Statistical methods for monitoring the relationship between the IFCC reference measurement procedure for hemoglobin A1c and the designated comparison methods in the United States, Japan, and Sweden

Clinical Chemistry

Volumn 54, Issue 8, 2008, Pages 1379-1385

  Geistanger, Andrea ^a   Arends, Sabine ^a   Berding, Christoph ^a   Hoshino, Tadao ^b   Jeppsson, Jan Olof ^c   Little, Randie ^d   Siebelder, Carla ^e   Weykamp, Cas ^e  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

^b Institute of Biopathological Medicine   (Japan)

^c LUND UNIVERSITY HOSPITAL   (Sweden)

^d University of Missouri   (United States)

^e Queen Beatrix Hospital   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; INTERMETHOD COMPARISON; JAPAN; MATHEMATICAL PARAMETERS; REFERENCE VALUE; STATISTICAL ANALYSIS; SWEDEN; UNITED STATES;

CLINICAL CHEMISTRY TESTS; DATA INTERPRETATION, STATISTICAL; DIABETES MELLITUS; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; JAPAN; NATIONAL HEALTH PROGRAMS; PRACTICE GUIDELINES AS TOPIC; REFERENCE STANDARDS; SWEDEN; UNCERTAINTY; UNITED STATES;

EID: 48949103005     PISSN: 00099147     EISSN: None     Source Type: Journal    
DOI: 10.1373/clinchem.2008.103556     Document Type: Article

References (20)

1. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
2. American Diabetes Association. Standards of medical care in diabetes - 2007. Diabetes Care 2007;30:S4-41.
3. Little RR, Rohlfing CL, Wiedmeyer HM, Myers GL, Sacks DB, Goldstein DE. The National Glycohemoglobin Standardization Program: a five-year progress report. Clin Chem 2001;47:1985-92.
4. 1c Determination, the Japan Diabetes Society. J Jpn Diabetes Soc 1994;37:855-64.
5. 1c by a new liquid chromatographic assay: methodology, clinical utility and relation to glucose tolerance evaluated. Clin. Chem 1986;32:1867-72.
6. 1c in human blood. Clin Chem Lab Med 2002;40:78-89.
7. Consensus Committee. Consensus Statement on the Worldwide Standardization of the Hemoglobin A1C Measurement: American Diabetes Association, European Association for the Study of Diabetes, International Federation of Clinical Chemistry and Laboratory Medicine, and International Diabetes Federation. Diabetes Care 2007;30:2399-400.
8. Hoelzel W, Weykamp C, Jeppsson JO, Miedema K, Barr J, Goodall I, 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 2004;50:166-74.
9. Kobold U, Jeppsson JO, Duelffer T, Finke A, Hoelzel W, Miedema K. Candidate reference methods for hemoglobin A1c based on peptide mapping. Clin Chem 1997;43:1944-51.
10. 1c: a 6-year progress report. Clin Chem 2008;54:240-8.
11. 1c Determination, 2000.
12. National Glycohemoglobin Standardization Program. http://www.NGSP.org (Accessed May 27, 2008).
13. ISO/IEC Guide 98:1995, Guide to the Expression of Uncertainty in Measurement (GUM). Geneva: International Standards Organization, 1995.
14. Ripley B, Thompson M. Regression techniques for the detection of analytical bias. Analyst 1987;112:377- 83.
15. Linnet K. Evaluation of regression procedures for method comparison studies. Clin Chem 1993;39:424-32.
16. Linnet K. Performance of Deming regression analysis in case of misspecified analytical error ratio in method comparison studies. Clin Chem 1998;44:1024-31.
17. NCCLS document EP9 -A2, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, 2nd ed. Wayne, PA: NCCLS, 2002.
18. Liu W, Jamshidian M, Zhang Y. Multiple comparison of several linear regression models. JASA 2004;99:395-403.
19. Report of the ADA/EASD/IDF Working Group of the HbA1c Assay, January 20, 2004. London: EASD News Section, 5/2004.
20. Panteghini M, John WG. Implementation of haemoglobin A1c results traceable to the IFCC reference system: the way forward. Clin Chem Lab Med 2007;45:942- 4.