Validating high complexity lab test methods speed dating nyc 40s
The QC and calibration requirements of CLIA have been in effect for over 10 years [1,2].All are based on test method complexity or difficulty to perform the testing.
These tests include additional patient population ranges, more runs on accuracy and precision from multiple analysts/reagent lots/instruments, selectivity and specificity tests using patient samples, and stability tests subjected to conceivable conditions over long-term use.CLS will be required to maintain laboratory standards that meet CLIA, CAP and other relevant regulatory authority requirements. Congress passed CLIA to ensure accurate, reliable, and timely test results regardless of testing location.In this review, a fit-for-purpose method validation approach is discussed that fulfills the needs of exploratory and advanced applications in both the pharmaceutical and diagnostic arenas.Method validation for protein biomarkers is typically applied to ligand binding assays (LBA) although hyphenated mass spectrometric methods can be used as adjunct methodologies to confirm LBA specificity or provide valuable information during early discovery or demonstrative phases of a novel biomarker.
Search for validating high complexity lab test methods:
CLS will be responsible for implementing, testing and validating high complexity, high-throughput next generation sequencing assays in our Clinical Genomics Laboratory.