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Independent Validation for the Polyskope 1.0 Multiplex Pathogen Detection Assay for the Detection of Shiga Toxin-Producing Escherichia coli Non-O157 STEC, Escherichia coli O157, Listeria monocytogenes, and Salmonella Species
- Source :
- Journal of AOAC International. 102(5)
- Publication Year :
- 2019
-
Abstract
- Background: The Polyskope 1.0 Multiplex Assay is a novel test to simultaneously detect Escherichia coli O157, non-O157 Shiga Toxin-Producing E. coli (STEC), Listeria monocytogenes, and Salmonella species in a single enrichment using real-time PCR. Objective: A Performance Tested MethodSM study was conducted to validate Polyskope 1.0 for inclusivity and exclusivity as well as a matrix comparison study. Method: This assay was evaluated in an unpaired independent validation study compared with reference methods according to AOAC INTERNATIONAL validation guidelines. Polyskope 1.0 evaluated raw ground beef (25 g), deli turkey (25 g), baby spinach (25 g), and stainless-steel environmental surface sponges (4 × 4 in. test area) after inoculation with a suspension of the three target microorganisms. All matrices were compared with appropriate reference methods from the U.S. Food and Drug Administration Bacteriological Analytical Manual, U.S. Department of Agriculture Food Safety and Inspection Service Microbiology Laboratory Guidebook, or International Organization for Standardization standards. Results: Polyskope 1.0 demonstrated no statistically significant differences between candidate and reference method results or between presumptive and confirmed results for three food matrices and one environmental surface. Results from inclusivity and exclusivity evaluations indicated the test method can accurately detect the target analytes and excluded all nontarget organisms. No differences were observed with the stability or lot-to-lot evaluations. Polyskope 1.0 demonstrated robustness by remaining unaffected by small variations in method parameters, which had no statistically significant effect on the results for all eight variations. Conclusions and Highlights: Polyskope 1.0 was shown to be a specific, highly accurate, and robust method for the detection of Listeria monocytogenes, Salmonella species, non-O157 STECs, and E. coli O157 across four matrices.
- Subjects :
- Analyte
Turkey
Biology
medicine.disease_cause
Escherichia coli O157
Real-Time Polymerase Chain Reaction
Non o157
Poultry
Analytical Chemistry
Listeria monocytogenes
Salmonella
Spinacia oleracea
medicine
Environmental Chemistry
Animals
Multiplex
Food science
Shiga toxin-producing Escherichia coli
Escherichia coli
Pharmacology
Salmonella species
Shiga-Toxigenic Escherichia coli
business.industry
Reproducibility of Results
Food safety
Stainless Steel
Red Meat
Food Microbiology
Cattle
business
Agronomy and Crop Science
Multiplex Polymerase Chain Reaction
Food Science
Subjects
Details
- ISSN :
- 19447922
- Volume :
- 102
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Journal of AOAC International
- Accession number :
- edsair.doi.dedup.....312625e3534ea60d8db8d32f8cc3fbd3