Chemistry-PTM-OMA_Modules_1-4

Independent Stability Study

Quantitative

Qualitative

Real time or accelerated

Real time or accelerated

1 lot of kits

1 lot of kits

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

• 10 replicates of target material at  low level • 10 replicates of blanks

5 time points over the shelf life of  the test kit

Bias & repeatability

POD + CI