1. Validation of Workflow Changes, Phage Concentration and Reformatted Detection Threshold for the Sample6 DETECT/L™ Test: Level 3 Modification
- Author
-
Daniel Robert Brownell, Chuxuan Hu, Kakolie Banerjee, Yvonne Salfinger, Patrick Bird, David Goins, Michael Sandor Koeris, Sophie Daudenarde, Brittney Pierson, Jonathan Flannery, James Agin, Elijah Carrier, Wayne Ziemer, Lauren Malsick, Michael H. Brodsky, Allison Mastalerz, M Joseph Benzinger, and Erin Crowley
- Subjects
Pharmacology ,Bacteriological Techniques ,Chromatography ,Listeria ,010405 organic chemistry ,Computer science ,Detection threshold ,010401 analytical chemistry ,Robustness testing ,Stainless Steel ,01 natural sciences ,Workflow ,0104 chemical sciences ,Analytical Chemistry ,Listeria species ,Food Microbiology ,Environmental Chemistry ,Bacteriophages ,Agronomy and Crop Science ,Food Science - Abstract
The AOAC Research Institute Performance Tested MethodsSM Program certified Sample6 DETECT/L™ in April 2014 (Certification No. 041401) for the detection of Listeria species (L. monocytogenes, L. innocua, L. ivanovii, L. seeligeri, L. marthii, L. welshimeri) on stainless steel environmental surfaces. A modification was approved in January 2016, increasing the concentration of sanitizer-neutralizing reagents in detection reagents, increasing the number of phage in the detection solution, and increasing the sample test volume. Moreover, changes to reduce the number of negative controls and add compatibility with polyurethane sponges were also approved. In this modification, to ensure that DETECT/L continues to meet performance expectations, Sample6 evaluated workflow changes to enhance sensitivity and the ease-of-use of the assay. Changes to the phage concentration and detection threshold, plus the inclusion of a confirmation step (DETECT Check), were validated to obtain better accuracy and optimize assay performance. Inclusivity, exclusivity, and robustness testing were conducted by Sample6 to evaluate the changes. A third-party laboratory compared the DETECT/L assay and the U.S. Department of Agriculture reference method in a stainless steel environmental surface matrix study. The data presented in this report demonstrate that the changes proposed to the DETECT/L assay meet or exceed the performance in the current configuration.
- Published
- 2018
- Full Text
- View/download PDF