Evaluation of a Revised U.S. Food and Drug Administration Method for the Detection of Cronobacter in Powdered Infant Formula: A Collaborative Study
Abstract:A revised U.S. Food and Drug Administration (FDA) method for the isolation and detection of Cronobacter from powdered infant formula was recently developed, which combines real-time PCR, chromogenic agars, and RAPID ID 32E biochemical tests. This method provides an expedient analysis within 24 to 48 h. A collaborative validation study involving four different laboratories was conducted to compare the revised FDA method with the reference FDA method using casein- and soy-based powdered infant formula inoculated with different Cronobacter strains. Valid results from 216 test portions and controls from collaborating laboratories were obtained and showed that the revised FDA method performed significantly better than the reference FDA method. Newly revised PCR protocols and VITEK 2 were also evaluated to be integrated into the complete detection procedure.
Document Type: Research Article
Affiliations: 1: Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740, USA. firstname.lastname@example.org 2: Southeast Regional Laboratory, U.S. Food and Drug Administration, 60 8th Street N.E., Atlanta, Georgia 30309, USA 3: Northeast Regional Laboratory, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433, USA 4: San Francisco District Laboratory, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, California 94802, USA 5: Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740, USA
Publication date: June 1, 2012
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