CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. One, accuracy, reproducibility, and transferability of the test result number. Two, a reference range that […]
Need Rigorous Validation For Home Brew Assays
Challenge is for laboratory to verify accuracy, then report results that clinicians easily understand
- By Robert Michel
- > From the Volume XVI No. 3 - February 23, 2009 Issue
- Tags: cap, clia, clia regulation, clia regulations, clia standards, dark report, diagnostic assays, ehi, Esoteric testing, lab industry, lab test, lab testing, lab tests, laboratories, laboratory director, laboratory medicine, laboratory test, laboratory testing, ldt, mass spec, mass spectrometry, new diagnostic technologies, NY labs, pathologists, proficiency testing, tandem mass spectrometry, the dark report, the laboratory
