Microbiology-PTM-OMA_Modules_1-5

Product Consistency & Stability: Combined Real‐Time  Study Design for Qualitative Methods • Three lots of test kits  • One lot near the expiration date • One lot near the middle of the expiration period • One lot recently manufactured.  • Conducted using pure culture, inoculated matrix, DNA, etc.  • Twenty (20) total replicates evaluated for each lot.  

Qualitative 3 lots of kits • 10 replicates of target material • 10 replicates of non‐ target material at high  level POD + CI

• 10 replicates of the target analyte at a fractional level (2‐8) • 10 replicates of the non‐target analyte at an undiluted level • Test in a randomized blind coded fashion. • Decode, calculate POD values and confidence intervals and analyze  data for variable detection between lots/time points.