Chemistry-PTM-OMA_Modules_1-4

Product Consistency & Stability: Combined Real‐ Time Study Design for Quantitative Methods

• Three (3) 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, calibration  standards, reference standards, reference material)  • Five (5) test portions evaluated for each lot.   • 5 replicates of the target analyte at a high level • 5 replicates of the target analyte at a low level • 5 replicates of blanks • Test in a randomized blind coded fashion. • Decode results and analyze for effects on bias and repeatability. • Data demonstrating no statistical difference in detection  between lots and no significant time slope are required.

Quantitative 3 lots of kits • 5 replicates of target  analyte at low level • 5 replicates of target  analyte at high level • 5 replicates of blanks Bias & repeatability