Guideline References

One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test

The primary standard governing performance verification for PT and aPTT assays, including reagent sensitivity characterization. H47-A2 provides guidance on normal range establishment, reagent lot evaluation, and the use of serial dilutions to characterize factor sensitivity.

Standard: Establishment and Verification of Method Performance Specifications

For non-waived coagulation tests, CLIA requires laboratories to verify performance specifications — including sensitivity — for FDA-cleared methods, and to establish sensitivity data for laboratory-developed procedures.