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VIDAS LMX & LPT Collaborative Study

April 19, 2013

OMA-2013-Apr-XXX

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8.0

Analyzing Raw Data

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The resulting data will be analyzed by probability of detection (POD).

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8.1

Probability of Detection (POD) -

POD is the proportion of positive analytical

6

outcomes for a qualitative method for a given matrix at a given analyte level or

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concentration. POD is concentration dependent. Please see the revised

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microbiology guidelines

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for complete analysis information on POD calculations.

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8.1.1

Calculate:

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8.1.1.1 Estimate of repeatability - standard deviation (s

r

)

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8.1.1.2 Determine POD values for each matrix and concentration - the

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number of positive outcomes divided by the total number of trials.

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8.1.1.3 Estimate of reproducibility – standard deviation of the laboratory

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POD values (s

POD

) and confidence intervals.

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8.1.1.4 Cross laboratory probability of detection (LPOD) – LPODs by

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matrix and concentration with 95% confidence intervals for

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candidate method (presumptive and confirmed) results.

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8.1.1.5 Difference of cross-laboratory probability of detection (dLPOD) –

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difference probability of detection is the difference between any

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two LPOD values.

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8.1.1.5.1

Estimate dLPOD

C

as the difference between the

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candidate and reference LPOD values, include CIs.

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8.1.1.5.2

Estimate dLPOD

CP

as the difference between the

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presumptive and confirmed LPOD values, include CIs.

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8.1.1.5.3

If the CI of a dLPOD does not contain zero then the

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difference is statistically significant

.

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8.1.1.6 For each matrix, graph POD

R

, LPOD

C

and dLPOD

C

by level with

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95% confidence intervals.

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9.0

Appendices

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9.1

Instructions to Collaborators

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9.2

Test Portion Data Report Form

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9.3

Collaborator Comment Form

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9.4

Study Materials

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9.5

Flow Diagram – Soft Mexican Cheese

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9.6

Collaborator Information Sheet

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AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for

Food

and Environmental Surfaces (pre-publication document, 2012) Sharon Brunelle, Robert LaBudde, Maria Nelson,

and Paul Wehling

DRAFT DOCUMENT

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