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- Title
Validation of the Listeria Right Now<sup>TM</sup>Test for Detection of Listeria spp. from Selected Environmental Surfaces Without Enrichment.
- Authors
Quynh-Nhi Le; Alles, Susan; Roman, Brooke; Tovar, Eric; Hosking, Edan; Lei Zhang; Biswas, Preetha; Bastin, Benjamin; Bird, Patrick M.; Mozola, Mark; Donofrio, Robert
- Abstract
Background: Listeria Right NowTMis a novel, enrichment-free molecular method for detection of Listeria spp. in swab samples from environmental surfaces. The test provides results in real time, indicating the current or recent presence of Listeria spp. in the environment. After sampling, the entire contents of the swab are subject to sample processing, releasing large quantities of target ribosomal RNA molecules into the lysate. A portion of the lysate is then tested using the ANSR® for Listeria isothermal nucleic acid amplification assay. Objective: A Performance Tested MethodSM study was conducted to validate the method for detection of Listeria spp. in swab samples from stainless steel and sealed concrete surfaces. Methods and Results: In inclusivity testing, 60 of 60 Listeria spp. strains tested positive. In exclusivity testing, 31 of 31 nontarget bacterial strains tested negative. In LOD testing, the test was able to detect as few as 2 CFU of L. monocytogenes applied to a stainless steel surface. In matrix testing of inoculated stainless steel and sealed concrete surfaces, there were no statistically significant differences in method performance comparing the Listeria Right Now and U.S. Food and Drug Administration Bacteriological Analytical Manual reference culture procedures as determined by probability of detection analysis. In robustness testing, modest changes to three assay operating parameters simultaneously did not significantly affect performance of the test. Conclusions and Highlights: Results can be obtained in less than 1 h using the Listeria Right Now test, allowing food industry personnel to take immediate corrective action in the case of Listeria contamination incidents.
- Subjects
LISTERIA; STAINLESS steel; RIBOSOMAL RNA; NUCLEIC acid amplification techniques; REVERSE transcriptase
- Publication
Journal of AOAC International, 2019, Vol 102, Issue 3, p926
- ISSN
1060-3271
- Publication type
Article
- DOI
10.5740/jaoacint.18-0277