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Comparative validation study to demonstrate the equivalence of a minor modification to AOAC official method 2005.04 assurance GdS E. coli 0157:H7 method to the reference culture method: 375 gram sample size. 2013

Philip T Feldsine, and Megan Montgomery-Fullerton, and Nerie Roa, and Mandeep Kaur, and Andrew H Lienau, and Markus Jucker, and David E Kerr
BioControl Systems, Inc., 12822 SE 32nd St, Bellevue, WA 98005, USA. ptf@biocontrolsys.com

The Assurance GDS Escherichia coli (E. col) O157:H7, AOAC Official Method 2005.04, has been modified to include a larger sample size of 375 g. A methods comparison study was conducted to demonstrate the equivalence of this modification to the reference culture method. Ninety samples and controls, representing three foods, were analyzed. Results show no statistically detectable difference between the Assurance GDS E. coli O157:H7 assay and the reference culture methods for the detection of E. coli O157:H7, other than the low level of inoculation for leaf lettuce, for which the GDS gave noticeably higher recovery [difference in probability of detection between candidate methods (dPODc = +0.45)]. There were also suggestions of moderate differences (dPODc = +0.15 to +0.20) for ground beef and the high level of leaf lettuce, but the study size was too small to detect differences of this size. Results showed that the Assurance GDS E. coli O157:H7 method is equivalent to reference culture methods for the detection of E. coli O157:H7.

UI MeSH Term Description Entries
D003470 Culture Media Any liquid or solid preparation made specifically for the growth, storage, or transport of microorganisms or other types of cells. The variety of media that exist allow for the culturing of specific microorganisms and cell types, such as differential media, selective media, test media, and defined media. Solid media consist of liquid media that have been solidified with an agent such as AGAR or GELATIN. Media, Culture
D005516 Food Microbiology The presence of bacteria, viruses, and fungi in food and food products. This term is not restricted to pathogenic organisms: the presence of various non-pathogenic bacteria and fungi in cheeses and wines, for example, is included in this concept. Microbiology, Food
D018401 Sample Size The number of units (persons, animals, patients, specified circumstances, etc.) in a population to be studied. The sample size should be big enough to have a high likelihood of detecting a true difference between two groups. (From Wassertheil-Smoller, Biostatistics and Epidemiology, 1990, p95) Sample Sizes,Size, Sample,Sizes, Sample
D019453 Escherichia coli O157 A verocytotoxin-producing serogroup belonging to the O subfamily of Escherichia coli which has been shown to cause severe food-borne disease. A strain from this serogroup, serotype H7, which produces SHIGA TOXINS, has been linked to human disease outbreaks resulting from contamination of foods by E. coli O157 from bovine origin. E coli O157,E coli O157-H7,Escherichia coli O157-H7

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