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FDA Method Equivalency for Salmonella Enteritidis PCR Assay

Life Technologies Corporation have announced that the U.S. Food and Drug Administration has extended its recent method equivalency finding of the Applied Biosystems TaqMan® Salmonella Enteritidis Detection Kit to test poultry eggs for additional use on environmental samples at production houses where the breakfast staple is handled and packaged.

The kit had previously received interim approval for environmental sample testing by the National Poultry Improvement Plan (NPIP), a division of the United States Department of Agriculture (USDA), which governs safety standards at poultry houses that produce animals destined for dinner tables around the world. This equivalency finding gives Life Technologies regulatory approvals for testing SE in egg and poultry houses.

The latest government findings now provide egg producers and the poultry industry the market's only PCR-based tool, to quickly and accurately determine the presence or absence of Salmonella Enteritidis (SE) in drag swab samples taken from production lines by directly zeroing in on the pathogen's DNA. Compared to conventional, culture-based methods of detection, the kit reduces the time to results to 27 hours versus 72 hours — roughly 10 times faster for egg samples, and three times faster for environmental drag swab samples.

This kit accurately differentiates SE from other serogroup D1 Salmonella to which SE belongs. 'We appreciate the work of Life Technologies to develop testing methods and tools that will provide egg farmers with rapid, reliable test results so that eggs are not withheld from the market even one day longer than necessary,' said Gene Gregory, President and CEO of United Egg Producers.

Life Technologies developed the Applied Biosystems TaqMan® Salmonella Enteritidis Detection Kit in response the Federal Egg Safety Program and launched it in January 2011 when the FDA determined that the test was equivalent in accuracy, precision and sensitivity to its current standard methods described in the federal agency's Bacteriological Analytical Manual (BAM, December 2007 Edition). Passed in July 2010, the Egg Safety Program requires all large-scale egg producers in the U.S. -- roughly 80 percent of the egg production industry -- to test for SE, and is estimated to reduce annual Salmonella-related illnesses and deaths by 60 percent , according to the FDA.

'Acceptance of our detection kit for Salmonella Enteritidis by the FDA and the NPIP is in line with our strategic goal to provide the most accurate of reliable molecular tools, and to continue growing our business in this sector,' said Nir Nimrodi, Vice President and General Manager of Animal Health and Food Safety. 'In addition to providing a valuable testing method with dual uses, the kit can help producers easily conform to federal regulations.'

 


     
Tags: Poultry, Salmonella, Swabs, PCR, Pathogen, FDA

Date Published: April 24, 2012 » company contact details
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