Durham, N.C. - May 26, 2011.
U.S. FDA Recommends bioMérieux’s VIDAS® Staphylococcal Enterotoxin Assay (SET2) as Primary Screening Method for Food Safety Testing
bioMérieux, a world leader in the field of in vitro diagnostics, announced today that the VIDAS® Staphylococcal enterotoxins assay (SET2) has been included in the United States Food and Drug Administration’s (FDA) Bacteriological Analytical Manual (BAM) for food safety testing. The FDA’s BAM is recommending that the VIDAS SET2 protocol be used as the primary screening method for the presence of Staphylococcal enterotoxins in suspect food samples and culture isolates.
Among the metabolites produced by Staphylococcus aureus and other staphylococcal spp., enterotoxins present the greatest foodborne risk to the health of consumers. When these staph organisms proliferate in foods, they may produce enough toxins to cause food poisoning once the food is ingested. Most systems used to test for these toxins utilize a complete antibody that has not been specifically modified for detection of staphylococcal enterotoxins and can therefore lead to false positive results. Research has demonstrated that using modified antibodies in the detection of staphylococcal enterotoxins enhances antibody quality and ensures a greater degree of specificity.
“bioMérieux is committed to helping food producers and processors ensure the safety and quality of their products,” said Stan Bailey, Ph.D., director of scientific affairs for bioMérieux Industry. “We developed the innovative VIDAS SET2, using our proprietary approach to antibody modification for greater sensitivity and specificity, in response to the need for a faster method of Staphylococcal testing with more reliable results. The FDA’s decision to include the VIDAS SET2 as part of the BAM to ensure high quality testing for serious foodborne pathogens further validates this assay as an important, scientific pathogen detection technique.”
Staphylococcus aureus is among the most prevalent causes of clinical infections globally and has garnered substantial public attention due to increasing mortality associated with multidrug resistance. The recent findings from A. Waters et al published in Clinical Infectious Diseases, reports on the prevalence and antibiotic susceptibility profiles of S. aureus in retail meat and poultry samples from five U.S. cities. S. aureus was found in 47 percent of the samples tested, and multidrug resistance was present among 52 percent of isolates, including resistance to clinically important antibiotics.1
The most common symptoms of staphylococcal food poisoning usually begin two to six hours after contaminated food is consumed and may cause nausea, vomiting, acute prostration and abdominal cramps. Foods incriminated have included meat, poultry, canned mushrooms, dairy products, eggs and mayonnaise.2
1- Waters, A.E., Contente-Cuomo,T., Buchhagen, J., Liu, C.M., Watson, L., Pearce, K., Foster, J.T., Bowers, J., Driebe, E.M., Engelthaler, D.M., Keim, P.S., Price, L.B., Clinical Infectious Diseases Brief Report, 2011:52, April 15, 2011.
2- Wieneke, A.A., Gilbert, R.J., int. J. Food Microbiol.4, 1987, 135-143.
About bioMérieux Food Safety
bioMérieux has been a global leader in providing innovative solutions to address food safety testing issues for more than 20 years. bioMérieux's food safety focus encompasses prevention, detection and quality assurance. The company offers extensive global resources and local expertise in microbiology and food safety, driven by cutting-edge research and science to bring powerful new tools to the food industry. bioMérieux's food testing solutions, including prepared culture media, VIDAS®, TEMPO®, BacT/ALERT®, VITEK® 2 and DiversiLab®, reflect its commitment to improving public health through a safe and nutritious food supply accessible globally. To learn more about food safety and quality solutions from bioMérieux, visit www.biomerieux-usa.com or call 1-800-634-7656.
Advancing Diagnostics to Improve Public Health
A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than150 countries through 39 subsidiaries and a large network of distributors. In 2010, revenues reached €1.357 billion with 87% of sales outside of France.
bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479).
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