Best practices and recommendations for in-house verification of genomic profiling in vitro diagnostic kitted solutions

Key takeaways

• Under CLIA, laboratories must perform either analytical validation or verification for every test, method, or platform before its use in patient testing. While verification and validation both aim to ensure diagnostic tests deliver reliable clinical results, the two differ significantly in their objectives and scope
• The analytical verification process involves evaluating three performance metrics: accuracy, precision and reportable range
• Verification studies should include intended-use specimen types representing a range of tumors and genomic variants
• The number of samples required for verification is at the discretion of the laboratory director but should be ‘adequate’ as per CLIA regulations
• Acceptance criteria should be defined and approved by the laboratory director based on comparable performance data published in the IVD product insert
• IVD-labelled kitted solutions, such as PGDx elio tissue complete and PGDx elio plasma focus Dx, require only verification, providing a streamlined and resource-efficient alternative to full validation
• The verification process for FDA-authorized IVD kitted solutions like PGDx elio tissue complete and PGDx elio plasma focus Dx is crucial for ensuring accurate and reproducible results in CAP/CLIA certified laboratories

Authors

Madison J Kelly, Kenneth C. Valkenburg, Jordan Woodrick, Kai Pollard, Efren Ballesteros, Jennifer Jackson, Aanavi Karandikar