title: Validation of the ANSR® forCampylobacterMethod for Detection of ThermophilicCampylobacterspp. in Chicken Carcass Rinse and Turkey Sponge Samples.
abstract: A performance validation of the ANSR® for Campylobacter method was conducted in selected matrixes. This assay used selective nicking enzyme amplification technology to amplify target genes. Samples were enriched for 20 to 24 h and then lysed. The assay was completed within 50 min using real-time detection in a combination incubator/fluorescence detector and software. When 50 distinct strains of Campylobacter jejuni, C. lari, or C. coli were tested for inclusivity, all 50 strains produced positive results. In exclusivity testing, 31 strains of related organisms, including seven nontarget Campylobacter strains and other common species, were evaluated. All 31 species generated negative ANSR assay results, including the nontarget Campylobacter strains. The ANSR for Campylobacter method was compared to the U.S. Department of Agriculture, Food Safety and Inspection Service Microbiology Laboratory Guidebook reference method using naturally contaminated chicken carcass rinse or turkey carcass sponge samples. ANSR method performance was not statistically different from the reference method using two different enrichment options. Equivalent results were observed at both time points (20 and 24 h) and in both atmospheres (microaerobic and aerobic) to reference methods. Method performance with chicken carcass rinse was confirmed in an independent laboratory study. Additionally, in robustness testing, small, deliberate changes to the assay parameters minimally affected ANSR method performance. Finally, accelerated stability results from three independently manufactured lots supported a shelf life of 6 months when stored at 4°C. The ANSR assay offered greater efficiency and flexibility when compared to the reference method with a 20-24 h single-step enrichment in a microaerobic or an aerobic atmosphere.
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Ryan
authors.initials: R
authors.lastname: Viator
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Susan
authors.initials: S
authors.lastname: Alles
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Quynh-Nhi
authors.initials: QN
authors.lastname: Le
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Edan
authors.initials: E
authors.lastname: Hosking
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Preetha
authors.initials: P
authors.lastname: Biswas
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Jerry
authors.initials: J
authors.lastname: Tolan
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Evan
authors.initials: E
authors.lastname: Meister
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Eric
authors.initials: E
authors.lastname: Tovar
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Lisa
authors.initials: L
authors.lastname: Pinkava
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Mark
authors.initials: M
authors.lastname: Mozola
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rice
authors.affiliation: U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, College Park, MD 20740.
authors.forename: Yi
authors.initials: Y
authors.lastname: Chen
authors.affiliation: University of Guelph, Laboratory Services Division, 95 Stone Rd West, Guelph, Ontario H1H 8J7 Canada.
authors.forename: Joseph
authors.initials: J
authors.lastname: Odumeru
authors.affiliation: 1301 Kristen Ln, Loganville, GA 30052.
authors.forename: Wayne
authors.initials: W
authors.lastname: Ziemer
mesh_terms: D000818:Animals; D002167:Campylobacter / Q000302:isolation & purification*; D002645:Chickens / Q000382:microbiology; D008460:Meat / Q000382:microbiology*; D012984:Software; D013050:Spectrometry, Fluorescence; D013696:Temperature; D014422:Turkeys / Q000382:microbiology