Guideline References

Multicentre Evaluation of the Premier Hb9210 HbA1c Analyser — Clin Chem Lab Med

The primary methodological reference for the 21-specimen carryover protocol used in this module. The study design — 3 baseline low specimens followed by alternating high/low pairs — and the statistical framework for carryover estimation and confidence interval calculation are derived from this publication and the broader industry-standard carryover assessment literature.

Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures

CLSI EP10 addresses preliminary method evaluation including carryover as one of several performance characteristics. It provides context for carryover assessment within the broader framework of method introduction and verification.