Evaluation of a revised U.S. Food and Drug Administration method for the detection of Cronobacter in powdered infant formula: a collaborative study.
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.
Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740, USA. yi.chen@fda.hhs.gov
Yi
Y
Chen
Kathy E
KE
Noe
Sandra
S
Thompson
Carol A
CA
Elems
Eric W
EW
Brown
Keith A
KA
Lampel
Thomas S
TS
Hammack
D000362:Agar; D001431:Bacteriological Techniques / Q000379:methods*; D002863:Chromogenic Compounds; D015169:Colony Count, Microbial / Q000379:methods*; D059126:Cronobacter / Q000302:isolation & purification*; D044083:Cronobacter sakazakii / Q000302:isolation & purification; D003470:Culture Media; D005506:Food Contamination / Q000032:analysis*; D005516:Food Microbiology; D006801:Humans; D007225:Infant Food / Q000382:microbiology*; D041943:Infant Formula / Q000592:standards; D007231:Infant, Newborn; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D013045:Species Specificity; D014481:United States; D014486:United States Food and Drug Administration
D002863:Chromogenic Compounds; D003470:Culture Media; D000362:Agar