AOAC-RI ERP Micro June 2016

OMAMAN-29 D/ PTM Validation Report 111501 OMA ERP - June 2016 ERP Use Only

a) Probability of Detection (POD).— The proportion of positive analytical outcomes for a qualitative method for a given matrix at a given analyte level or concentration. POD is concentration dependent. Several POD measures can be calculated; POD R (reference method

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POD), POD C

(confirmed candidate method POD), POD CP

(candidate method presumptive

result POD) and POD CC

(candidate method confirmation result POD).

b) Difference of Probabilities of Detection (dPOD).— Difference of probabilities of detection is the difference between any two POD values. If the confidence interval of a dPOD does not contain zero, then the difference is statistically significant at the 5% level.

Principle of the Method

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3M™ Molecular Detection Assay 2 - Listeria is used with the 3M™ Molecular Detection System for the rapid and specific detection of Listeria species in enriched food and

environmental samples.

The 3M Molecular Detection Assays use loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences with high specificity and sensitivity, combined with bioluminescence to detect the amplification. Presumptive positive results are reported in real- time while negative results are displayed after the assay is completed. Presumptive positive results should be confirmed using the laboratory’s preferred method or as specified by local

regulations.

General Information

Listeria is a small, Gram-positive rod that can be found in soil or carried by animals. Many foods have been associated with Listeria contamination: uncooked meats, uncooked vegetables, cantaloupe, pasteurized and unpasteurized milk, and other dairy and processed foods. [5] The resulting illness, listeriosis, from Listeria monocytogenes ingestion is rare but can be fatal. The disease may appear as meningitis in adults and can affect unborn children due to its ability to cross through the placenta. Listeria contamination often occurs post- cooking, before packaging as Listeria can survive longer under adverse environmental conditions that can most other vegetative bacteria that present a concern for the food safety industry. [6] Manufacturing facilities implement sanitation practices and regular surface screening for the presence of Listeria on food contact surfaces to monitor their food production environments. The regular surface screening for non - Listeria monocytogenes species is used as an indicator to monitor for the risk of Listeria monocytogenes contamination and is typically part of a food manufacturing facility’s Hazard Analysis Critical Control Point (HACCP) plan. The 3M MDA 2 - Listeria was developed to provide rapid and specific detection of Listeria in enriched food samples and on food processing

AOAC Research Institute Expert Review Panel Use Only

surfaces.

Materials and Methods

Test Kit Information

a) Kit Name. — Molecular Detection Assay 2 – Listeria