The National Glycohemoglobin Standardization Program: A five-year progress report

Background: The Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) demonstrated conclusively that risks for complications in patients with diabetes are directly related to glycemic control, as measured by glycohemoglobin (GHB). In 1994, one year after the DCCT results were reported, the American Diabetes Association (ADA) set specific diabetes treatment goals. However, 1993 College of American Pathologists (CAP) Survey results indicated a lack of comparability of GHB test results among methods and laboratories that represented a major obstacle to meaningful implementation of the ADA guidelines. Thus, an AACC subcommittee was formed in 1993 to develop a standardization program that would enable laboratories to report DCCT-traceable GHB results. This program was implemented in 1996 by the National Glycohemoglobin Standardization Program (NGSP) Steering Committee. Approach: We review the NGSP process and summarize progress in standardization through analysis of CAP data. Content. Since 1996, the number of methods and laboratories certified by the NGSP as traceable to the DCCT has steadily increased. CAP GH2-B survey results reported in December 2000 show marked improvement over 1993 data in the comparability of GHB results. In 2000,90% of surveyed laboratories reported GHB results as hemoglobin A(1c) (HbA(1c)) or equivalent, compared with 50% in 1993. Of laboratories reporting HbA(1c) in 2000, 78% used a NGSP-certified method. For most certified methods in 2000, between-laboratory CVs were <5%. For all certified methods in 2000, the mean percent HbA(1c) was within 0.8% HbA(1c) of the NGSP target at all HbA(1c) concentrations. Summary: The majority of laboratories in the US are now reporting results that are traceable to DCCT/UK-PDS outcomes. (C) 2001 American Association for Clinical Chemistry.