Banerjee K , Peirson B , Hu C , Carrier E , Malsick L , Tarasova Y , Daudenarde S , Brownell D , Koeris M , Klass N , Bird P , Benzinger MJ , Agin J , Goins D
J AOAC Int.2018 Apr 04 ; ():.
PMID: 29618405[PubMed - as supplied by publisher]
:spp. are an important foodborne human pathogenbecause of their ability to cause disease and high mortality in individuals, particularly pregnant women, neonates, the elderly, immunocompromised individuals, and children. The Sample6 DETECTHT/L Kit is a semi-automated qualitative pathogen detection system designed to detectspp. () in environmental samples using the Sample6 BioIlluminationtechnology.: The study was done to evaluate the Sample6 DETECT HT/L Kit. The assay was evaluated for inclusivity, exclusivity, robustness, product consistency, and stability, and a matrix study of one environmental surface.: The performance of the Sample6 DETECT HT/L was compared with U.S. Food and Drug Administration reference culture method forusing an unpaired study design.: The Sample6 DETECT HT/L assay correctly identified all 50 inclusivity isolates and correctly excluded all 30 nontarget strains evaluated. The assay was not affected by minor variations in incubation temperature and time, or sample volume. Results across three production lots spanning the shelf life of the assay were consistent. In the matrix study, the Sample6 DETECT HT/L forcorrectly identified each test portion for the presence or absence of, and there were no statistically significant differences between candidate and reference method results.: The data collected in this study demonstrate that the Sample6 DETECT HT/L assay is a reliable method for the detection ofspp. on stainless-steel environmental surfaces after 22 h of enrichment.