Microbiology-PTM-OMA_Modules_1-5

Product Consistency & Stability: Combined Real‐ Time Study Design for Identification 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, matrix, DNA, etc.  • Fifteen (15) total replicates evaluated for each lot.   • 10 of the target analyte • 5 of the non‐target analyte • Test in a randomized blind coded fashion. • Decode results and determine number of correct  identification 

ID Method 3 lots of kits

• 10 target strains • 5 non‐target strains # correct results