Microbiology-PTM-OMA_Modules_1-5

Product Consistency & Stability: Independent  Stability Study

Qualitative

Quantitative

ID Method

Real time or accelerated

Real time or accelerated

Real time or accelerated

1 lot of kits

1 lot of kits

1 lot of kits

• 10 replicates of target material • 10 replicates of non‐target  material at high level

• 5 replicates of target material at  high level • 5 replicates of target material at  low level • 5 replicates of non‐target  material at high level 5 time points over the shelf life of  the test kit

• 10 target strains • 5 non‐target strains

5 time points over the shelf life of  the test kit

5 time points over the shelf life of  the test kit

POD + CI

Bias & repeatability

# correct results