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Cambridge, MA, United States

Cappillino M.,Sample6 | Shivers R.P.,Sample6 | Brownell D.R.,Sample6 | Jacobson B.,Sample6 | And 10 more authors.
Journal of AOAC International | Year: 2015

The Sample6 DETECT/L™ Kit is a rapid screening assay that utilizes proprietary Sample6 Bioillumination™ technology for the detection of Listeria species on environmental surfaces. The assay was evaluated according to AOAC guidelines for inclusivity, exclusivity, robustness, instrument variation, and product consistency and stability, as well as in a method comparison study using one environmental surface. The validation was conducted using an unpaired study design for the detection of Listeria species on stainless steel surfaces. Statistical analyses were conducted according to the probability of detection statistical model for the robustness, stability, instrument variation and method comparison studies. The Sample6 DETECT/L assay correctly identified all 50 inclusivity isolates and correctly excluded all 30 nontarget strains evaluated in the inclusivity and exclusivity studies. The robustness study demonstrated that the assay was not affected by variations in incubation temperature, incubation time, or the volume of the detection reagent substrate. Regarding instrument variation, no differences were observed between replicates analyzed using three different instruments. In the stability study consistent results were obtained from three different product lots spanning the shelf life of the assay. The results of the statistical analysis of the method comparison indicated there was no significant difference between the Sample6 DETECT/L method and the reference method with the exception of sensitivity where the Sample6 method was superior to the reference. Source

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