Microbiology-PTM-OMA_Modules_1-5

PTM and OMA SLV Matrix Study Designs

Method Type Study Design

Statistics

Acceptance Criteria

Qualitative If artificially contaminated: 5 Replicates High (all positive)

Probability of  Detection (POD)

95% CI on dPOD must include 0

20 Replicates Low (fractional positives*) 5 Replicates Noninoculated If naturally contaminated: 2 Lots 20 Replicates/lot One lot must have fractional positive results

Quantitative 5 Replicates High

Log(10) transform

5 Replicates Medium 5 Replicates Low [5 Replicates Noninoculated]

Difference of Means  (DOM) with 95% CI

[In development]

Expert Judgement

S r

*Fractional positives are defined as POD = 0.25‐0.75