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FDA Equivalency for PCR Detection Kit for Salmonella Enteridits in Eggs

A collaboration between Life Technologies Corporation and the University of Pennsylvania School of Veterinary Medicine has led to the launch of the first real-time PCR-based detection kit to test for Salmonella Enteritidis (SE) in poultry eggs, providing an approximate 10-fold reduction in waiting time for accurate results.

The FDA has determined that the Applied Biosystems TaqMan® Salmonella Enteritidis Detection Kit by Life Technologies is equivalent in accuracy, precision and sensitivity to its current standard methods described in the FDA's Bacteriological Analytical Manual (BAM, December 2007 Edition). The company's solution is a comprehensive protocol that uses real-time PCR to quickly determine the presence or absence of SE in egg samples.

Unlike the current traditional testing method, which can take up to 10 days to complete, Life Technologies' solution reaches accurate results in about 27 hours, making it the only tool of its kind on the market.

'The faster turnaround time to reach accurate results with this new molecular test not only enables egg producers to easily conform to the FDA's new stringent testing standards, but also helps limit the negative economic impact associated with SE outbreaks,' said Gene Gregory, President and CEO of the United Egg Producers.

The Federal Egg Safety Program, which went into effect July 2010, requires all large-scale egg producers in the U.S. -- roughly 80 percent of the egg production industry -- to test for SE to ensure the safety of products before they reach supermarket shelves. The new regulations created the need for a quicker, yet highly accurate, testing method.

NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source: Applied Biosystems View latest company information

Posted: February 1, 2011
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