Guideline References

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures

The primary standard governing LoB, LoD, and LoQ evaluation. EP17-A2 specifies the power model approach for LoQ determination, minimum study design requirements (2 reagent lots, 3 days, 3 replicates per sample per reagent-day-run combination, 4 low-level samples, 36 total replicates per lot), and the protocol for comparing results against manufacturer LoQ claims.

Accreditation and Regulatory Requirements

CAP and CLIA require clinical laboratories to establish or verify the lower limit of the reportable range for quantitative non-waived tests. The LoQ defines this lower boundary and must be documented as part of the method's performance specifications.