Evaluation of a Revised U.S. Food and Drug Administration Method for the Detection and Isolation of Enterobacter sakazakii in Powdered Infant Formula: Precollaborative Study

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Abstract:

A revised U.S. Food and Drug Administration (FDA) method for the detection and isolation of Enterobacter sakazakii in powdered infant formula was developed based on real-time PCR technology complemented by culture isolation on chromogenic agars. A validation study was conducted to compare the revised FDAmethod to the reference FDAmethod. Casein and soy powdered infant formula inoculated with morphologically typical and atypical strains of E. sakazakii were analyzed. Valid results were obtained from 360 test portions and controls and showed that the revised FDAmethod is significantly better (P < 0.05) than the reference FDAmethod for the detection of typical E. sakazakii strains and the two methods are equivalent for the detection of atypical E. sakazakii strains.

Document Type: Research Article

Affiliations: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, College Park, MD 20740.

Publication date: May 28, 2009

More about this publication?
  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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