Can the manufacturer of an ASR help with the validation and verification of performance specifications of a test that utilizes its ASR?
If a manufacturer or distributor wishes to market its product as an ASR, it should not assist with the development or validation of an LDT using its specific ASR. Under the CLIA regulations, the laboratory must conduct validation and verification of test performance specifications. 42 CFR 493.1213. This validation by the laboratory is the minimum requirement under CLIA for the laboratory to generate clinical results for tests of high complexity.
Related Questions
- Can the manufacturer of an ASR help with the validation and verification of performance specifications of a test that utilizes its ASR?
- Is the Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies validated?
- How many runs have to be performed for the Performance Verification Test?
