Microbiology-PTM-OMA_Modules_1-5

Robustness Study Designs

Method Type

Study Design

Statistics

Qualitative

Artificially contaminated: 10 Replicates Low (fractional positives a ) 10 Replicates Noninoculated or Inoculated with  Background Organism

Probability of Detection  (POD)

Quantitative

5 Replicates High 5 Replicates Low 5 Replicates Noninoculated

Log(10) transform

a Fractional positives are defined as POD = 0.25‐0.75 b dPOD values are calculated using nominal value as the baseline