Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

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OMAMAN-31 E: AOAC RI PTM Report 091501 ERP Use Only - March 2016

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Definitions

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 (the presumptive candidate results that confirmed positive POD), POD CP POD), POD C

(candidate method presumptive result POD) and POD CC

(candidate method confirmation

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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.

c) General Definitions for the MDA 2 - Salmonella

a. RLU: Relative Light Units. RLU is defined as the unit of measurement of Adenosine Triphosphate (ATP). RLU is not a Standard Measurement, such as length (inches/meters) but is specific to each manufacturer. The RLU measurement is detected through the 3M™ Molecular Detection Instrument. b. NC: Negative Control is present in 1 well for each run. The negative control is c. RC: Reagent Control is present in 1 well for each run. The reagent control is always a sterile growth medium and is used to validate that the isothermal amplification has d. MC: Matrix Control is present in 1 well for each run. The matrix control is used to determine if the matrix has the ability to impact the 3M MDA2 - Salmonella results. always a sterile growth medium. worked properly. Salmonella is a motile, non-spore forming, Gram-negative, rod-shaped bacterium in the family Enterobacteriaceae . Non-motile variants include Salmonella Gallinarum and Salmonella Pullorum . The genus Salmonella is divided into two species that can cause illness in humans, Salmonella bongori and Salmonella enterica , the latter being characterized as being the greatest Salmonella species and subspecies are also subdivided into serotypes, based on the Kaufmann- White typing scheme first published in 1934, which differentiates Salmonella strains by their surface and flagellar antigenic properties. Salmonella species are commonly referred to by their serotype names. For example, Salmonella enterica subsp. enterica is further divided into numerous serotypes, including Salmonella Enteritidis and Salmonella Typhimurium, which are Salmonella causes two types of illnesses, gastrointestinal and typhoidal illness. Gastrointestinal illness causes nausea, vomiting, diarrhea, cramps, and fever, with symptoms generally lasting a couple of days and tapering off within a week. Typhoidal illness causes high fever, diarrhea or constipation, body aches, headache, and lethargy (drowsiness or sluggishness), and, sometimes a public health concern. common in the U.S. AOAC Research Institute Expert Review Panel Use Only General Information

04/05/2019