title: Comparison of FoodChek E. coli test and AOAC Research Institute Performance Tested Method 010603 for detection of E. coli O157 in raw ground beef.
abstract: The FoodChek E. coli P157 assay [AOAC Research Institute (RI) Performance Tested Method (PTM) 060902] is a rapid detection system that incorporates the use of antibody-coated superparamagnetic nanoparticles in a lateral flow immunoassay format. The system comprises a commercially available enrichment medium, a magnetic nanoparticle immunoassay, and an automated reader for detection. Assay detection threshold is improved relative to traditional immunoassays through use of a magnetic nanoparticle label and a highly sensitive magnetic particle detector. FoodChek E. coli O157 is a reintroduction of the previously certified AOAC PTM 010603. The original assay was evaluated and approved in internal and independent laboratory studies. Vacci-Test Corp. has contracted with the original supplier of the PTM to remanufacture the test under identical conditions and with identical raw materials. This report is intended to show that FoodChek E. coli is identical in performance to the previously approved PTM. The results showed no difference for the parameters evaluated. Three kit lots along with three lots of media and media supplement were compared in lot-to-lot and stability testing. The results indicated no difference in performance across the three lots. The results showed sensitivity of > 99% and a specificity rate of > 98% for the FoodChek method and a significantly higher sensitivity than the reference method.
authors.affiliation: Vacci-Test Corp., Suite 1005, 550 11th Ave SW, Calgary, Alberta, Canada T2R 1M7.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Flanagan
authors.forename: Gabriela
authors.initials: G
authors.lastname: Martinez
mesh_terms: D000818:Animals; D001431:Bacteriological Techniques / Q000379:methods*; D002417:Cattle; D019453:Escherichia coli O157 / Q000302:isolation & purification*; D008460:Meat / Q000382:microbiology*