Document published by the source itself
EP49 | Framework for Developing Evidence of Clinical Validity of Medical Laboratory Test Methods
CLSI’s framework for building evidence of clinical validity, written for manufacturers and for labs developing their own tests.
Source
CLSI EP49 provides a framework to aid test developers (both manufacturers and laboratories that create laboratory-developed tests [LDTs]) in establishing evidence of clinical validity for medical laboratory test methods using noninterventional clinical performance studies.
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Key takeaways
CLSI’s framework for building evidence of clinical validity, written for manufacturers and for labs developing their own tests.
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-09
2026-10-09
professional use
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