title: Modification of the BAX Salmonella test kit to include a hot start functionality (modification of AOAC Official Method 2003.09).
abstract: In 2010, the BAX System PCR assay for Salmonella was modified to include a hot start functionality designed to keep the reaction enzyme inactive until PCR begins. To validate the assay's Official Methods of Analysis status to include this procedure modification, an evaluation was conducted on four food types that were simultaneously analyzed with the BAX System and either the U.S. Food and Drug Administration's Bacteriological Analytical Manual or the U.S. Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook reference method for detecting Salmonella. Identical performance between the BAX System method and the reference methods was observed. Additionally, lysates were analyzed using both the BAX System Classic and BAX System Q7 instruments with identical results using both platforms for all samples tested. Of the 100 samples analyzed, 34 samples were positive for both the BAX System and reference methods, and 66 samples were negative by both the BAX System and reference methods, demonstrating 100% correlation. No instrument platform variation was observed. Additional inclusivity and exclusivity testing using the modified test kit demonstrated the test kit to be 100% accurate in evaluation of test panels of 352 Salmonella strains and 46 non-Salmonella strains.
authors.affiliation: DuPont Qualicon, ESL Bldg 400, Rt 141 and Henry Clay Rd, Wilmington, DE 19880, USA. morgan.wallace@usa.dupont.com
authors.forename: F Morgan
authors.initials: FM
authors.lastname: Wallace
authors.forename: Deana
authors.initials: D
authors.lastname: DiCosimo
authors.forename: Andrew
authors.initials: A
authors.lastname: Farnum
authors.forename: George
authors.initials: G
authors.lastname: Tice
authors.forename: Bridget
authors.initials: B
authors.lastname: Andaloro
authors.forename: Eugene
authors.initials: E
authors.lastname: Davis
authors.forename: Frank R
authors.initials: FR
authors.lastname: Burns
mesh_terms: D003470:Culture Media; D003611:Dairy Products / Q000382:microbiology; D005506:Food Contamination; D005516:Food Microbiology / Q000379:methods*; D007202:Indicators and Reagents; D008460:Meat / Q000382:microbiology; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D012475:Salmonella / Q000737:chemistry* / Q000235:genetics*; D019779:Salmonella enterica / Q000737:chemistry / Q000235:genetics
chemical_list: D003470:Culture Media; D007202:Indicators and Reagents; D011933:Reagent Kits, Diagnostic