title: DuPont qualicon BAX system real-time PCR assay for Escherichia coli O157:H7.
abstract: Evaluations were conducted to test the performance of the BAX System Real-Time PCR assay, which was certified as Performance Tested Method 031002 for screening E. coli O157:H7 in ground beef, beef trim, spinach, and lettuce. Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent or superior to the FDA-BAM and the USDA-FSIS culture methods, but with a significantly shorter time to result. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined affect the performance of the assay. An accelerated shelf life study determined an initial 36 month shelf life for the test kit.
authors.affiliation: DuPont Qualicon, ESL Bldg 400, PO 80400, Rt. 141 and Henry Clay Rd, Wilmington, DE 19880-0400, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Burns
authors.forename: Lois
authors.initials: L
authors.lastname: Fleck
authors.forename: Bridget
authors.initials: B
authors.lastname: Andaloro
authors.forename: Eugene
authors.initials: E
authors.lastname: Davis
authors.forename: Jeff
authors.initials: J
authors.lastname: Rohrbeck
authors.forename: George
authors.initials: G
authors.lastname: Tice
authors.forename: Morgan
authors.initials: M
authors.lastname: Wallace
mesh_terms: D000818:Animals; D004783:Environmental Microbiology; D019453:Escherichia coli O157 / Q000302:isolation & purification*; D005516:Food Microbiology / Q000379:methods*; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods*