Guideline References

Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures

The primary standard governing evaluation of LoB, LoD, and LoQ. EP17-A2 specifies both the nonparametric and parametric methods for calculating the LoB, the minimum experimental design requirements (2 reagent lots, 3 days, 5 blank samples, 5 low-level samples, 4 replicates per sample per reagent-day combination), and the protocol for verifying manufacturer detection capability claims.

Accreditation and Regulatory Requirements

CAP and CLIA require clinical laboratories to verify detection capability for quantitative non-waived tests. Verification records must document the study design, reagent lots tested, raw data, calculated LoB, and comparison against any manufacturer claim.