In 2016, 11 different types of GM crops were commercially grown on 457 million acres (185 million hectares) in 26 different countries around the world.

To be successful, the Just Love Food Company needed to 

• ensure that its products are 100% free of nuts 
• expand its product line to gluten-free and dairy-free cakes 
• minimize the need for external testing with an in-house solution 
• get quick testing results to preserve the shelf life of its cakes

The Solution

With help from Romer Labs, Just Love Food Company 

• implemented AgraStrip^® test kits on-site to gain independent control of its testing 
• externally validated its testing program 
• scaled its testing to guarantee the safety of all ingredients and products in every batch

The Outcome 

Now Just Love Food Company can 

• read results in 10 minutes on-site at a fraction of the cost of external testing 
• benefit from a comprehensive allergen lab and ongoing technical support for CSS, ELISA validation and sample verification 
• positively verify that all its products are 100% nut-free 
• be confident enough in its processes to bring gluten-free and dairy-free cakes to market

Source: Brunt et al. (1997): Plant Viruses Online: Descriptions and Lists from the VIDE Database. Retrieved from sdb.im.ac.cn/vide/descr184.htm

Over the course of the last decade, a second method of transformation has grown more popular than Agrobacterium: biolistics, also known as the “gene gun” method. In this method, plasmid DNA is coated onto small tungsten or gold beads. These micron-sized beads are then “shot” into the plant tissue. Some of the cells in the plant tissue may successfully take up the new DNA and integrate it into a chromosome. This method has proven effective for integrating DNA into the cell nucleus as well as into organelles such as chloroplasts, and works in almost all species researched. Other methods that have been used include microinjection and electroporation.

Do your homework: this is perhaps the most basic habit any scientist can learn. This is particularly necessary for genetically modified organism (GMO) testing, where doing your homework means knowing which events comprise your targets so that you can avoid false positives and erroneous results.
The problem relates to traits. A trait is a protein derived from a genetic modification which gives a special feature to the plant. Genetic modifications may be present in different combinations that produce similar—or entirely different—traits. Among the most popular elements of genetic modifications are promoters (p35S, FMV), terminators (NOSt), coding genes for certain useful traits (cp4 epsps, pat, bar, Cry1A, and others), and genes coding selective markers (NPTII, PMI).
Your technicians need to consider many different factors in defining the target for any GMO analysis. Make sure you consider the territory the product originates from as well as the possible events, whether these events are authorized in the region in question, and whether the plant of interest has commercially available biotech traits.
It can be tricky: sometimes the modification exists but is not authorized or planted in certain regions. However, it may be widely used in another region. In addition, there have been cases of unapproved events escaping containment and making their way to the field.

2. Choosing a faulty or insufficient method

It can be a risky decision: what should be the scope of any GMO screening? Laboratories can narrowly target a few genetic elements or proteins, or they can expand the scope to several events or proteins, which can be expensive. Finding the method that fits your needs and ensures accurate results is essential.
DNA-based methods are time-consuming and depend on high-quality DNA extraction and proper controls. Copy number variation and polyploidy can also cause problems in samples and should be taken into consideration when performing DNA analysis.
A look at some common plants will illustrate the point. In the case of soybeans, it is not enough to test only for promoters and terminators, because only a few of the 15 potential soybean events contain these common genetic elements. Maize is a different story altogether: broadly screening for these elements is almost completely sufficient, because most events in maize contain these elements.
While DNA-based methods are expensive and used only in analytical service labs, protein identification is relatively cheap and is useful in screening for common traits on-site. The majority of GM events has its own level of modified protein expression. Be careful when carrying out protein analysis of soybean and canola with the same lateral flow device (LFD) strips. Table 1 highlights different expression rates of CP4 EPSPS, making it necessary to use different LFD detection methods in soybean and canola. The right approach uses different tests and adjusts the sensitivity for different commodities to reach a similar level of detection.

ESS was faced with

• annual equipment maintenance cost increases of 10%
• machine downtime
• declining productivity

The Solution:

With help from Romer Labs, ESS

• implemented RapidChek^® SELECT™ Salmonella and Listeria
• scaled up to test a high volume of samples
• avoided the need to invest in expensive equipment

The Outcome:

Now, ESS can

• reduce media costs by 11%
• trim material and labor costs by up to 25%
• read results in 10 minutes, resulting in quicker turnarounds for customer samples

This fifth part of our series explains why results from different test kits are not always comparable.

>> Watch this video to find out more.

It makes more sense to test for allergens earlier, hence the common industry practice of surface sampling. Check out this short explainer video to see how AgraStrip® lateral flow strips can substantially improve your allergen management workflow.

For all this and more, check out the latest issue of Spot On!

Endyne was confronted with

• ambiguous test results
• labor-intensive methods
• inefficient lab processes
• weekend work driving up lab overhead 

The Solution:

With help from Romer Labs, Endyne

• implemented RapidChek^® SELECT™ Salmonella and Listeria
• redesigned workflows and processes to reduce hands-on time and transfers
• increased flexibility to run weekend samples

The Outcome:

Now, Endyne technicians can

• hold down costs for technician overtime and total overhead
• simplify and speed up workflow to accommodate weekend samples
• better customize their service to meet their customers’ needs

Sending samples to a service lab takes days for a result. Some in-house test methods like ELISA are often time consuming and require skilled operators. And yet, testing needs to be done.

That’s why we developed our AgraStrip^® WATEX^® lateral flow devices. Check out this short explainer video to see how AgraStrip^® lateral flow strips can substantially improve your mycotoxin testing workflow.

This will allow us not only to better serve you, our customers, but also to reduce the number of prints and paper we ship around the world with our products.

Check out our Customer Resources

Don't miss this exiting line-up of topics!

Enjoy your reading!

Analysis of mycotoxins based on LC-MS/MS

Analytical methods based on reversed-phase LC coupled to MS (LC-MS/MS) have become a powerful and state-of-the-art technique in the qualitative and quantitative analysis of mycotoxins over the last decade.
Advantages of this method are the high sensitivity and selectivity, the application to multi-mycotoxin analysis as well as the delivery of additional information about mass-to-charge ratios (m/z) and fragment ions of the investigated analytes.
Currently, there is a strong trend towards the application of multi mycotoxin methods achieved by LC-MS/MS. The simultaneous determination of a wide range of mycotoxins belonging to different chemical families within one single measurement can be achieved using this technique.
However, issues like the chemical diversity of the compounds themselves, the wide range of agricultural commodities being tested, varying concentration ranges and different occurrence distributions all challenge method development and optimization. Therefore, compromises must be made in the choice of extraction solvent and mobile phase, and conditions may be far from optimal for certain analytes, which include acidic (fumonisins), basic (ergot alkaloids), as well as polar (moniliformin, nivalenol) and apolar compounds (zearalenone, beauvericin). In addition, the lack of suitable commercially available analytical standards for certain analytes results in only qualitative screening statements rather than quantitative results.

This fourth part of our series sheds some light on the misconception that mass spectrometry will soon replace rapid tests as the future gold-standard of allergen testing.

Romer Labs Deutschland will continue to offer an extensive range of innovative testing solutions and services alongside those already part of the established Coring GmbH portfolio.

Romer Labs was founded in 1982 and is represented in more than 60 countries worldwide, either directly or through dedicated distributors. The company offers a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, it operates four accredited service laboratories in Austria, the UK, Singapore and the USA.

Coring was founded in 1987 and has a 30-year success story in the sales and distribution of diagnostic solutions.

”After the successful integration of the Transia GmbH business into Romer Labs earlier this year, it was a clear next step to also integrate the experience, skill and knowledge that our distribution partner Coring has. Our customers will now benefit from an extensive product portfolio, excellent customer service, an expanded distribution network and 60 years’ worth of experience in the field of food and feed safety,” says Thomas Weber, Managing Director of Romer Labs Deutschland.

In case of inquiries, please contact:
Thomas Weber
Romer Labs Deutschland GmbH
Schorbachstraße 9
DE - 35510 Butzbach
Telephone: +49 6033 7480 100
Email: thomas.weber@romerlabs.com

Perhaps the answer lies in water.

Why hasn’t water been used from the very beginning?

While fumonisin and deoxynivalenol are easily extracted using water, other mycotoxins like aflatoxins or zearalenone are not very water soluble.
This has led to the use of hazardous organic solvents like chloroform, acetonitrile and methanol in the extraction process, although laboratories are well aware of the downsides of using solvents, such as their high purchase and disposal costs, and issues associated with environment and operator safety.
To utilize water efficiently in an extraction process,some basics should first be understood.

The polarity of substances

The transfer of mycotoxins from grains into a liquid is not as easy as it seems. It depends foremost on the physical properties of the mycotoxin to be extracted, with polarity playing a major role in this context.
As the building blocks of molecules, atoms and how they are arranged can exhibit different electrical charges. Mycotoxins can exhibit positive charges on one side and negative charges on the other. In such cases,the molecule has electrical poles and is called polar.
As such, all substances including mycotoxins, are organized into three major groups:

1.) Polar substances like water

2.) Nonpolar substances like oil

3.) Amphiphilic substances like soap that have both polar and nonpolar properties

Polar molecules are also called “hydrophilic” fromthe Greek word “water loving”, as they are soluble in water. Their attraction to each other is based on their electrical charges. The negative pole of one molecule is electrostatically attracted to the positive pole of another molecule. This sticking to each other is the reason why they are miscible.
Salt and sugar are examples of solid polar substances. Sugar is perfectly soluble in liquids like coffee, but also attracts moisture from the air. For the same reason, salts are often used as desiccants. On the other hand, nonpolar molecules are called hydrophobic or “water fearing”. Their attraction to each other is a result of a joint repulsion of water and other polar substances. Amphiphilic molecules have both nonpolar and polar properties. Soap, for example, can attract greasy (nonpolar) stains from skin, hair or clothes and at the same time, bind to water (polar) to wash them off.

Many different cereal plants and grasses, including rye, wheat and triticale among others, can become infected by these fungi during cool, wet weather conditions. These fungi then produce structures called sclerotia. These sclerotia contain different classes of ergot alkaloids, the most prominent being ergometrine, ergotamine, ergosine, ergocristine, ergocryptine and ergocornine together with their epimeric –inine forms. If grains containing sclerotia are processed by grinding into flour, high contamination levels of ergot alkaloids typically follow.

Currently, available data on ergot alkaloids show that the intake of contaminated food or feed can severely affect animals and humans. Ergot poisioning is called ergotism, a severe pathological syndrome. Symptoms include hallucinations, itchy and burning skin, nausea, dizziness and even abortion. Ergotism is one of the oldest known diseases caused by mycotoxins and was first described in the Middle Ages as so-called St. Anthony’s fire.

Furthermore, ergot alkaloids are not only known as mycotoxins. Ergotamine, for example, is one of the components of the psychoactive drug lysergic acid diethylamide (LSD). Ergot alkaloids are also used for medicinal purposes, including the treatment of migraines and the induction of birth process among others. Up to now, the amount of ergot alkaloids present in food and feed is not regulated, but regulations are under strong discussion in the European Union.

Currently, the most widely used detection method for ergot alkaloids is based on HPLCFLD (High Performance Liquid Chromatography with fluorescence detection) and can be performed using calibrants and a one-step cleanup provided by Romer Labs. An official CEN LC-MS/MS (liquid chromatography – mass spectrometry) method is currently under development.

Every truck is probed and analyzed consecutively; hence a quick, easy-to-use, single sample test method is required. Lateral flow device (LFD) tests, also known as strip tests or dipsticks, are one of the fastest test methods available and a perfect fit for this scenario. Due to their simplicity, these tests can be performed by almost anyone with basic training and typically produce analytical results in just under ten minutes.
This enables quick decisions on whether a truck’s payload can be accepted into the grain elevator’s facility.

Incurred sample controls and immunoassays that can reliably detect processed allergens are key to being able to fully support the food industry with their future analytical needs.

The ERBER Group divisions includes international animal nutrition company, BIOMIN and leading diagnostic solution provider for the agricultural, food and feed industries, ROMER LABS.

“The growth and success that both BIOMIN and ROMER LABS continue to have serving customers over the years provided a clear logic for nurturing their strong potential going forward,” explained Jan Vanbrabant, Chairman of the Executive Board of ERBER Group. “We have an ambitious plan for North America, and ultimately it is our customers who will benefit,” he added.

Central U.S. hub

“We are excited to continue our long-term commitment to investing in the North American market. The central location will allow us to improve the infrastructure support across the group, and bring us closer to more of our customers,” stated Mr Vanbrabant.

The hub, modeled on the success of the ERBER Group structure in Asia Pacific and in Europe, will create new, shared support functions, including infrastructure and IT, for the ERBER Group divisions. Being situated together in one location will encourage and promote internal synergies both within and across the teams.

“Introducing a hub to North America embodies the ERBER Group vision and mission of delivering innovation on an international scale to our customers, while integrating efficiencies into our day-to-day lives,” added Mr Vanbrabant.

BIOMIN pursues growth

Over the past two years, BIOMIN has significantly expanded its support for customers in North America through the introduction of new products and services along with robust recruitment. In the United States alone, BIOMIN has added six key account managers, five technical support managers and a sales director swine.

“The expanded product and services portfolio along with greater technical support have enabled us to help customers achieve tangible improvements in their operations,” explained Simon Walley, President of BIOMIN North America. “We intend to replicate the success we’ve seen with clients in the poultry and swine sectors in the ruminants industry,” he added.

ROMER LABS continues success

Alongside its innovative diagnostic solutions offering, ROMER LABS operates an accredited full-service laboratory in the US and three others globally.

“Our customers will continue to receive the same high quality products and services they have come to appreciate,” commented Michael Prinster, Managing Director ROMER America. “There will be no interruption with the implementation of the new hub: we expect to seamlessly improve synergies within the group,” added Mr Prinster.

ROMER LABS will continue to operate facilities in Union, Missouri and Newark, Delaware.

article on ergot alkaloids

article on Alternaria toxins

Modifying mycotoxins as plant defense

Typically, mycotoxins are explicitly produced by fungi and their parent structure is often modified by the fungus itself which releases a cocktail of structurally related compounds. During infection, these substances are then often further modified by the host plant of the fungus. The living plant might change the chemical structure of toxins and produce so-called masked mycotoxins.
The formation of these masked toxins is a major detoxification strategy of crops, as they are less toxic for the plant. Usually, a glucose molecule or a sulfate is involved in the conjugation and detoxification. Although these masked toxins do not further harm the plant, their toxicity to humans and animals might reemerge when the added masking molecule is cleaved in the gastrointestinal tract of mammals during digestion (Figure 1). In plant breeding, the increasing occurrence and production of some masked mycotoxins might be linked to novel resistant breeds. Deoxynivalenol-3-glucoside, for example, has been reportedly linked to resistance against Fusarium head blight. This means that Fusarium resistant plants have been proven to show higher deoxynivalenol-3-glucoside to deoxynivalenol ratios, but these are accompanied by lower levels of total deoxynivalenol and the modified form due to higher Fusarium resistance.

The new entity, Romer Labs Deutschland, will offer an extensive range of innovative testing solutions and services in addition to the established product portfolio of the former Transia GmbH.

Romer Labs was founded in 1982 and is represented in more than 60 countries worldwide either direct or through dedicated distributors. The company offers a broad range of innovative tests and services covering mycotoxins, food pathogens, food allergens, gluten, GMO, veterinary drug residues, and other food contaminants. Furthermore, it operates four accredited service laboratories in Austria, the UK, Singapore and the USA.

Transia was founded in 1988 and has a history of almost thirty years in the field of food safety.

"With the successful integration of Transia into Romer Labs, our customers can now benefit from over 60 years’ worth of experience in the field of food and feed safety. The renaming of TRANSIA to Romer Labs Deutschland is an important step for our employees as well as for our business partners,” says Thomas Weber, Managing Director of Romer Labs Deutschland.

In case of inquiries please contact:

Thomas Weber
Romer Labs Deutschland GmbH
Schorbachstraße 9
DE - 35510 Butzbach
Telephone: +49 6033 7480 100
Email: thomas.weber@romerlabs.com

• How to implement rapid on-site mycotoxin monitoring
• Overcoming some common on-site testing challenges
• Current mycotoxin threats to poultry, swine and ruminants worldwide
• Dangers posed by the presence of multiple mycotoxins
   

“The test kits are optimized to extract mycotoxins using distilled water in combination with an extraction buffer. That and the fact that the same extract can actually be used to test for multiple mycotoxins, make AgraStrip^® WATEX^® the product of choice for simple, fast and eco-friendly mycotoxin detection.” says Dr. Kurt Brunner, R&D Director at Romer Labs.

Accuracy and robustness have been once again confirmed by the recent GIPSA approval for AgraStrip^® ZON WATEX^®, the product becoming the first and so far only water-based zerealenone test kit to successfully pass the GIPSA performance test.

AgraStrip^® WATEX^® test kits are quantitative tests. Used with the AgraVision^® reader, these test kits provide objective results and secure a consistent result documentation.

All test kits come with Whirl-Pak^® bags that contain integrated filter membranes. As such, there is no longer any need for additional extract clarification equipment like centrifuges or filters.

The incubator that controls the ambient test temperature and the dust- and dirt-resistant AgraVision^® reader make the AgraStrip^® test system very robust and well suited for on-site mycotoxin testing.

For more information please visit: https://www.romerlabs.com/en/watex/

Topics covered include:

• What an allergic reaction is and its impact on the food allergenic consumer.
• Current Reliability of Allergen testing – featuring the pros and cons of current technologies, future development and potential new novel technologies;
• Current legislation and its limitations – The role of food allergen risk assessment/management in the food industry.

Moderator:

• Bert Popping, Chief Scientific Officer - Corporate Food Chemistry and Molecular Biology, Mérieux NutriSciences

Speakers:

• Adrian Rogers, Senior Research Scientist, Romer Labs UK (his part starts at 50:30 min)
• Professor Clare Mills, Professor of Molecular Allergology, University of Manchester
• Rene Crevel, Science Leader - Allergy & Immunology, Unilever
• Ashley Sage, Senior Manager - Market & Business Development EMEAI, SCIEX

watch now

But that's not all! In a subsequent article, Dr. Simon Shane shares his views on how rapid methods can be implemented as on-site tools for pathogen monitoring. And in yet another article, we are putting a lid on 8 myths surrounding pathogen detection.

Don't miss this exiting line-up of topics!

AgraStrip^® WATEX test kits are available for aflatoxins (B1, B2, G1, G2), deoxynivalenol and zerealenone and provide a fast, simple and eco-friendly solution for on-site mycotoxin testing. Tests for total fumonisins and ochratoxin A are in the final stages of development.

“The test kits are optimized to extract mycotoxins using distilled water in combination with an extraction buffer. That and the fact that the same extract can actually be used to test for multiple mycotoxins make AgraStrip^® WATEX the product of choice for simple, fast and eco-friendly mycotoxin detection.” says Dr. Kurt Brunner, R&D Director at Romer Labs.

AgraStrip^® WATEX test kits are quantitative tests. Used with the AgraVision^® reader, these test kits provide objective results and secure a consistent result documentation.

All test kits come with Whirl-Pak^® bags that contain integrated filter membranes. As such, there is no longer any need for additional extract clarification equipment like centrifuges or filters.

The incubator that controls the ambient test temperature and the dust- and dirt-resistant AgraVision^® reader make the AgraStrip^® test system very robust and well suited for on-site mycotoxin testing.

Environmental pathogen testing isn’t improving my food safety program

Most regulations for pathogens require end-product testing before a food production lot can be safely released for distribution and retail. However, there are several challenges associated with the testing of end products.

Firstly, variables such as background microflora, inhibitory characteristics, pH level and salt concentration make pathogen detection difficult. Secondly, sampling methods and sample heterogeneity can lead to inaccuracies, especially if levels of contamination are very low. How can food producers be confident that the number of samples tested is sufficient to ensure that the lot is entirely free of dangerous pathogens? Environmental testing has proven to be a very useful tool in many food safety programs and adapted as part of preventive controls under the FDA Food Safety Modernization Act (FSDA). Environmental monitoring programs (or EMPs) allow a food producer to find growth niches in production areas and take action to eliminate any risk associated with food contamination. Areas with a high risk of pathogen contamination should be sampled, as the purpose of environmental testing is to find positives. The goal of monitoring is to eradicate potential pathogens from the facility and production line before actual contamination takes place, and give food producers an early indication of any contamination risk/problem.

Myth 2

In-house pathogen testing requires substantial investments

Service labs often tell customers that it is too expensive and laborious to test for food pathogens in their own facility. That might be true if standard procedures (FDA BAM, ISO) are used, as these generally require a lot of hands-on time. Other methods such as ELISA and real-time PCR require expensive equipment. In fact, the only equipment you need for in-house tests are an incubator for the enrichment phase and a scale to weigh samples. An autoclave is optional, and only if you wish to sterilize your own media or for waste disposal. There may also be a need for a separate room for enrichment and testing. When using lateral flow strips, there is no need for any extra equipment to interpret the results and therefore, no substantial investment is necessary.

Myth 3

Pathogen testing requires well-trained staff

Rapid methods for pathogens have been streamlined from the days when only highly trained microbiologists could administer such tests, along with countless tubes, plates and a discerning eye. A variety of skill sets are still required, depending on the method but many test kits can be run effectively by trained staff.

Not all test methods require highly educated staff. In many companies, lab staff may have been transferred from the production plant and may not have a scientific degree. Test methods should therefore be simple and robust, with minimal steps to help streamline workflow in the lab and minimize the chance of errors.

A lab must also be able to demonstrate that their staff have been trained in the prevailing test method. Some companies also participate in proficiency test programs to ensure that their lab staff can work independently to obtain accurate test results.

Myth 4

Lab safety requirements deter small companies from conducting their own tests

Food pathogens in the so-called risk group 2, such as Salmonella, Listeria and E.coli O157, can be handled in rooms with some minor adjustments. Pathogens in this risk group are not considered hazardous to laboratory workers and the community in general.

According to the EN 12128 (European Standard), Biosafety in Microbiological and Biomedical Laboratories (US Centers for Disease Control and Prevention) and the World Health Organization (WHO) Biosafety Manual, such rooms should be marked with the biohazard symbol and have access restricted. Only those working with the pathogens should have access to this lab room.

The surfaces in the room need to be resistant to chemicals and therefore also to disinfectants. These lab safety requirements can be easily managed by small food producers.

Myth 5

I cannot dispose of contaminated test material

Yes you can. Here are three options for safe disposal:

1. Use an autoclave and set the temperature at 121°C for at least 20 minutes. The material can now be safely disposed of as residual waste.
2. Use a microwave disinfection system. The material can now be safely disposed of as residual waste.
3. Delegate a waste company for that task. They will order special containers to collect the contaminated waste and discard it for you.

Egg quality assurance programs

During the late 1990s, individual states introduced the Egg Quality Assurance Programs requiring producers to conform to minimal standards of biosecurity, post-pack refrigeration, vaccination, assay of flocks for environmental contamination and diversion of eggs from infected flocks to breaking and pasteurization. The elimination of vertically transmitted infection through successive generations, extending from pure lines to parent stock, was critical to the attainment of a meaningful reduction in  the prevalence of SE in flocks.

The National Poultry Improvement Plan (NPIP) established in the early 1930s is responsible for the coordination of Federal, state and industry activities to eradicate vertically transmitted infections. The Plan mandates operating procedures, approves diagnostic tests and certifies hatcheries supplying day-old chicks and poults.

Originally focused on the eradication of Salmonella pullorum infection, the NPIP is now concerned with SE in laying strains, in addition to other pathogens in a wide range of avian species. Adherence to the requirements of the National Poultry Improvement Plan ensures a supply of commercial replacement pullet chicks from hatcheries certified free of SE. This is an essential foundation of industry efforts to prevent SE in commercial flocks.

In 2003, a nationally distributed brand of eggs introduced a rigorous SE prevention program involving vaccination and enhanced biosecurity required of all franchised egg producers. The use of lateral-flow immunoassay test kits was central to the successful implementation of the program. Since flocks were screened five times from the day of placement to the end of the second cycle of production, a rapid test with appropriate parameters was required in place of the conventional Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) microbiological procedure.

RapidChek^® SELECT™ - a highly sensitive test

The Romer Labs RapidChek^® SELECT™ lateral flow immunoassay has become the standard screening procedure to determine the presence of a Group D1 Salmonella in manure drag swabs or in egg pools. The procedure is regarded by the FDA as equivalent to the more laborious and expensive BAM methodology. Following the initial evaluation of the RapidChek^® method, it was determined that the test demonstrated a sensitivity of 100 percent, critical for a screening test which should not provide false negatives.

Concurrently in the approval process assaying 141 Group D1 Salmonella isolates and 210 non-Group D1 Salmonella serotypes, the specificity of the test was determined to be 93 percent. This is an important parameter since a false positive assay from a 45-week old flock of 125,000 hens will incur substantial costs and disrupt operations.

Applying the BAM method a commercial laboratory examined 2,412 drag swab samples in 2010, yielding 1,477 “suspicious” colonies requiring further examination. From this complement only two SE positive samples were confirmed. The combined results from two mid-West state laboratories applying the RapidChek^® assay in 2010 and 2011 yielded 106 “presumptive” positives from approximately 14,000 drag swabs examined.

Confirmatory bacteriologic assays identified 16 SE isolates from the routine samples submitted by producers. Data from a Western state laboratory on 1,162 drag swabs compared the ability of the RapidChek^® assay to detect Group D1 Salmonella against the conventional BAM microbiological assay. Eleven “presumptive” positives were identified using lateral-flow immunoassay compared to three SE positives applying the BAM procedure.

Practical considerations

The specificity of a screening assay is important from the perspective of potential financial loss. It is calculated that if a false positive environmental assay was obtained from a flock at the mandatory 40 to 45 weeks age period, withholding eggs from the market or diverting to breaking and pasteurization over a four-week period during which confirmatory test are performed could cost as much as $75,000 for a flock of 125,000 hens, depending on the prevailing market price of shell eggs and breaking stock.

In 2010, shortly after the introduction of the FDA Final Rule on Prevention of Salmonella, a widespread outbreak associated with one complex in Iowa resulted in an extensive recall ultimately numbering 500 million eggs. This case was an aberration and was due to gross mismanagement and did not reflect current practices in the industry.

In this 2010 outbreak, the initial round of assays derived from the audits conducted by the FDA applying the FDA BAM methodology showed an infection rate of 2.5 percent of flocks examined. This has since declined to negligible levels. There have not been any reported cases of SE attributed to eggs from 2011 onwards. This is due to diligent compliance with the principles of the FDA Final Rule and is based in large measure on the frequency and intensity of environmental monitoring. This would not have been possible without the application of the RapidChek^® SELECT™ SE test, which is used by commercial and state laboratories to conduct screening and compliance assays for the industry.

Epidemiologic evidence demonstrates that SE infection in the poultry industry is now associated with broiler meat and that SE isolates comprise an increasingly greater percentage of Salmonella serotypes recovered from carcass washes. Accordingly, programs of suppression and elimination are being applied, with the SE kit as the preferred screening technique for parent and growing flocks in the U.S. broiler industry.

The false-positive issue

False-positive results may occur with every pathogen detection method. It does not matter if it is a DNA, a biochemical or an immunological based technology. They are all dealing with the same issue of higher sensitivity versus higher selectivity. A good approach is to eliminate cross reacting bacteria before detection, and antibiotics are used for this purpose. But for most applications, antibiotics lack selectivity.

Overcoming the selectivity challenge

Bacteriophages (or phages) are the most abundant organisms in our environment and are present in high numbers in water, food and various other sources. They were discovered by the Canadian biologist Félix Hubert d’Hérelle in 1917. Their name means “bacteria eaters”, which somewhat defines what they do.

Bacteriophages have high host specificity, attaching themselves to bacteria. The big advantage of using phages is, that they are harmless to humans, animals and plants. In fact, humans are routinely exposed to phages through food or water consumption with no negative effects.
Phages can be called “the natural enemies” of the bacteria to which they are specific to. In processed meat and meat products, there are about 108 phages per gram. High numbers of phages are also present in the human gastrointestinal tract. Before antibiotics became widely available, phages were used to treat bacterial infections.

Used for decades

The so-called phage therapy was developed in the USA and the former USSR. Even as antibiotics were being developed in the western world, the former Soviet bloc continued its research on phage therapy. In the post-cold war era, research activities on phages were continued in Georgia where they are still being carried out today.

Phages have very high specificity to their host bacteria, a characteristic that presents potentially interesting applications for food and feed, as well as the biotech industry. Today, phages are used as additives to eliminate pathogenic organisms in food, as an instrument to detect bacteria, or as supplement in the Romer Labs SELECT™ media system, to reduce or even eliminate competitive bacterial flora, enabling target pathogenic bacteria species to grow to a detectable level.
They are more selective than antibiotics, and microbes do not develop any resistance to them.

Identifying cross-reactive bacteria

To identify phages, which can be used in selective enrichment media or other applications to inhibit or even kill competitive bacteria, the key question is: How can I even begin to find them?
The best way to start is by looking at food or feed samples, because these test materials contain bacteria which should be inhibited during enrichment. Bacteria strains that are distantly related, to the pathogen searched for, are not the target of the phages, but strains that are closely related to the target pathogen could cause false-positive results.

Transgenic? Not at all!

After the cross-reacting background bacteria are identified, the next step is to search for a phage that can act against it. Phages can be found everywhere, such as in raw sewage, surface water, food and the agricultural environment.

The easiest way to extract them, if it is a sold matrix, is centrifugation. In this way, the phages will stay in the supernatant, while other components such as bacteria will form a pellet at the bottom of the container. This supernatant contains a heterogeneous mixture of different phages.
Next the different phages are isolated and the bacterial host they infect will have to be determined. This could be done by the so-called “soft agar overly technique or by simple spotting”. In this technique, a lawn of bacteria is overlaid on a traditional agar plate and the phage supernatants are spotted on the bacterial lawn.

After an overnight incubation, the phages create plaques (or zones of clearing), which are visible to the naked eye. Plaques are zones where the phages have killed the bacteria by a lytic reaction. Now, the phage clones can be isolated from the agar, which means that they are all copies of the same phage strain.

Analytical techniques for the detection of mycotoxins continued to improve in the past. However, even when using accepted test procedures there is variability associated with each of the above mentioned steps. Studies by several scientists have shown that sampling usually is the largest source of variation associated with the mycotoxin test procedure [1, 2, 4, 5, 6]. For example nearly 90% of the error associated with aflatoxin testing can be attributed to sampling. As time and money are being spent for the analyses of mycotoxins, the extra time for proper sampling is crucial for replicable mycotoxin results.

Sampling must be monitored and proper techniques implemented. Sampling procedures must be written, reviewed and followed by everyone involved.

The high sampling error when testing for mycotoxins is due to two main factors: low concentration of mycotoxins in a given commodity (the "ppb-problem”) and the unequal distribution in the lot.

The ppb-problem

Despite extremely high levels of mycotoxins in some kernels, the overall concentration of mycotoxins in a lot of grain is usually very low. The unit of measurement is commonly "parts per billion” (ppb). To illustrate the meaning of these low levels, some examples are given in table 1. [3] Always remember: mycotoxins already affect human and animal health at these low concentrations!

1 ppb is…

• 1 part in 1.000.000.000 
• 1 second in 32 years
• 1 grain of sand in 22 kg
• 1 corn plant in 40.000 acres of corn
• 1 kernel of corn in 3.5 railcars

More and more food producers turn away from traditional allergen concentrations towards the concept of action levels. These action levels, as originally suggested with VITAL (Voluntary Incidental Trace Allergen Labelling) by the Australian Allergen Bureau, focus on the final intake by the allergic individual.

This concept takes into account the average serving size. Hence, the same allergen concentration has a different effect on the consumer in a pinch of spices than in a portion of pasta. 

Manufacturers are encouraged to assess the impact of allergen cross contamination in their products when considering detection limits to provide relevant precautionary labelling of allergens.

The hook effect does not pose a problem in day-to-day testing using the strips. In fact, it is only usually encountered when someone is trying to verify if the LFDs are working correctly by testing 100% of the allergenic food. By doing so, the amount of allergen present exceeds the finite amount of the colored labelling material, often colloidal gold or colored latex coupled to the detection antibody. 

The excess unlabelled allergen migrates along the membrane quicker than the heavier color-labelled allergen, saturating all the binding sites on the capture antibodies immobilised on the membrane surface. When the color-labelled allergen arrives, no binding sites remain, so it simply continues on to the wicking pad at the end of the test device. Since no binding sites were available, the color-labelled allergen cannot create the colored test line that would normally represent a positive result.

European Union

In the European Union strict rules and legislative limits defined by the European Commission have been set for all of the above mentioned toxins in certain food- and feedstuff to protect animals and humans.

Regulations in the European Union

Ever-present danger

Mycotoxins are naturally-occurring secondary fungal metabolites toxic to animals and humans. Mold fungi grow on the field and during storage. Found in almost all agricultural commodities worldwide, more than 380 mycotoxins have been identified and the toxicity of each substance varies greatly. The predetermined maximum permitted concentrations of various mycotoxins in vegetable raw materials such as grain, wheat, corn – to name just a few – have forced commodity producers to examine their samples carefully in an analytical laboratory to be sure about the quality of their products.

Gravimetric preparation

Frequently, a fungus that grows under optimal conditions – sufficiently warm temperatures, high humidity and a suitable substrate – can produce mycotoxins. In the lab, the story of a reference material begins with the attempt to adjust artificial growth conditions in order to obtain optimal mycotoxin yields. This includes the use of a suitable fungal genus – as every fungus produces its own characteristic pattern of metabolites that can number into the several hundreds. The maintenance of fungal strains for production is crucial. Their vitality and functionality are constantly being monitored, since this forms the basis of all activities for the reference material production processes. Molds are living organisms that might mutate over time, or even degenerate and result in decreasing mycotoxin yields. New metabolites may form after a certain storage period, which can also influence the isolation process immensely. Strains must be renewed regularly in order to counteract mutations, impurities or other undesirable characteristics.

The first step, fermentation, hinges on making the lab environment literally as tasty as possible for the fungus to promote its growth. The optimal media also vary from strain to strain, so components such as salts and minerals are provided as a source of nutrients. The mold is allowed to grow for a certain time – anywhere from a few days to a few weeks – during which time the fungus metabolizes its medium.

After completion of the fermentation and a careful control of the process the mycotoxin is extracted from the culture material using a suitable organic solvent. Depending on the molecular structure, these can be polar or non-polar organic solvents. During fermentation, molds mostly produce impurities in addition to the toxin of interest, e.g. other metabolites, colorings, oils, etc.

The resulting crude extract often contains many impurities. During isolation or purification, the mycotoxin is brought step-by-step closer to the target purity of >98% through various chromatographic and preparative applications with different selectivity.
Some toxins have favorable molecular structures, and can be crystallized from a supersaturated solution of polar or apolar organic solvents. This happens, for example, by cooling the solution, by evaporating the crystallization solvent or by mixing several solvents of different polarity. Other toxins may be rendered in crystalline, powdery form by freeze-drying. By crystallization the purity of the toxin is thereby increased again until the target purity is obtained.

Limitations to consider

Due to the high specificity of antibodies towards only one particular allergenic protein and technology related limitations, a separate kit has to be used for each allergen. Furthermore, the high degree of specificity to one allergen might lead to false negative results.
Food processing steps like heat treatment, the addition of acidic compounds or fermentation can modify the target protein structure. These modified allergens can lose their immunological properties and the antibody – target protein complex cannot be formed anymore. This leads to false negative results or reduced quantifications. Strip tests are inexpensive, very easy to use, do not require laboratory equipment, and give results usually in a few minutes. However, most strip tests are only qualitative and rely on antibodies as recognition elements. Therefore, they suffer from the same problems as ELISA tests with highly processed food.
In recent years, alternative analysis methods have been established to overcome at least some of the restrictions of immuno-based tests systems.

Detecting allergens with DNA

PCR (polymerase chain reaction) is a relatively fast and inexpensive method for identifying DNA. This technology, developed in the 1980s, has improved continuously since then. PCR has been used for many years in the fields of medical diagnostics, forensics, environmental monitoring, and the quantification of genetically modified organisms in food and feed. In the early 2000s PCR was applied for the first time to identify the DNA of common food allergens like hazelnut and peanut. Until now, PCR assays for most of the US “big eight” and the 14 EU food allergens have been published.
PCR amplifies small fragments of a target DNA until a sufficient number of copies are obtained for visualization or quantification. By multiplying the analytical target by a factor of 107 to 109, the few molecules of allergen DNA obtained might just be sufficient for the successful detection of allergenic ingredients. Initially developed as a qualitative method, PCR was later modified to become a tool for quantitative analysis by the application of different fluorescent generating dyes or probes. The fact that PCR detects the extremely stable DNA molecule might be an advantage when analyzing highly processed food. DNA tends to be unaffected even by extreme conditions and can therefore still be detected even when most of the proteins have already been degraded or modified in some way. Furthermore, PCR can be used for allergens like celery which cannot be detected by antibodies. Celery has to be labeled in the EU but until now, all attempts to produce reliable antibodies have failed due to the close relationship between celery and other plants like parsley, carrot, coriander or fennel.
Over the last decade, newer DNA detection techniques have been developed. All these so-called isothermal amplification methods are in some way related to the conventional PCR but can be performed almost without any instrumentation.
A simple heating block is used to amplify the target DNA and the subsequent visual detection is realized via fluorescent dyes. Isothermal amplification is usually faster than PCR and less prone to any co-isolated impurities and in many cases even more sensitive.

In this issue:

• Challenges in Allergen Testing: Spiking and Recoveries
• The Hook Effect - When a Negative is not a Negative
• A Look Beyond Immuno-Based Allergen Testing
• Allergen Thresholds are VITAL - The Relevance of Action Levels

Enjoy your reading!

Romer Labs announces improvements of the rapid on-site strip test for the detection of soy. The new AgraStrip® Soy can be applied to a variety of finished food products, as well as rinse water and environmental swab samples.

The new AgraStrip® Soy was developed to protect brands and consumers from accidental soy contaminations. It uses a new and improved monoclonal antibody which allows extremely low amounts of soy to be detected in a shorter period of time. The first incubation step is now reduced from 20 to only 5 minutes, leading to a total assay time of 11 minutes.

Furthermore, the new AgraStrip® Extraction Reagent for Processed Soy improves the recovery of processed soy proteins, which are often difficult to detect, and thereby helps to avoid false negative results.

Soy represents an important food allergen all over the world. It is among the top allergens in Europe, which require labelling according to EU Regulation No 1169/2011 and is on the list of major food allergens in the USA according to the food allergen labeling act (FALCPA). Labeling of soy is furthermore mandatory in Canada, Japan and Australia/ New Zealand, all of them following Codex Alimentarius recommendations.

Soy is increasingly used as an ingredient in food preparations. The ever-present risk of cross contaminations in food production facilities has therefore risen in recent years.

For additional information please contact allergens@romerlabs.com.

Calibrant choice matters

Internal standards can be chemically-related compounds such as derivatives (e.g. zearalanone for zearalenone) or similar compounds with identical behavior during the ionization process that differ only in terms of the mass of the atoms (stable isotopes). LC-MS/MS analyses rely on stable isotope dilution assays to overcome matrix effects by the addition of known amounts of stable isotope-labeled standards to the analyzed sample. Stable isotope labeling involves the use of non-radioactive isotopes like ²H, 13C or 15N to replace the naturally occurring atom. Using Deuterium (²H) to replace the naturally occurring 1H doubles the mass, which is the reason why deuterated labeled standards might show retention time shifts resulting in less accurate LC-MS/MS results.

• purity assessment of the raw material
• traceability back to national standards
• measurement uncertainty and its calculation
• a homogeneity study
• a long- and short-term stability study
• description of intended use

Certified reference materials are intended for the verification of in-house standards such as reference materials routinely used in the lab. They are used for the calibration of equipment especially in ISO 17025 accredited testing laboratories where traceability and high quality of results are of great importance.

1. Traceability

This is one issue every laboratory struggles with. An accredited laboratory is required to show that a result on one of its test reports can be traced back to international standard (SI) base units. In the case of a result stated in μg/kg (microgram per kilogram) obtained by HPLC (High Performance Liquid Chromatography) or LC-MS (liquid chromatography with mass spectrometry detection) this implies clear documentation. Both use a liquid standard for calibration, and in order to claim full traceability back to the SI base unit kilogram, auditors will want a certification report stating the full procedure of preparation and all measures taken by the supplier. (For more, see the box text on 'Traceability and Certified Reference Materials')

2. Measurement uncertainty

Under ISO 17025 requirements, the measurement uncertainty (mu) of every accredited method must be calculated and included in the test report. There are many ways to estimate or calculate measurement uncertainty and which way is accepted depends a lot on the preference of the national accreditation body. A simple and practical way for small laboratories to estimate measurement uncertainty is through the use of control charts. It is good laboratory practice to use a matrix-based control sample that ideally is naturally contaminated with or has been spiked with the analyte of interest. This sample is then added to each sequence run.
Results of the control samples are plotted on control charts that are used for long-term assessment and identification of trends for each method. The measurement uncertainty is derived from a two-sigma standard deviation of all results. In Europe, a valid approach is the “fitness for purpose” approach published in Commission Regulation (EC) No 401/2006 which details the methods of sampling and analysis for the official control of mycotoxin levels in foodstuffs. The following formula presents a way of calculating the maximum standard uncertainty:

How do I choose the right test kit?

So how do we ensure that the test kit produced is suitable for use with such a diverse and challenging range of samples? This is where sample validation comes in. The process involves adding a known amount of an allergen of interest to our matrix (spike) and then trying to get that allergen back out again (recovery).
An important thing to remember is that, as the name implies, immunoassays use biological components (antibodies) to achieve the detection of the allergenic proteins of interest. As with all biological systems, the kits are sensitive to extremes.
In the case of foods, the kits may not work as they should in the presence of strong acid or alkali, high salt, high fat, etc. Many of these extremes can be countered during the extraction process. Kits therefore use a buffered system to cope with changes in pH and the addition of the buffer to the sample helps reduce and dilute some of the other problems such as salt and fat.

Is my recovery acceptable?

When it comes to the recovery of a known amount of allergen from a sample matrix, what is deemed acceptable? Before answering this, we need to define where we are starting from. Is it an incurred sample or a spiked one?

Incurred samples are defined as samples in which a known amount of the food allergen has been incorporated during processing, mimicking as closely as possible the actual conditions under which the sample matrix would normally be manufactured.

The subject of incurred samples will be discussed in more depth in a subsequent issue of Spot On. In this article, I will concentrate on outlining a more accessible method of spiking a known amount of allergen into a matrix as received from the supplier or manufacturer and measuring its recovery.    

With regard to recovery, the guidance states that:

“Ideal percent recovery levels would range from 80 to 120%. Recovery levels are affected by both the efficiency of the extraction step and the ELISA procedure.

“With ELISA methods for food allergens, this level of recovery is not always possible, particularly when certain difficult matrixes are analysed. In addition, the recovery from incurred samples can be substantially different from those obtained using spiked samples.

"For this reason, recoveries between 50 and 150% will be considered acceptable so long as they can be shown to be consistent.”

The guidelines were published in 2010 by the Association of Analytical Communities (AOAC) with particular reference to quantitative ELISA (Enzyme Linked Immunosorbent Assay) methods. Many of the key points are also applicable to qualitative or semi-quantitative LFD (Lateral Flow Device) methods.

The “science” behind spiking 

When we receive or encounter a new food type that has not been tested before, we will undertake spike recovery validation to ensure it works as it should with our test kits. We will spike in at three different levels of allergen – low, medium and high – to cover the range of detection of the assay.

The low allergen spike will be close to the Lower Limit of Quantitation, LLOQ, of the ELISA (in this case the lowest value calibrator above 0 ppm) or close to the Limit of Detection, LOD, of a lateral flow device. The medium spike will be in the middle of the ELISA calibration curve, and the high spike will be at or near the Upper Limit of Quantitation, ULOQ (the highest ppm value calibrator). The sample is extracted and tested in accordance with the product insert supplied with the kit.

So for example, if we spike 5 ppm of almond into chocolate, we would expect to see a recovery of 4 ppm to 6ppm. If the result is outside of this range, then there are steps that can be taken to help improve the recovery. From experience, chocolate is one of the most challenging food matrices to test – it is full of tannins and other polyphenols which can bind to any allergenic protein that may be present and form insoluble complexes which are difficult to extract.

Such difficulties can be overcome by adding extra protein to the extraction buffer. The excess protein binds to the polyphenols and makes the allergens available for extraction. My protein of choice is fish gelatine, although other material such as milk powder can be used to improve the extraction efficiency from high polyphenol containing foods. If using milk powder, be careful not to contaminate your laboratory space, especially if you are carrying out milk allergen testing.

Lateral Flow Devices, or strips or dipsticks as they are sometimes referred to, can be validated for spike recovery in a similar way to an allergen ELISA test kit. The thing to be aware of when choosing a high spike level is that although LFDs are capable of detecting very high ppm levels, you can actually overload the device by adding too much allergen. This can occur in amounts greater than 1% of the allergenic food.

Maintaining quality and test precision

It may be necessary for a kit manufacturer to work closely with customers who routinely test challenging food matrixes. It is important to verify that the kit is working as it should and to the customer’s satisfaction. This can be achieved, as detailed above, by undertaking allergen spike recovery experiments into the problematic matrix.

In some cases it may be desirable to modify or change the standard kit method to meet the demands of the sample and/or the customer; this should always be undertaken with the guidance of the kit manufacture to ensure the quality and reproducibility of the test kit.

The major ergot fungus is Claviceps which produces sclerotia in several grass species with C. purpurea being the most commonly found species. However, C. fusiformis has produced ergot in pearl millet. C. paspali has been associated with problems in Dallis grass poisonings. Ergot does occur in sorghum and is caused by the organism Sphacelia sorghi. While other fungi are also capable of producing ergot alkaloid these are the major species that are producers of ergot in grain.

The entire life cycle of the organism Claviceps is quite complex but for simplicity, this organism and the other fungi mentioned above replace the developing ovaries of the developing seed with hard masses of fungal tissue called sclerotia (sometimes called "Ergots"). The sclerotia are brown to purple-black in color and contain the ergot alkaloids. The fungus gains entry into the host plant from ergots that have been in the soil. The infecting fungal elements are assisted by wind and splashing rain in gaining access to the host plant where the florets are invaded with subsequent development of sclerotia. The fungus uses nutrients from the plant for development of the ergots and biosynthesis of the ergot alkaloids. The ergots are harvested with the grain and if not eliminated by screening or some other process they can end up in feed or food made from the contaminated grain. Ergot is not a storage initiated problem but the ergots can be present in stored grains resulting from harvesting of ergots along with the grain.

Toxicity

Ergotism is one of the oldest known mycotoxicoses with ancient records of its occurrence. One of the most publicized events was the human epidemics produced by ergot in the Middle Ages known as St. Anthony’s fire with symptoms of gangrene, central nervous and gastrointestinal effects. Animals are affected similarly to what has been observed in humans. In swine agalactia has been attributed to ergot alkaloids. The loss of ears and other appendages is a common effect of ergot in animals. Two types of ergotism have been described; gangrenous and convulsive.
The differences may be due to the different kinds of alkaloids present in the ergot as variations in amount and kinds of alkaloids can occur in the ergot (sclerotia). Recent outbreaks have occurred in Ethiopia (1978) where gangrene and loss of limbs occurred and in India (1975) where the effects were more of the nervous type symptoms of giddiness, drowsiness, nausea and vomiting.
Ergometrine was the alkaloid found in the Ethiopian sclerotia and in India the clavine alkaloids agroclavine, elymoclavine, chanoclavine, penniclavine and setoclavine were found. The ergots produced in these two outbreaks were caused by different species of Claviceps. Because some of the ergot alkaloids are vasoconstrictive and have other beneficial pharmacological properties, they have been used therapeutically. In the United States, most of the widely grown tall fescue posesses an endophytic fungus called Neotyphodium coenophialum. This endophyte produces ergovaline, an ergopeptine, which can, if consumed levels are sufficient, produce ergot-like toxicosis in animals grazed on pastures containing the fescue grass (CAST, 2003).

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Fusarium graminearum is the principal DON-producing fungus in grains but Fusarium culmorum is often involved as well especially in certain geographical areas of the world.
Corn and small grains such as wheat, oats and barley are the major crops affected. The organism survives on old infected residue left on the field from the previous season, providing an inoculum source for the new crop. The organism does well in cool, moist conditions with contamination of the crop occurring when spores (conidia) of the organism are windblown to the silks of the corn and in small grain to the anthers (male portions of the flower) which emerge outside the floret during what is called anthesis. The fungus penetrates the host ear or floret and produces the disease and DON. In wheat, it appears that DON production is necessary for the organism to produce the disease.

In corn the “ear rot” produced by F. graminearum may appear as purple to pink stained kernels with visible pink mold growth over the affected areas of the ear. Sometimes the growth of the fungus will appear through the husk as pink growth and staining and the entire ear will be affected. Wheat heads may appear prematurely ripe and the ripe kernels will have a blanched appearance (tombstone kernels) and may have pink stain present from the fungus.
This is not quite as evident in barley kernels, but oat kernels will have pink staining as well. The disease in wheat is called head blight, scab or pink scab.

Storage under good conditions (<14% moisture) will minimize further elaboration of the toxin by these toxigenic fungi. Conditions favorable to mold growth should be avoided as well as insect pests and moisture. Generally, storage is not considered a problem for DON contaminated wheat and corn that has matured and been stored at moisture percentages below 14%.

Toxicity

Swine are the animals most usually affected by this toxin and exhibit reduced intake of contaminated grain, if they do eat it, they may vomit. Levels above 1 ppm are considered potentially harmful to these animals. Pet foods prepared with wheat contaminated with this toxin have been involved in acute toxicities. DON is a known immunosuppressant and may cause kidney problems. Humans are thought to exhibit a similar vomition syndrome when consuming DON-contaminated grain. DON does not appear to carry over into tissues or fluids of animals consuming toxic levels. Baking and malting are adversely affected by contaminated wheat and barley.

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The major species of fungus responsible for producing this mycotoxin is Fusarium graminearum. In some of the older literature this organism is called F. roseum. Grain infected with this organism often will have a pink color because of a pigment that may be simultaneously produced with the zearalenone.

Most often the compound is found in corn, however, it is found also in other important crops such as wheat, barley, sorghum and rye throughout various countries of the world. In wheat the conditions for the occurrence of zearalenone would be essentially the same as for the occurrence of deoxynivalenol as the organism gains entry into the host plant in the same manner. Generally, the Fusarium species grow in moist cool conditions and similarly invade crops under these more favorable conditions. As noted above, the same organism produces both of these compounds. This same organism is capable of producing both compounds in corn. The finding of aflatoxin co-occurring with zearalenone and deoxynivalenol would imply that infection was established by two different fungi, Aspergillus flavus in the case of aflatoxin and F. graminearum in the case of the latter two mycotoxins. In wheat, sorghum and corn, it is well-established that zearalenone occurs in preharvest grain but in other commodities the surveys are insufficient to determine if the zearalenone occurred pre- or postharvest.
Variations in the incidence of zearalenone occur with different crop years, cereal crop and perhaps geographical areas.

As with other fungi, to avoid growth of F. graminearum in grains during storage the moisture level should be <14%. Perhaps, zearalenone can be produced in relatively cool conditions compared to some other mycotoxins but it is likely that most grains mentioned above can become contaminated with zearalenone during storage and levels that were present in the grain preharvest may increase if the grain is not sufficiently dried and stored.

Toxicity

The most notable effect of zearalenone is that it causes precocious development of mammae and other estrogenic effects in young gilts as well as prepucial enlargement in young barrows.
Swine appear to be the animals most significantly affected and are considerably more sensitive than rodents. Weak piglets and small litter size have been attributed to the effects of zearalenone when fed to sows during gestation. Levels of 0.5 to 1.0 ppm of dietary zearalenone have been associated with the latter effects while hyperestrogenism in swine was associated with dietary levels of 1.5 to 5.0 ppm. Twelve ppm zearalenone was found in sorghum that was involved in bovine abortion. Zearalenone appears to bind to estrogen receptors and can result in hormonal changes. Zearalenone does not appear to be involved in mortalities because of its high oral LD50. Interestingly, zearalenone or its metabolites have been suspected to cause precocious pubertal changes in young children in Puerto Rico. The occurrence of this phenomenon in other countries needs confirmation as to the causation. Of note is that the metabolite of zearalenone known as α-zearalenol, is actually more estrogenic than is the parent compound (Richardson et al., 1985).

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There are two major producers, Fusarium verticillioides and Fusarium proliferatum, however other closely related species are capable of producing these toxins but are less important in grains. All strains are considerably variable in toxin producing ability.

Corn is the major commodity affected by this group of toxins, although a few occurrences have been reported in rice and sorghum. Fumonisins have been reported in barley but this awaits confirmation in further samples. The exact conditions for disease are not known but drought stress followed by warm, wet weather during flowering seems to be important.
Insect damage to maturing corn ears allows for environmentally present strains of the organism to enter the ear and kernels. Wet weather just prior to harvest may exacerbate the contamination with fumonisins in corn. However, the organism is present in virtually every seed and is present in the corn plant throughout its growth and therefore is present in the ears and kernels. Sometimes there is considerable amount of fumonisins present in symptomless kernels of corn.

As mentioned, some corn kernels may have no evidence of infection as the organism is internal and capable of toxin production. Other corn may demonstrate “pink kernel rot” with a closely adhering organism on the kernels. Sometimes the kernels will be covered with white fungal growth instead of pink. Those kernels with insect or bird damage or broken kernels will often contain the highest levels of toxin. Thus, corn screenings will contain the highest levels of toxins and are often found to be the cause of animal toxicoses. In rice, fumonisins have been found to be present where sheath rot disease is present.

Grains should be harvested without kernel damage, screened and dried to a level of moisture suitable for storage (<14%). Conditions favorable to mold growth likely will cause the further formation of fumonisins in storage. Grains should be kept free of additional moisture or insects. At this time, not much information is available for storage of fumonisin contaminated corn, but cleaning can considerably reduce the concentration levels in corn.

Toxicity

A major disease of horses that includes a softening of the white matter in the brains (leukoencephalomalacia) is caused by the fumonisins (Marasas et al., 1988). Swine lung edema is also produced by the fumonisins (Harrison et al., 1990; Ross et al., 1990). Other diseases such as liver disease and tumors have been noted in rodents (Voss et al., 2001). The fumonisins are tumor promoters and one study demonstrated total carcinogenesis, which has been confirmed in a two year study by the FDA. It is not known whether the fumonisins are truly involved in causing esophageal tumors in certain human populations. Fumonisins remain as suspect entities in neural tube defects in humans in certain regions of the world and is a current area of investigation (Marasas et al., 2004). Regardless of the other effects on animals, the liver is often involved in the toxicity. There is no carryover of fumonisins into milk in cattle and there appears to be little absorption of toxin in tissues but what little is rapidly taken up is rapidly eliminated.

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The major fungus producing aflatoxins is Aspergillus flavus. However, another fungus, Aspergillus parasiticus and a few other minor species of Aspergillus can also produce these toxins. Aspergillus parasiticus is especially important in peanuts. Not all strains of a given species are capable of aflatoxin production.

When grain such as corn is growing and there is warm ambient temperature (day >32°C; night >24°C), especially noted during drought conditions, the grain becomes more susceptible to aflatoxin formation. These stressful conditions are more prevalent in hot and dry environments (e.g. the southern United States, but can also occur in the Midwest (Corn Belt)). The organism survives in spores (conidia), which are carried by wind or insects to the growing crop. Any condition that interferes with the integrity of the seed coat allows the organism to gain entry into individual kernels. Insects such as sap beetles carry the organism into the developing ears especially those damaged by corn earworms and European corn borers. The two latter insects can carry the organism into plants as well. Corn, cottonseed, peanuts and tree nuts are the main crops affected.

Yellow-green spore masses may be visible at sites of kernel damage or may follow an insect feeding path. If heavily damaged kernels are cracked open by hand and examined under a black light (long wave, 365 nm) they may fluoresce bright greenish-yellow (BGYF). This fluorescence is due to a kojic acid derivative formed by the organism that produces aflatoxin and therefore provides only a “presumptive” indication of the presence of aflatoxin and is not to be used as a positive test for aflatoxin. Individual kernels of corn may contain as high as 400,000 ppb (μg/kg) of aflatoxin, therefore, sampling is very important in analysis for levels of contamination in bulk grain lots.

Grains stored under high moisture/humidity (>14%) at warm temperatures (>20 ºC) or/ and inadequately dried can potentially become contaminated. Grains must be kept dry, free of damage and free of insects; these conditions can result in mold “hot spots”. Initial growth of fungi in grains can form sufficient moisture from metabolism to allow for further growth and mycotoxin formation.

Toxicity

Aflatoxins can cause liver disease in animals, they are also carcinogenic with aflatoxin B1 being the most potent carcinogen (WHO, 2002). Susceptibility varies with breed, species, age, dose, length of exposure and nutritional status. Aflatoxins may cause decreased production (milk, eggs, weight gains, etc.), are immunosuppressive, carcinogenic and mutagenic. Aflatoxins can be present in milk, meat, or eggs if consumed levels are sufficient. Aflatoxin B1 is a human carcinogen and may play a role in the etiology of human liver cancer as speculated by Williams et al. (2004). Ammoniation and some adsorbents will reduce or eliminate the effects of aflatoxins, but can only be applied for animal feedingstuff and in certain countries or within specific states.

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The name of the compound came from the organism Penicillium citrinum from which this mycotoxin was first isolated. Since that time the compound has been shown to be produced by several other Penicillium species and also by a select few species of Aspergillus.
Citrinin has been isolated from its natural occurrence in cereal grains such as wheat, barley, oats, rice and corn. Probably the major characteristic of its occurrence is that it often co-occurs with ochratoxin A in the cereals and most isolates of fungi that produce citrinin also produce ochratoxin A. The conditions under which citrinin occurs in the field are presumed to be similar to that for ochratoxin and levels have been found in cereal grains as high as 80 ppm.
Unfortunately, little is known regarding the field occurrence of either ochratoxin or citrinin and therefore they are considered as storage problems in grains, although ochratoxin is known to occur in certain crops at harvest such as grapes but this is usually the result of production by some of the “black” aspergilli such as A. carbonarius.

Again, grains with any visible presence of mold should be suspect and especially if the fungi are identified and found to be species that are capable of citrinin production. Musty smelling grain should be suspect of any mycotoxins but only testing for the specific mycotoxins can be absolute proof.

It is likely that most of the citrinin in grains occurs during storage, at least until we gain further insight into the field occurrence. Therefore, grain should be adequately stored, kept dry and at <14% moisture and insects damage should be avoided or kept to a minimum.
Maintaining the integrity of the seed coat and avoiding favorable moisture for fungal growth
can keep mycotoxins from forming during storage.

Toxicity

Toxicity concerns for citrinin appear to be aimed toward poultry with the effects primarily on the kidney of these species. Regarding its relative toxicity, citrinin appears to be considerably less toxic to poultry than oosporein or ochratoxin A, two other important nephrotoxic mycotoxins.
High levels of citrinin may affect the liver in addition to the kidney. Citrinin produces necrosis of the distal tubule epithelium in the kidney and is a pH dependent tautomer. As citrinin it is neutral but when it is excreted in the alkaline urine it becomes a phenol which is rapidly reabsorbed by the kidney where it tautomerizes back to citrinin. In poultry common symptoms of toxicity by citrinin includes increased water consumption and diarrhea. These symptoms have been caused by levels as low as 130 and 260 ppm dietary citrinin. The diarrhea appears to be caused by the increased urine excretion due to altered function and degenerative processes of the renal tubules and not due to gastrointestinal disturbances. It is highly likely that when citrinin and ochratoxin occur in combination in grain and then fed to animals, there can be an exacerbation of the effects because of the similarity of the effects of both toxins. Any search for either toxin should include the other as well.

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Fusarium sporotrichioides is the principle fungus responsible for the production of T-2 toxin. Some strains of this fungus also produce DAS and HT-2 toxin, however DAS is the least common of the three toxins. Corn, wheat, barley, oats, rice, rye and other crops have been reported to contain the T-2 toxin. Natural occurrence has been reported in Asia, Africa, South America, Europe and North America. Natural levels range from near zero to 10 ppm with a few exceptions showing levels of 15-40 ppm. The toxin production is greatest with increased humidity and temperatures of 6-24°C. Storage of commodities below 14% moisture will minimize further fungal growth and production of the T-2 toxin. In addition grains kept free of insect damage and dried prior to storage may decrease the effects of further contamination.
Poultry feed and certain other food products are most commonly contaminated. In the United States T-2 toxin is infrequently found and, if found, likely results from inadequate storage of products.

The Fusarium mold on corn primarily appears white, in some instances the mold can also appear pink to reddish, often beginning at the tip of the ear. Occasional blue-black specks will be found on the husk and ear shank to indicate mold contamination.

Toxicity

The major attribute of the T-2 toxin and other trichothecenes is that they inhibit protein synthesis which is followed by a secondary disruption of DNA and RNA synthesis (Ueno, 1984). It affects the actively dividing cells such as those lining the gastrointestinal tract, skin, lymphoid and erythroid cells. It can decrease antibody levels, immunoglobulins and certain other humoral factors. The effects include weight loss or poor weight gain, bloody diarrhea, dermal necrosis or beak lesions, hemorrhage and decreased production (weight gain, eggs, milk, etc.). The Type-A trichothecenes are more toxic to poultry species than the Type-B trichothecenes. Yellow caseous plaques, occurring at the margin of the beak, mucosa of the hard palate, angle of the mouth and tongue, characterize typical oral lesions. Severity of the lesions will increase with prolonged feeding and increased dietary levels. Beak or oral lesions can occur at dietary levels of 4 mg/kg after 1 week, 0.4 mg/kg after 7 weeks, and with 1-4 mg/kg, beak or oral lesions occurred in addition to decreased weight and feed intake after 3 weeks (Richard, 2007). There is also a synergism between aflatoxin and T-2 toxin discussed (Huff et al., 1988).

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Patulin is produced by several fungi, most of which belong to the genera Aspergillus and Penicillium. Patulin actually gets its name from the mold Penicillium patulinum. Since 1986, additional genera have been added to the potential list of patulin producers.
Patulin contamination is primarily associated with damaged and rotting fruits and fruit juices made from poor quality fruits. Patulin producing molds are found on such fruits as peaches, pears, grapes and especially apples. Recent reports indicate that patulin can be found in some vegetables. By far the most common site of occurrence of patulin is in apples.
Patulin is particularly associated with apples exhibiting “brown rot” or other rotting characteristics. Any fruit with visible signs of rotting, decay or mold growth can be suspect and containing patulin (Frank, 1977).

Fruits stored under conditions that promote bruising and rotting increase the probability of patulin formation. Patulin is very stable in apple juice and grape juice. In many foodstuffs, sucrose actually protects patulin from degradation during heat treatment.

Toxicity

While patulin may be an important mycotoxin in problems associated with silage, confirmation of such has not be established but should be considered when investigating silage problems in especially dairy cattle. Initial studies of patulin indicated that it had antibiotic properties against certain bacteria. Further studies indicated, however, that the patulin was too toxic for use in humans. While some animal studies suggest a carcinogenic potential of patulin (Becci et al., 1981) by IARC. Symptoms of patulin include hemorrhaging in the digestive tract in cattle.

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The primary producers of ochratoxin are Aspergillus ochraceus and Penicillium verrucosum. Other fungi such as Aspergillus niger and Aspergillus carbonarius may be important in some commodities or geographic areas.

Little is known of the conditions necessary for involvement of the producing fungi in grains and other commodities during development in the field. Therefore, ochratoxin has been regarded as being produced most likely in storage under conditions that would favor mold growth (adequate moisture/humidity and temperature).

Because of the diverse commodities on which the producing organisms and ochratoxin are found, the description of such is difficult. However, visible mold from the major species producing ochratoxin which vary from yellowish tan with A. ochraceus to blue-green with Penicillium species and black with A. niger or A. carbonarius. Visible mold may not be present for ochratoxin to occur in grains and other commodities. Grain that has a “musty” odor should be suspect for mycotoxins and ochratoxin would be included in the suspect list. Any time the integrity of the seed coat of grain has been compromised such as stress cracks and broken kernels, there is potential for invasion by the ochratoxin-producing fungi. Appropriate sampling for analysis is important as “hot spots” can occur in storage for the growth and ochratoxin production by these fungi.

As mentioned above, this is likely the major way that commodities become contaminated with ochratoxin. Grains stored under high moisture/humidity (>14%) at warm temperatures (>20°C) and/or inadequately dried potentially can become contaminated. Damage to the grain by mechanical means, physical means or insects can provide a portal of entry for the fungus. Initial growth of fungi in grains can form sufficient moisture from metabolism to allow for further growth and mycotoxin formation.

Toxicity

Ochratoxin is primarily a kidney toxin but if the concentration is sufficiently high there can be damage to the liver as well (Pfohl-Leszkowic and Manderville, 2007). Ochratoxin is a carcinogen in rats and mice and is suspect as the causative agent of a human disease, Balkan Endemic Nephropathy, that affects the kidneys and often tumors are associated with the disease (Wolstenholme et al., 1967). The toxin may be still present in products made from grain and the human population is exposed in this manner. A significant impact of ochratoxin is that it occurs in such a wide variety of commodities such as raisins, barley, soy products and coffee in amounts that may be relatively low. However, the levels may accumulate in the body of either humans or animals consuming contaminated food because ochratoxin is often not rapidly removed from the body and significant amounts may accumulate in the blood and other selected tissues. Ochratoxin produces necrosis of the proximal tubule epithelium and then is released whereby it is reabsorbed by albumin and continues to be circulated via the bloodstream. The awareness of the occurrence of ochratoxin in this wide variety of commodities has been possible through increased sensitivity of the methods for the analysis of ochratoxin. Of significance is the finding of high levels of ochratoxin in house dust (Richard et al., 1999) and could be an important entity in inhalation toxicology in humans and other animals as this compound apparently is absorbed efficiently by respiratory epithelium.

Check out our Ergot Alkaloid Solutions

• Traceability and Certified Reference Materials
• Overcoming LC-MS/MS Matrix Effects for Maximum Reliability
• Creating Liquid Mycotoxin Calibrants: A Behind-the-Scenes Look

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projects across the globe

Charity is its own reward.

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The new website provides strengthened visual appeal while preserving the content-rich structure and the following new features:

• ERBER Group and its divisions at a glance
• Large pictures and attractive visuals offer a modern look that combines both usability and appeal
• An extended Human Resources section with more information for applicants
• Enhanced navigation
• New and improved search feature
• Major improvements in the News & Media section such as filters and a dedicated search allow users quick and easy access to news, press releases, videos, pictures and more.

The new ERBER Group website is now available in English and German.

Have a look at the new website here: http://www.erber-group.net

Situated about 75 kilometers west of Vienna, the township of Getzersdorf will house the new headquarters of the Erber AG. A groundbreaking ceremony on 13 Nov, 2013 marked the start of construction which is estimated to cost in the range of double-digit million euros.