Abstract
The objective of this work was a correct statistical comparison of two assay methods for determination of glycated haemoglobin HbA1c. The immunoturbidimetric determination of HbA1c was performed in two ways: using an automatic analyser Hitachi 912, calibrated according to the IFCC reference system (International Federation of Clinical Chemistry and Laboratory Medicine) and using an analyser Advia 1200 and the NGSP reference system (National Glycohaemoglobin Standardization Program). For statistical comparison of these two analytical methods several advanced regression methods were used, which respect random errors of both compared methods. Specifically, Deming regression with and without weights, orthogonal regression, and Passing-Bablok regression were employed. The results demonstrate that the investigated analytical assay methods do not correspond to each other. The summarized results indicate usefulness of better harmonisation of two existing reference systems.
[1] D.B. Sacks, Clin. Chem. 49, 1245 (2003) http://dx.doi.org/10.1373/49.8.124510.1373/49.8.1245Search in Google Scholar PubMed
[2] A. Lapolla, P. Traldi, D. Fedele, Clin. Biochem. 38, 103 (2005) http://dx.doi.org/10.1016/j.clinbiochem.2004.09.00710.1016/j.clinbiochem.2004.09.007Search in Google Scholar PubMed
[3] M. Penttilä, T. Halonen, K. Punnonen, U. Tiikkainen, Scand. J. Clin. Lab. Invest. 65, 453 (2005) http://dx.doi.org/10.1080/0036551051002580910.1080/00365510510025809Search in Google Scholar PubMed
[4] S. Manley, W.G. John, S. Marshall, Diabet. Med. 21, 673 (2004) http://dx.doi.org/10.1111/j.1464-5491.2004.01311.x10.1111/j.1464-5491.2004.01311.xSearch in Google Scholar PubMed
[5] Consensus Committee: J. Hicks, M. Muller, M. Panteghini, G. John, L. Deeb, J. Buse, D.M. Nathan, R. Kahn, E. Ferrannini, R. Heine, M. Silink, J.C. Mbanya, Diabetes Care 30, 2399 (2007) http://dx.doi.org/10.2337/dc07-992510.2337/dc07-9925Search in Google Scholar PubMed
[6] A. Geistanger, S. Arends, Ch. Berding, T. Hoshino, J.O. Jeppsson, R. Little, C. Siebelder, C. Weykamp, Clin. Chem. 54, 1379 (2008) http://dx.doi.org/10.1373/clinchem.2008.10355610.1373/clinchem.2008.103556Search in Google Scholar PubMed
[7] J.O. Jeppsson, U. Kobold, J. Barr, A. Finke, W. Hoelzel, T. Hoshino, K. Miedema, A. Mosca, P. Mauri, R. Paroni, L. Thienpont, M. Umemoto, C. Weykamp, Clin. Chem. Lab. Med. 40, 78 (2002) http://dx.doi.org/10.1515/CCLM.2002.01610.1515/CCLM.2002.016Search in Google Scholar PubMed
[8] H.G. Schneider, I. Goodall, P.G. Colman, M. McLean, G. Barker, Int. Med. J. 37, 213 (2007) http://dx.doi.org/10.1111/j.1445-5994.2006.01302.x10.1111/j.1445-5994.2006.01302.xSearch in Google Scholar PubMed
[9] K. Paisooksantivatana, A. Kongsomgan, L. Leohirun, K. Atamasirikul, M. Kunakorn, Diabetes Res. Clin. Pract. 83, 43 (2009) http://dx.doi.org/10.1016/j.diabres.2008.11.02810.1016/j.diabres.2008.11.028Search in Google Scholar PubMed
[10] K. Paisooksantivatana, A. Kongsomgan, K. Khupulsup, Diabetes Res. Clin. Pract. 85, 22 (2009) http://dx.doi.org/10.1016/j.diabres.2009.06.00510.1016/j.diabres.2009.06.005Search in Google Scholar PubMed
[11] W. Hoelzel, C. Weykamp, J.O. Jeppsson, K. Miedema, J.R. Barr, I. Goodall, T. Hoshino, W.G. John, U. Kobold, R. Little, A. Mosca, P. Mauri, R. Paroni, F. Susanto, I. Takei, L. Thienpont, M. Umemoto, H.M. Wiedmeyer, Clin. Chem. 50, 166 (2004) http://dx.doi.org/10.1373/clinchem.2003.02480210.1373/clinchem.2003.024802Search in Google Scholar PubMed
[12] Roche Diagnostics GmbH D-M, Cobas Integra 400/700/800: Hemoglobin A1C hemolysate application standardized according to IFCC (Roche Diagnostics Corporation, Indianapolis, IN, USA, 2002) Search in Google Scholar
[13] J. Mocak, B. Balla, A. Bobrowski, P. Blazicek, Chem. Pap. 57, 143 (2003) Search in Google Scholar
[14] K. Linnet, Clin. Chem. 39, 424 (1993) 10.1093/clinchem/39.3.424Search in Google Scholar
[15] H. Passing, W. Bablok, J. Clin. Chem. Clin. Biochem. 21, 709 (1983) Search in Google Scholar
[16] H. Passing, W. Bablok, J. Clin. Chem. Clin. Biochem. 22, 431 (1984) Search in Google Scholar
[17] W. Bablok, H. Passing, R. Bender, B. Schneider, J. Clin. Chem. Clin. Biochem. 26, 783 (1988) 10.1515/cclm.1988.26.11.783Search in Google Scholar PubMed
[18] J.M. Bland, D.G. Altman, Stat. Methods Med. Res. 8, 135 (1999) http://dx.doi.org/10.1191/09622809967381927210.1191/096228099673819272Search in Google Scholar
[19] Analyse-it for Microsoft Excel ver. 2.12 (Analyse-it Software, Ltd., United Kingdom, 1997–2010) http://www.analyse-it.com Search in Google Scholar
[20] Medcalc ver. 10.4.0.0. (MedCalc Software bvba, Mariakerke, Belgium, 2005–2010) http://medcalc.be Search in Google Scholar
[21] JMP 8 (SAS Institute Inc., Cary, NC, USA, 2005) http://jmp.com Search in Google Scholar
[22] K. Linnet, Clin. Chem. 45, 882 (1999) 10.1093/clinchem/45.6.882Search in Google Scholar
[23] G.S. Dhatt, M.M. Agarwal, B. Bishawi, Clin. Chim. Acta 358, 81 (2005) http://dx.doi.org/10.1016/j.cccn.2005.02.00910.1016/j.cccn.2005.02.009Search in Google Scholar PubMed
[24] A. Adamikova, J. Bakala, J. Bernatek, J. Rybka, S. Svacina, Ann. Nuc. Med. 20, 615 (2006) http://dx.doi.org/10.1007/BF0298465910.1007/BF02984659Search in Google Scholar PubMed
[25] J.M. Bland, D.G. Altman, Lancet 307 (1986) Search in Google Scholar
[26] D. Stöckl, K. Dewitte, L.M. Thienpont, Clin. Chem. 44, 2340 (1998) 10.1093/clinchem/44.11.2340Search in Google Scholar
© 2010 Versita Warsaw
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.