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Departments of Child Health and Pathology, University of Missouri School of Medicine, 1 Hospital Dr., Columbia, MO 65212.
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Centers for Disease Control and Prevention, Division of Laboratory Sciences, National Center for Environmental Health (F25), 4770 Buford Hwy. NE, Chamblee, GA 30341-3724.
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Brigham & Women’s Hospital, Department of Pathology, Harvard Medical School, Thorn 430, 75 Francis St., Boston, MA 02115.
aAddress correspondence to this author at: Department of Child Health, Room M767, University of Missouri School of Medicine, 1 Hospital Dr., Columbia, MO 65212. Fax 573-884-8823; e-mail LittleR{at}health.missouri.edu.
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 A1c (HbA1c) or equivalent, compared with 50% in 1993. Of laboratories reporting HbA1c 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 HbA1c was within 0.8% HbA1c of the NGSP target at all HbA1c concentrations.
Summary: The majority of laboratories in the US are now reporting results that are traceable to DCCT/UKPDS outcomes.
The following articles in journals at HighWire Press have cited this article:
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  C. Weykamp, W G. John, A. Mosca, T. Hoshino, R. Little, J.-O. Jeppsson, I. Goodall, K. Miedema, G. Myers, H. Reinauer, et al. The IFCC Reference Measurement System for HbA1c: A 6-Year Progress Report Clin. Chem., February 1, 2008; 54(2): 240 - 248. [Abstract] [Full Text] [PDF]
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 Consensus Committee Consensus Statement on the Worldwide Standardization of the Hemoglobin A1C Measurement: The American Diabetes Association, European Association for the Study of Diabetes, International Federation of Clinical Chemistry and Laboratory Medicine, and the International Diabetes Federation Diabetes Care, September 1, 2007; 30(9): 2399 - 2400. [Full Text] [PDF]
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D. E. Bruns The Clinical Chemist Clin. Chem., August 1, 2007; 53(8): 1562 - 1564. [Full Text] [PDF]
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K. H. Kahler, M. Rajan, G. G. Rhoads, M. M. Safford, K. Demissie, S.-E. Lu, and L. M. Pogach Impact of Oral Antihyperglycemic Therapy on All-Cause Mortality Among Patients With Diabetes in the Veterans Health Administration Diabetes Care, July 1, 2007; 30(7): 1689 - 1693. [Abstract] [Full Text] [PDF]
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W. H. Herman Diabetes Epidemiology: Guiding Clinical and Public Health Practice: The Kelly West Award Lecture, 2006 Diabetes Care, July 1, 2007; 30(7): 1912 - 1919. [Full Text] [PDF]
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 M. Reiter, S. Wirth, A. Pourazim, S. Puchner, M. Baghestanian, E. Minar, and R. A. Bucek Skin tissue cholesterol is not related to vascular occlusive disease Vascular Medicine, May 1, 2007; 12(2): 129 - 134. [Abstract] [PDF]
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D. M. Nathan, J. B. Buse, M. B. Davidson, R. J. Heine, R. R. Holman, R. Sherwin, and B. Zinman Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes Diabetes Care, August 1, 2006; 29(8): 1963 - 1972. [Full Text] [PDF]
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 M. S. Faulkner, L. Quinn, J. H. Rimmer, and B. H. Rich Cardiovascular Endurance and Heart Rate Variability in Adolescents With Type 1 or Type 2 Diabetes Biol Res Nurs, July 1, 2005; 7(1): 16 - 29. [Abstract] [PDF]
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D. B. Sacks and for the ADA/EASD/IDF Working Group of the HbA1c As Global Harmonization of Hemoglobin A1c Clin. Chem., April 1, 2005; 51(4): 681 - 683. [Full Text] [PDF]
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M. Steffes, P. Cleary, D. Goldstein, R. Little, H.-M. Wiedmeyer, C. Rohlfing, J. England, J. Bucksa, M. Nowicki, and the DCCT/EDIC Research Group Hemoglobin A1c Measurements over Nearly Two Decades: Sustaining Comparable Values throughout the Diabetes Control and Complications Trial and the Epidemiology of Diabetes Interventions and Complications Study Clin. Chem., April 1, 2005; 51(4): 753 - 758. [Abstract] [Full Text] [PDF]
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 C.-L. Tseng, M. Brimacombe, M. Xie, M. Rajan, H. Wang, J. Kolassa, S. Crystal, T.-C. Chen, L. Pogach, and M. Safford Seasonal Patterns in Monthly Hemoglobin A1c Values Am. J. Epidemiol., March 15, 2005; 161(6): 565 - 574. [Abstract] [Full Text] [PDF]
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R. R. Little, H. Vesper, C. L. Rohlfing, M. Ospina, S. Safar-Pour, and W. L. Roberts Validation by a Mass Spectrometric Reference Method of Use of Boronate Affinity Chromatography to Measure Glycohemoglobin in the Presence of Hemoglobin S and C Traits Clin. Chem., January 1, 2005; 51(1): 264 - 265. [Full Text] [PDF]
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N. Rifai, G. R. Cooper, W. V. Brown, W. Friedewald, R. J. Havel, G. L. Myers, and G. R. Warnick Clinical Chemistry Journal Has Contributed to Progress in Lipid and Lipoprotein Testing for Fifty Years Clin. Chem., October 1, 2004; 50(10): 1861 - 1870. [Full Text] [PDF]
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D. E. Goldstein, R. R. Little, R. A. Lorenz, J. I. Malone, D. Nathan, C. M. Peterson, and D. B. Sacks Tests of Glycemia in Diabetes Diabetes Care, July 1, 2004; 27(7): 1761 - 1773. [Full Text] [PDF]
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 B. L Armor and M. L Britton Diabetes Mellitus Non-Glucose Monitoring: Point-of-Care Testing Ann. Pharmacother., June 1, 2004; 38(6): 1039 - 1047. [Abstract] [Full Text] [PDF]
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 J L Camargo and J L Gross Conditions associated with very low values of glycohaemoglobin measured by an HPLC method J. Clin. Pathol., April 1, 2004; 57(4): 346 - 349. [Abstract] [Full Text] [PDF]
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W. Hoelzel, C. Weykamp, J.-O. Jeppsson, K. Miedema, J. R. Barr, I. Goodall, T. Hoshino, W. G. John, U. Kobold, R. Little, et al. IFCC Reference System for Measurement of Hemoglobin A1c in Human Blood and the National Standardization Schemes in the United States, Japan, and Sweden: A Method-Comparison Study Clin. Chem., January 1, 2004; 50(1): 166 - 174. [Abstract] [Full Text] [PDF]
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Tests of Glycemia in Diabetes Diabetes Care, January 1, 2004; 27(90001): s91 - 93. [Full Text] [PDF]
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D. B. Sacks Hemoglobin Variants and Hemoglobin A1c Analysis: Problem Solved? Clin. Chem., August 1, 2003; 49(8): 1245 - 1247. [Full Text] [PDF]
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S. S. Anand, F. Razak, V. Vuksan, H. C. Gerstein, K. Malmberg, Q. Yi, K. K. Teo, and S. Yusuf Diagnostic Strategies to Detect Glucose Intolerance in a Multiethnic Population Diabetes Care, February 1, 2003; 26(2): 290 - 296. [Abstract] [Full Text] [PDF]
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I. Sakurabayashi, T. Watano, S. Yonehara, K. Ishimaru, K. Hirai, T. Komori, and M. Yagi New Enzymatic Assay for Glycohemoglobin Clin. Chem., February 1, 2003; 49(2): 269 - 274. [Abstract] [Full Text] [PDF]
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S. H. Saydah, D. Byrd-Holt, and M. I. Harris Projected Impact of Implementing the Results of the Diabetes Prevention Program in the U.S. Population Diabetes Care, November 1, 2002; 25(11): 1940 - 1945. [Abstract] [Full Text] [PDF]
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R. Hanas Psychological Impact of Changing the Scale of Reported HbA1c Results Affects Metabolic Control Diabetes Care, November 1, 2002; 25(11): 2110 - 2111. [Full Text] [PDF]
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P. Luraschi, S. Brambilla, R. Mozzi, G. Cattozzo, and C. Franzini Monitoring Analytical Quality in Routine Glycohemoglobin Measurements Clin. Chem., September 1, 2002; 48(9): 1594 - 1597. [Full Text] [PDF]
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L. D. Youngman, S. Clark, S. Manley, R. Peto, and R. Collins Reliable Measurement of Glycated Hemoglobin in Frozen Blood Samples: Implications for Epidemiologic Studies Clin. Chem., September 1, 2002; 48(9): 1627 - 1629. [Full Text] [PDF]
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T Lahousen, R E Roller, R W Lipp, and W J Schnedl Silent haemoglobin variants and determination of HbA1c with the HPLC Bio-Rad Variant II J. Clin. Pathol., September 1, 2002; 55(9): 699 - 703. [Abstract] [Full Text] [PDF]
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D. B. Sacks, D. E. Bruns, D. E. Goldstein, N. K. Maclaren, J. M. McDonald, and M. Parrott Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus Clin. Chem., March 1, 2002; 48(3): 436 - 472. [Abstract] [Full Text] [PDF]
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