When a Test Is Considered New
A test method is considered new when the laboratory adds a new assay, changes platforms, significantly modifies an existing method, or implements a laboratory-developed test (LDT). CLIA requires evidence that the method performs as intended before reporting patient results.
Verification vs Validation Under CLIA
- Verification: Confirming that a commercially cleared method performs in your lab as the manufacturer claims.
- Validation: Establishing performance characteristics for methods not previously cleared, such as LDTs or significantly modified tests.
Required Performance Characteristics
Depending on the test type, performance studies may include:
- Accuracy (comparison to a reference method or peer instrument).
- Precision (within-run and between-run reproducibility).
- Analytical measurement range and linearity.
- Reference intervals and reportable ranges.
- Analytical sensitivity and specificity.
- Carryover and interference studies.
Documentation Expectations
For each new method, CLIA surveyors expect to see:
- Written validation/verification plan and protocol.
- Raw data and summary analysis.
- Approval by the laboratory director or designee.
- Updated procedure manual reflecting the new method.
How mylabcompliance.io Streamlines New Method Onboarding
mylabcompliance.io simplifies the onboarding of new methods by:
- Providing standardized templates for validation and verification studies.
- Capturing data, approvals, and attachments in one record per method.
- Linking test methods to instruments, reagents, and QC requirements.
- Tracking status of ongoing validations across multiple sites.