title: Evaluation of DuPont Qualicon Bax System PCR assay for yeast and mold.
abstract: Evaluations were conducted to test the performance of the BAX System PCR assay which was certified as Performance Tested Method 010902 for screening yeast and mold in yogurt, corn starch, and milk-based powdered infant formula. Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent to the U.S. Food and Drug Administration's Bacteriological Analytical Manual culture method, but with a significantly shorter time to obtain results. 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 affected the performance of the assay.
authors.affiliation: DuPont Qualicon, ESL Bldg 400, PO 80400, Rt. 141 Henry Clay Rd, Wilmington, DE 19880-0400, USA. morgan.wallace@usa.dupont.com
authors.forename: F Morgan
authors.initials: FM
authors.lastname: Wallace
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: Andrew
authors.initials: A
authors.lastname: Farnum
authors.forename: George
authors.initials: G
authors.lastname: Tice
authors.forename: Joanne
authors.initials: J
authors.lastname: Ruebl
mesh_terms: D005516:Food Microbiology; D005658:Fungi / Q000302:isolation & purification*; D041943:Infant Formula; D016133:Polymerase Chain Reaction / Q000379:methods*; D015003:Yeasts / Q000302:isolation & purification*; D015014:Yogurt / Q000382:microbiology; D003313:Zea mays / Q000382:microbiology