Validated Assay Kits

MSD’s validated assay kits meet the Clinical Laboratory Standards Institute guidelines for consistency, sensitivity, precision, and robustness. Validation testing is conducted through a design-control process according to the principles outlined in “Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement” by Lee, J.W. et al.

Validation. Bioanalytical and functional characterizations of calibrators, antibodies, and other assay components are completed to ensure quality and consistency of critical reagents between lots. This characterization includes plate coating uniformity and component bridging within control and kit specifications for consistency and lot-to-lot reproducibility. Multiple control sample replicates in the specified matrices are tested to ensure that our assay kits meet MSD’s accuracy, precision, and sensitivity criteria.

Verification. Multi-day analysis with multiple runs per day using 3–9 plates is performed as part of the release testing for each lot.

Validation testing includes:

• Sensitivity
• Dynamic range
• Calibration curve fitting
• Intra-run, inter-plate, and inter-lot precision and accuracy
• Robustness and stability of calibrators, antibodies, and controls
• Specificity, spike recovery, and dilution linearity
• Analysis of normal samples for the specified species to determine the normal range of biomarker concentration detected with the assay
  
  Details are included in each kit’s product insert and certificate of analysis.