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Need Rigorous Validation For Home Brew Assays

Challenge is for laboratory to verify accuracy, then report results that clinicians easily understand

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 …

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