title: Validation of the Reveal(®) 2.0 Group D1 Salmonella Test for Detection of Salmonella Enteritidis in Raw Shell Eggs and Poultry-Associated Matrixes.
abstract: A study was conducted to assess the performance of the Reveal(®) 2.0 Group D1 Salmonella lateral flow immunoassay for use in detection of Salmonella Enteritidis (SE) in raw shell eggs and poultry-associated matrixes, including chicken carcass rinse and poultry feed. In inclusivity testing, the Reveal 2.0 test detected all 37 strains of SE tested. The test also detected all but one of 18 non-Enteritidis somatic group D1 Salmonella serovars examined. In exclusivity testing, none of 42 strains tested was detected. The exclusivity panel included Salmonella strains of somatic groups other than D1, as well as strains of other genera of Gram-negative bacteria. In matrix testing, performance of the Reveal 2.0 test was compared to that of the U.S. Department of Agriculture, Food Safety and Inspection Service Microbiology Laboratory Guidebook reference culture procedure for chicken carcass rinse and to that of the U.S. Food and Drug Administration Bacteriological Analytical Manual for raw shell eggs and poultry feed. For all matrixes evaluated, there were no significant differences in the ability to detect SE when comparing the Reveal 2.0 method and the appropriate reference culture procedure as determined by probability of detection statistical analysis. The ability of the Reveal 2.0 test to withstand modest perturbations to normal operating parameters was examined in robustness experiments. Results showed that the test can withstand deviations in up to three operating parameters simultaneously without significantly affecting performance. Real-time stability testing of multiple lots of Reveal 2.0 devices established the shelf life of the test device at 16 months postmanufacture.
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: Preetha
authors.initials: P
authors.lastname: Biswas
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: Emily
authors.initials: E
authors.lastname: Feldpausch
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Debra
authors.initials: D
authors.lastname: Foti
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Lin
authors.initials: L
authors.lastname: Li
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: Susan
authors.initials: S
authors.lastname: Alles
authors.affiliation: Neogen Corp., 620 Lesher Pl, Lansing, MI 48912.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rice
mesh_terms: D000818:Animals; D004531:Eggs / Q000382:microbiology*; D005516:Food Microbiology; D007118:Immunoassay; D011200:Poultry; D012477:Salmonella enteritidis / Q000302:isolation & purification*