Global Leaders in Food Safety Testing

 

Food and Beverage News

EW GROUP announces the acquisition of Hygiena from
Warburg Pincus to form a leading food safety, veterinary
and 
environmental diagnostic solutions company

February 16, 2021 – Visbek, Germany / Camarillo, CA, USA – EW GROUP, a German strategic holding company in the field of animal breeding, health, nutrition and diagnostics, announced today the acquisition of Hygiena, a leader in food safety and environmental testing solutions. The terms of the transaction have not been disclosed. The transaction is expected to close in March 2021.

Hygiena, headquartered in Camarillo, California, USA, with 9 locations around the world, develops, manufactures and distributes food safety and environmental diagnostic solutions. The products are sold in over 100 countries to more than 10,000 customers. For two decades, Hygiena has been committed to providing accurate and easy-to-use-diagnostic tests, supported by the most knowledgeable technical service teams in the industry.

“We have always been committed to providing the best-in-class diagnostics and customer support around the world. This new partnership with EW GROUP will accelerate our growth, enhance our global capabilities, and expand our portfolio of products for our customers,” said Steven Nason, CEO of Hygiena. “I couldn’t have imagined a better outcome for Hygiena and our Hygiena team. We are so excited to continue our mission within EW GROUP and look forward to joining forces with the BioChek and Biotecon teams. Warburg Pincus has been an amazing partner in our journey over the past four and a half years. I would like to thank them for their close partnership, invaluable contribution and strategic insight.”

The newly formed group of companies, under the Hygiena umbrella, will include BioChek, a global veterinary diagnostic company, as well as Biotecon, an innovator in PCR, GMO, ID and environmental diagnostics. Both companies are subsidiaries of the EW GROUP, expanding Hygiena’s food safety portfolio with attractive molecular diagnostic capabilities, sample preparation as well as the veterinary diagnostic field.

“We are extremely excited about welcoming Hygiena to EW GROUP. Due to the outstanding leadership of Steve Nason and his team, Hygiena has become a leading player in the food and environmental testing space,” commented Jan and Dirk Wesjohann, both Managing Directors at EW GROUP. “We are convinced that the combination of Hygiena with our existing diagnostic activities will create a basis for substantial future growth.”

Thomas Struckmeyer, CEO of BioChek and Biotecon, is also enthusiastic: “With this acquisition and through the synergetic combination with our existing diagnostics businesses, we will create a leading player in food and veterinary diagnostics, providing a true ‘One Health’ approach from ‘Farm to Fork’ to the benefit of our global customer base.”

As part of the partnership, EW GROUP and Hygiena are committed, based on the EW GROUP principles, to invest in new technologies, R&D and international structures. Technical expertise will be leveraged amongst the companies to develop new products in diagnostics, accelerate development and further improve data interpretation and management software capabilities.

"We are excited for Hygiena’s next chapter of growth and know that they will continue to thrive in combination with EW GROUP, a partner that shares the same values, ensures a positive future for the entire Hygiena team and lays the foundation for an excellent outlook for future business development," adds Stephanie Geveda of Warburg Pincus.

Houlihan Lokey and Citi served as financial advisors and Cleary Gottlieb Steen & Hamilton LLP served as legal advisor to Hygiena. Sidley Austin LLP and Moulton | Moore | Stella LLP acted as legal counsel for EW GROUP.

 

About Hygiena

Hygiena is a leader in rapid diagnostic solutions in the food & beverage, healthcare, pharmaceutical, water and other hygiene-focused end-markets. Our mission is focused on protecting people and products by delivering technologies that promote hygiene, sanitation and product safety. For more information, please visit hygiena.com.

 

About EW Group

EW GROUP is a strategic holding company based in Germany. The activities of EW GROUP are comprised of the business areas of poultry and aqua breeding, as well as animal health, nutrition and diagnostics (BioChek & Biotecon). EW GROUP operates 165 subsidiaries in 45 countries worldwide, employing over 15,000 team members. For more information about EW GROUP's diagnostic business, please visit biochek.com and bc-diagnostics.com.

 

About Warburg Pincus

Warburg Pincus LLC is a leading global private equity firm focused on growth investing. The firm has more than $58 billion in private equity assets under management. The firm’s active portfolio of more than 195 companies is highly diversified by stage, sector, and geography. Warburg Pincus is an experienced partner to management teams seeking to build durable companies with sustainable value. Founded in 1966, Warburg Pincus has raised 19 private equity funds, which have invested more than $89 billion in over 920 companies in more than 40 countries. The firm is headquartered in New York with offices in Amsterdam, Beijing, Berlin, Hong Kong, Houston, London, Luxembourg, Mumbai, Mauritius, San Francisco, São Paulo, Shanghai, and Singapore. For more information please visit www.warburgpincus.com..

BAX® SYSTEM REAL-TIME SALMONELLA PCR ASSAY
FIRST TO RECEIVE 
AOAC-RI APPROVAL
FOR SALMONELLA QUANTITATION

Quantitative assay for Salmonella means easy implementation of
targeted intervention processes and assessments of consumer risk in final products

  

CAMARILLO, Calif. (27 January 2021)— Hygiena, a leader in food safety testing, announces that the new quantification application (SalQuant™) of the BAX® System Real-Time (RT) PCR Assay for Salmonella has now received AOAC-RI Performance Tested MethodSM approval (certification #081201, an extension of the original BAX RT Salmonella PCR Assay). In addition to knowing if Salmonella is present, this test can now accurately quantify Salmonella levels from each sample when used with the BAX® System Q7.

 

For the first time ever, there is a rapid method that can provide quantitative data on contamination levels by performing RT-PCR on comminuted chicken and turkey collected from a food production facility. After only 8 hours of enrichment, samples are analyzed using the BAX® System RT PCR Assay for Saålmonella on the BAX® System Q7 instrument. The resulting cycle threshold (CT) values for positive samples is utilized to quantify the number of colony-forming units (CFUs) present in the sample. No additional kits or components are required, only the BAX System RT PCR Assay for Salmonella (KIT2012).

 

 This allows the collection of quantitative, numeric data on contamination levels that is location- or matrix-specific, more accurate and precise, and less laborious than MPN. By combining the power of real-time PCR, the BAX System RT Assay for Salmonella, and available protocols for multiple sampling locations throughout poultry production, processors can now quantify Salmonella from the farm to final product to improve and verify sanitation and antimicrobial intervention processes, to meet more stringent regulatory and quality standards, and protect consumers by knowing the risk a positive sample could pose. Processors can more quickly and confidently respond to increasing Salmonella contamination issues, allowing them to better focus their sanitation and antimicrobial interventions to root causes, saving money that otherwise would be used for wider interventions.

 

  “We are so excited to offer a quantitative application for Salmonella testing. This application of our RT Salmonella assay will dramatically improve the understanding of bacterial loads throughout the poultry production facilities, meaning more confidence in product release related to consumer risk,” said April Englishbey, PhD., product manager at Hygiena. “No more destruction or unnecessary diversions of Salmonella positive final products that pose low risk to consumers. This accreditation has paved the way not only for the poultry industry, but for the use of SalQuant™ in beef and pork industries to provided tools for data-drive decision making about Salmonella”. 

 

ABOUT HYGIENA 

Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, healthcare, hospitality, pharmaceuticals, and personal care. Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based pathogen detection and characterization systems, allergen tests, mycotoxin tests, environmental collection devices, and more. Hygiena is committed to the mission of providing customers with high-quality innovative technologies that are easy-to-use and reliable, backed by excellent customer service and support. Headquartered in Camarillo, California with offices in Wilmington, Delaware, Mexico, Spain, Canada, the United Kingdom and China, and over 80 distributors in more than 100 countries worldwide, Hygiena products span the globe. www.hygiena.com.  

Brexit update

With the Brexit deal signed by the EU and the British government, the Hygiena team is working hard to put all the steps in place to minimize any potential impact on deliveries.

  1. We are working closely with our logistics partners, DHL, FEDEX and DPD to ensure minimum disruption from our warehouse in the UK and exploring all freight options, including supporting our customers (importer of record) with customs clearance and increased air freight shipments. In addition, Hygiena has conducted stability studies  to confirm that our products are resistant to temperature conditions found with potential extended shipping times.
  2. If you utilize your own courier service, please contact them to determine any other recommendations they may have.
  3. You will continue to be declared as the importer of record on all shipments.
  4. Sales to you (EU customers) would be zero-rated for VAT as an export.
  5. Import VAT will apply to products imported into the European Union, which should be fully refundable through your local VAT return. You are advised to consult with your finance department regarding VAT issues and claiming back local VAT charges as per country regulations.
  6. We are no longer able to ship to EU customers under DDP terms. All previous DDP shipments are now changed to DAP.
  7. Under the Brexit deal, import duties do not apply to diagnostic reagents, test kits, and instruments, so there would be no additional associated cost with many of Hygiena products.
  8. To move your shipment from the UK to any EU country, you will require an EORI (Economic Operator Registration Identification) number, irrespective of the mode of transport being used. EORI is used for customs declarations of all goods entering or exiting the EU. It is important to provide your EORI number with your Purchase Order. Without an EORI number you can't legally import goods from the UK to the EU and such shipments can end up with increased costs (such as storage fees) and delivery delays.

We would like to thank you again for your support and co-operation during these challenging times. If you have any additional questions, please let your local sales manager know, or contact our customer service at This email address is being protected from spambots. You need JavaScript enabled to view it..

 Ecolab® Partners with Hygiena™ and Delivers Food Safety Solutions to the Food and Beverage Industry 

 With the partnership, Ecolab will sell ATP environmental monitoring, Allergen product lines and Rapid Microbial Screening solutions to North American Customers 

St. Paul, Minnesota (November 18, 2020)— Ecolab Food and Beverage North America announces its partnership with Hygiena, LLC, a leader in rapid food safety and environmental diagnostic testing technology. The partnership gives the food and beverage industry access to a new Hygiene Monitoring Program, creating an offering to help optimize Food Safety programs. 

“Ecolab Food & Beverage North America strategically partnered with Hygiena to help advance our customers’ hygiene monitoring and food safety programs. Our relationship brings together Hygiena’s game-changing EnSURE™ Touch luminometer, intelligent and reliable technology with a universal focus on service to offer our customers a digital, scalable, long-term solution,” said Nick Alfano, executive vice president and general manager for Ecolab Global Food & Beverage. 

Ecolab Food and Beverage North America will distribute and service a range of Hygiena’s products used by food and beverage customers, including the new EnSURE™ Touch ATP system, which uses the energy-containing component found in all cells to identify potential contamination. The digital cloud-based technology offers large customers multi-location supply chain monitoring, audit and risk management, and helps with recall prevention. 

“Now more than ever it is critical that our customers have access to advanced technology in support of achieving their food safety goals. Hygiena’s breadth of offerings, proven reliability and cloud-based software will give our customers visibility to multi-site cleaning performance, helping to redefine how our customers validate cleaning performance,” said Ann Gent, senior vice president and general manager for Ecolab Food and Beverage North America. 

“We are excited to welcome Ecolab as a distributor of Hygiena solutions, expanding availability of food safety and quality assurance products throughout the United States and Canada,” said Ed Luterbach, chief commercial officer for Hygiena. “Ecolab is a respected leader in industrial hygiene products and services and we are delighted to partner with them.” 

Hygiena solutions are now available through Ecolab Food and Beverage North America. 

Learn more at www.ecolab.com/hygiena

 

ABOUT ECOLAB 

A trusted partner at nearly three million commercial customer locations, Ecolab (ECL) is the global leader in water, hygiene and infection prevention solutions and services. With annual sales of $13 billion and more than 45,000 associates, Ecolab delivers comprehensive solutions, data-driven insights and personalized service to advance food safety, maintain clean and safe environments, optimize water and energy use, and improve operational efficiencies and sustainability for customers in the food, healthcare, hospitality and industrial markets in more than 170 countries around the world. www.ecolab.com

Follow us on Twitter @ecolab, Facebook at facebook.com/ecolab, LinkedIn at Ecolab or Instagram at Ecolab Inc.

 

ABOUT HYGIENA

Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, healthcare, hospitality, pharmaceuticals, and personal care. Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based pathogen detection and characterization systems, microbial characterization systems, allergen tests, environmental collection devices, and more. Hygiena is committed to the mission of providing customers with high-quality innovative technologies that are easy-to-use and reliable, backed by excellent customer service and support. Headquartered in Camarillo, California with offices in Wilmington, Delaware; Santa Ana, California; Mexico; Canada; United Kingdom; Spain, and China, and over 80 distributors in more than 100 countries worldwide, Hygiena products span the globe. www.hygiena.com.

HYGIENA ADDS SPECIFIC PEANUT TEST TO THE ALERTOX RANGE

 

CAMARILLO, Calif. (09 November 2020)— Hygiena, a global leader in food safety testing, is excited to launch a new addition to its rapid allergen testing line, AlerTox® Sticks Peanut. This rapid test is designed for the detection of peanut antigen by the food processing industry in their food, kitchen, and production facilities. Allergic reactions to peanut can range from mild irritation to life-threatening conditions, and peanut residue can be found in a wide variety of foods. Therefore, preventing cross-contamination during food processing is vitally important as it gives consumers reassurance of food quality and safety.

Hygiena’s new and improved peanut allergen test provides a simple and effective way to monitor the risk from peanut residue. This lateral flow device has high sensitivity with a wide dynamic range of detection from 1 to 10,000 ppm of peanut protein in food samples and no interference from other food components. It is validated for products, liquids and surface analysis.

The test specifically identifies peanut antigen, and does not detect the antigens of cereals, seeds, milk, cocoa, other legumes or tree nuts including pecan, walnut, hazelnut, almond, macadamia, pistachio, cashew, brazil nut, chestnut, pine nut and coconut.

“Since peanut residue can be found in a wide variety of foods, this test will allow users to detect as low as 1 ppm of peanut in 10 min with minimal sample preparation. It even has the ability to detect roasted peanut particulates,” states Charles McGuill, Product Manager at Hygiena. “Hygiena is proud to be a leader in providing simple, effective testing for the Food Safety Industry.”

This product represents a cost effective and rapid solution as the procedure only takes a few minutes and there is no equipment required as all additional elements are included in the 10-test kit. The test can be used for incoming ingredients, finished products or surfaces. It is validated in a wide range of products such as meat, fish, sausage, pate, bread, cookies, cakes, flours, milk powder, spices and stainless steel surfaces. For quantitation of peanut antigen, additional testing can be done with the AlerTox® ELISA Peanut kit.

With the addition of peanut, Hygiena now offers a total of 12 allergen tests in our AlerTox Sticks portfolio, each validated for product, surface, and liquid samples. Tests include includes milk (casein and beta-lactoglobulin separately or combined), egg, fish, crustacean, soy, mustard seed and almond, walnut, and hazelnut and now peanut.

ABOUT HYGIENA

Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, healthcare, hospitality, pharmaceuticals, and personal care. Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based pathogen detection and characterization systems, allergen tests, mycotoxin tests, environmental collection devices, and more. Hygiena is committed to the mission of providing customers with high-quality innovative technologies that are easy-to-use and reliable, backed by excellent customer service and support. Headquartered in Camarillo, California with offices in Wilmington, Delaware, Mexico, Spain, Canada, the United Kingdom and China, and over 80 distributors in more than 100 countries worldwide, Hygiena products span the globe. www.hygiena.com.

 NEW BAX® SYSTEM REAL-TIME PCR ASSAY FOR E. COLI O157:H7 EXACT MORE PRECISELY DETECTS DEADLY BACTERIA IN FOOD 

Improved assay reduces time to product release by detecting bacteria faster

 

CAMARILLO, Calif. (23 October 2020)— Hygiena, a leader in food safety testing, announced the NEW BAX® System Real-Time PCR Assay for E. coli O157:H7 Exact, a test that can specifically identify Escherichia coli O157:H7 bacteria (and not similar serotypes) in less time than other tests.

The BAX® technology is based on the polymerase chain reaction (PCR) method of amplifying minute amounts of genetic material in a sample for more accurate measurement. The new BAX® System Real-Time Assay for E. coli O157:H7 Exact is based on a single genetic target in E. coli O157:H7, providing a definitive result for immediate action and minimizes the need for additional confirmatory testing.

Improved chemistry in the new assay allows detection as low as 104 colony forming units (CFU/mL) in an enriched sample, opening the door to reduced enrichment times and faster time to results for quicker product release.

The assay can be run simultaneously with the BAX® System Real-Time PCR assay suite for STEC, including the BAX® System Real-Time STEC screening assay, and BAX® System Real-Time PCR assays for STEC Panel 1 and STEC Panel 2.

Hygiena’s validation testing of the BAX® System Real-Time PCR Assay for E. coli O157:H7 Exact in raw ground beef, beef trim, leafy greens and raw milk showed no significant differences in results compared to the reference conventional culture confirmation method. In addition, the test successfully identified 239 strains of E. coli O157:H7 and did not identify 300 non-O157:H7 strains or 175 non-E. coli bacteria.

“We are so excited to introduce this new assay to the BAX® System! This assay will dramatically improve the accuracy and speed of testing for E. coli O157:H7, providing the industry a needed tool for product release,” said April Englishbey, PhD., product manager at Hygiena. “We are confident that this assay’s ability for improved results in a variety of tough matrices will help improve the safety of food supply chains.”

ABOUT HYGIENA

Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, healthcare, hospitality, pharmaceuticals, and personal care. Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based pathogen detection and characterization systems, allergen tests, mycotoxin tests, environmental collection devices, and more. Hygiena is committed to the mission of providing customers with high-quality innovative technologies that are easy-to-use and reliable, backed by excellent customer service and support. Headquartered in Camarillo, California with offices in Wilmington, Delaware, Mexico, Spain, Canada, the United Kingdom and China, and over 80 distributors in more than 100 countries worldwide, Hygiena products span the globe. www.hygiena.com.

HYGIENA ADDS SPECIFIC WALNUT TEST TO THE ALERTOX RANGE 

 

CAMARILLO, Calif. (13 October 2020) - Hygiena, a leader in food safety testing, is excited to launch a new test to increase its rapid test line of allergens, Alertox® Sticks Walnut. This line of rapid test for allergen detection is designed for the food processing industry to support allergen control programs and labelling requirements.

This lateral flow strip has a limit of detection of 2ppm of walnut protein in food samples. It is also validated of surfaces for cleaning verification. Using monoclonal antibodies to detect allergenic protein in walnut (Juglans regia), the test does not cross-react with the closely related tree nut pecan (Carya illinoinensis), or other allergens.

This product represents a cost effective and rapid solution as the procedure only takes a few minutes and there is no equipment required as all additional elements are included in the 10 test pack. The test can be used for incoming ingredients, finished products or surfaces. It is validated in a wide range of products such as protein bars, bread, dairy products, bakery products, cheese and stainless steel.

Hygiena’s Alertox line of rapid allergen tests includes milk (casein and beta-lactoglobulin separately or combined), egg, fish, crustacean, soy, mustard seed, almond and hazelnut (both for food analysis and surface testing). – Contact Hygiena for further information and learn more about the range of allergen tests.

ABOUT HYGIENA

Hygiena delivers rapid microbial detection, monitoring, and identification solutions to a wide range of industries, including food and beverage, healthcare, hospitality, pharmaceuticals, and personal care. Utilizing advanced technologies and patented designs, Hygiena provides industry-leading ATP monitoring systems, PCR-based pathogen detection and characterization systems, allergen tests, mycotoxin tests, environmental collection devices, and more. Hygiena is committed to the mission of providing customers with high-quality innovative technologies that are easy-to-use and reliable, backed by excellent customer service and support. Headquartered in Camarillo, California with offices in Wilmington, Delaware, Mexico, Spain, Canada, the United Kingdom and China, and over 80 distributors in more than 100 countries worldwide, Hygiena products span the globe. www.hygiena.com.

 

Hygiena Releases GlutenTox ELISA Rapid G12, A More Sensitive, Faster Gluten Test

Improved test provides significant advance in determining gluten in food

Hygiena, a leader in food safety testing, announced the release of GlutenTox ELISA Rapid G12, an improved test for the most immunotoxic peptide in gluten. The test provides more accurate results in less time than either previous versions or competitors’ ELISA tests for gluten.

GlutenTox ELISA Rapid G12 uses the G12 antibody to identify in food samples the 33-mer (part) peptide segment of the gliadin protein, which is part of the gluten protein complex. This “33-mer” peptide is the most immunotoxic part of the gluten protein and induces celiac disease in susceptible people. The 33-mer peptide also shows high resistance to complete digestion by human digestive enzymes.  Focusing on this peptide fragment provides more objective information to help people with celiac disease and gluten intolerance to avoid foods that contain gluten.

GlutenTox ELISA Rapid G12 provides fast, convenient and accurate measurement of gluten down to 0.6 ppm (0.3 ppm of gliadin).

GlutenTox ELISA Rapid G12 is based on the enzyme-linked immunoassay (ELISA) test, a proven laboratory workhorse for more than 40 years. This test first uses the G12 antibody that is fixed to a testing surface (the “capture” antibody). This antibody binds specifically to certain peptides (in this case, the 33-mer). A second antibody, the “detection antibody,” is then introduced, labeled with an enzyme so it and its accompanying target protein can be measured. The “capture” antibody determines what proteins the “detection” antibody can pinpoint. 

In addition, standards provided with the kit will be ready-to-use for the first time. This innovation will reduce operator errors, as well as the time needed to prepare assays. The new kit is also more stable during temperature changes, and delivers positive results even in highly contaminated samples (a limitation of other gluten tests). Finally, GlutenTox ELISA Rapid G12 tests have shorter incubation times, allowing for an accurate-analytic measurement of gluten in 90 minutes.  

“With additional benefits like faster time to results, less susceptibility to temperature and nontoxic reagents, we are confident this new test will mark a significant advance in the ability to detect gluten proteins that are so harmful to those sensitive to even low levels of gluten.,” said Charles McGuill, Product Manager at Hygiena.

Hygiena launches improved, rapid Listeria species detection method

InSite Listeria--certified by AOAC RI--reduces time, cost and labor over traditional screening

Hygiena, a global leader in food safety, introduced InSite Listeria, a new easy-to-use all-in-one environmental test for Listeria species, which has been certified by AOAC RI.

The new InSite Listeria test was certified as an AOAC RI Performance Tested MethodSM (certification number 121902). The certification verifies that the test detects low levels of Listeria species on stainless steel, ceramic and plastic surfaces.

Additional testing by Hygiena scientists showed that the new InSite Listeria could more specifically detect presumed positive Listeria, excluding more non-Listeria species than previous tests. This specificity reduces the need for follow-up testing, further reducing the risks of extended product hold times.

Each new InSite Listeria device contains liquid media pre-measured with antibiotics, growth enhancers, and color-changing compounds specific to Listeria species. Within 48 hours, the test changes color in the presence of Listeria species. The test is used for environmental monitoring in food processing facilities, food preparation environments and food retailers after cleaning. Screening out negative samples quickly and easily provides a cost-effective way to increase surveillance, monitor hazards and control risks.

“Food safety professionals have been looking for more convenient, cost-effective ways to detect Listeria, and we are excited about being able to fill that gap with InSite Listeria,” said Brandon Katz, research and development manager at Hygiena. “The improved specificity of this new test will also make detecting the possible presence of Listeria a much simpler process.”

The new InSite Listeria testing method is self-enclosed and does not require complex laboratory equipment, or additional reagents, reducing sample cross-contamination risks. The new InSite Listeria arrives as government regulators worldwide make monitoring and controlling Listeria a priority.

New Aflatoxin M1 Ultra ELISA Quantitative Test Introduced

Test in milk products has broadest, most sensitive detection in industry

Hygiena’s Helica Biosystems has introduced a new test for aflatoxin M1, a carcinogenic chemical found in milk products. Studies found the enzyme-linked immunoassay (ELISA), Aflatoxin M1 Ultra ELISA Quantitative, is more sensitive than competitors’ tests for detecting the toxin.

Aflatoxin M1 is found in the milk of cows that eat Aflatoxin B1-contaminated feed. Aflatoxin B1 is one of the world’s most carcinogenic compounds. It is produced by molds including Aspergillis flavus and A. parasiticus, commonly found in feeds. While not as toxic as its parent compound Aflatoxin B1, Aflatoxin M1 can still cause cancers, immune system disorders and severe toxic reactions. Dairy processors need fast, accurate tests that detect low levels of Aflatoxin M1 in their milk, milk powder and yogurt products.

In the United States, the highest concentration of Aflatoxin M1 allowed in products is 500 parts per trillion (ppt). In the European Union, that limit is 50 ppt. In addition, ISO 14675 guidelines require a minimum quantification of 10 ppt, less than 20 percent cross-reactivity to the related Aflatoxin M2, and a standard range of 5-50 ppt.

The new Aflatoxin M1 Ultra ELISA Quantitative has a broad detection range of 5 ppt to 500 ppt. The ELISA assay takes only 1 hour, 10 minutes to generate results. This year, an independent laboratory verified the performance of Aflatoxin M1 Ultra ELISA Quantitative with a competing kit, validating its 5-500 ppt detection in milk samples, with high sample recovery, and high testing precision and accuracy. All Hygiena assay outperformed competing kit.

Aflatoxin M1 Ultra ELISA also shows less than 0.1% cross-reactivity to other aflatoxin types (M2, B1, B2, G1 and G2) that could cause false-positive results in the presence of these other aflatoxin types. These types can exist in barley, walnut, oats and other grains and nuts often added to dairy products.

“Hygiena’s Helica brand of mycotoxin tests has been supplying dairy markets worldwide for 15 years with effective assays,” said Charles McGuill, product manager at Hygiena. “The new high sensitivity aflatoxin M1 assay ELISA kit meets all regulatory requirements and effectively determines the presence of aflatoxin M1.”