Chemistry-PTM-OMA_Modules_1-4

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 a single material (e.g., matrix, reference  standards, reference material, calibration standards)  • Twenty (20) total replicates evaluated for each lot.   • 10 replicates of the target analyte at a fractional level (2‐8) • 10 replicates of blanks • Test in a randomized blind coded fashion. • Decode, calculate POD values and confidence intervals and analyze  data for variable detection between lots/time points.

Qualitative 3 lots of kits • 10 replicates of target material at low level • 10 replicates of blanks

POD + CI