SDIX Salmonella Test Receives FDA Equivalency Determination

The RapidChek SELECT Salmonella Enteritidis (SE) test system from SDIX has been reviewed by the Food and Drug Administration (FDA) and determined to be equivalent in accuracy, precision and sensitivity to its current standard methods for poultry house environmental drag swabs and pooled egg testing. For pooled egg testing, SDIX’s method is considered by FDA as equivalent to its standard test without a 96-hour hold period, thus delivering results with a substantial time and cost advantage.

Recently, SDIX’s test also earned Performance-Tested Methods (PTM) certification from the AOAC Research Institute, validating the method as equivalent to the FDA methodology for detecting SE in poultry house environments and pooled eggs. With the added FDA equivalency determination, SDIX’s test can help the approximately 3,300 egg producers comply with the new FDA regulations and significantly reduce contamination levels. The FDA Final Rule dictates that if SE is found in the layer environment, eggs must then be screened for the presence of SE in order to keep any contaminated eggs from reaching the consumer market. 

The new testing system is comprised of the RapidChek SELECT Salmonella Enteritidis detection system for screening environmental drag swabs or pooled eggs and the RapidChek CONFIRM Salmonella Enteritidis immunomagnetic separation system for confirmation of environmental presumptive positive samples.