How does an A1C testing method become NGSP certified?
The certification process includes the exchange of 40 patient samples and an assessment of agreement analysis. A certificate of traceability to the Diabetes Control and Complications Trial (DCCT) Reference Method is issued to any manufacturer or laboratory that successfully completes the certification process. The certificate is effective for 1 year and is specific to the reagents and instrumentation used during certification. The process consists of a 40 sample comparison with a Secondary Reference Laboratory (SRL). In order for a commercial method to be considered traceable to the Central Primary Reference Library, the 95% CI of the differences between methods (test method and SRL method) must fall within the clinically significant limits of ±0.85% A1C.
