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1. wl ol 1 1 0 OO 2 5 14 0 NGSP 2 5 ei gt aa lt gt HbA1c 2 5 HbF HbA1c 14 02. 2 3 ae 4 a 4 6 6 2 7 HbA1c 1 DCA2000 DCA HbA1c 7 24g dL 7g dL 24g dL F FE 10
3. 3 a b 2 3 DCA2000 DCA DCA2000 HbAic 4 DCA2000 DCA i I NGSP DCCT NGSF
4. 2 8 C 2 8 15 30 24 1 10 5035KC 1 Craine J E Latex agglutination immunoassays American 2 3 4 5 6 7 a 8 9 be 10 11 12 13 14 15 Laboratory 34 May June 1987 Knowles B J Haigh W B Michaud G C and Marchesi V T A monoclonal antibody based immunoassay for hemoglobin Alc Diabetes 35 1986 Suppl 94A Weykamp C W Pender T J Muskiet F J and Van der Silk W Influence of hemoglobin variants and derivatives on glycohemoglobin determinations as investigated by 102 laboratories using 16 methods Clin Chem 39 1993 1717 1722 Eaton S E Fielden P and Haisman P Glycated haemoglobin HbAlc measurements in subjects with haemoglobin variants using the DCA 2000 Ann Clin Biochem 34 1997 2
5. 3 1 DCA2000HbAic HIV HBV HCV
6. 348 1 lt 8 GLP Good Laboratory Practice GLP
7. 10 F HhbA1c HHDS HbC HbA1c HbAlc A0 8 NN 2 9 A1c HbA1c 2 1D HbA1c HbA1c lt 12 13
8. NN 2 5 6 5 6 DCA2000 DCA HbA1c DCA2000 DCA
9. 0 6mL Aic HbAic HbA1c Hb HbA1c AI el 4 YY 4 Hb HbAlc 531nm HbAlc HbAic HbAic 531nm
10. HbA1c HbA1c No Runs No Assays Normal 1 5 2 4 95 21 42 Normal 2 5 2 5 10 22 44 Normal 3 5 2 5 11 22 44 Abnormal 1 11 9 11 32 21 42 Abnormal 2 11 9 11 86 22 44 Abnormal 3 11 9 11 81 22 44 SD C V S D C V Normal 1 0 16 3 3 Normal 2 0 11 2 2 0 06 1 2 Normal 3 0 12 2 3 0 06 1 1 Abnormal 1 0 34 3 0 Abnormal 2 0 33 2 8 0 51 4 3 Abnormal 3 0 44 3 7 0 11 0 9 CLSI NGSP 3 HbA1c 3 8 14 0 NGSP DCA2000 wy x n 1 HPLC 50 YY 0 91x 0 26 0 98 1 HPLC 50 0 94x 0 00 0 98 2 HPLC 47 0 89x 0 42 0 98 2 HPLC 47 0 91x 0 34 0 97 3 HPLC 49 0 94x 0 34 0 98 3 HPLC 50 y 0 91x 0 58 0 97 4 HPLC 100 y 1 02x 0 00 0 98 Diabetes Control and Complications Trial DCCT
11. HbA1c The Diabetes Control and Complications Trial DCCT 9 HbA1c Aic 2 0 15 0 NGSP 0 5 1 6 2 Daily Bias X100 4 3 95 12 4 HbAic 2 5 14 0 2 3 2
12. 3 EDTA 25 1 2 20mg dL 1 347mg dL 1 5 120 3 1 lt A 8 N Ne or
13. 9 CLSI NGSP 4 NGSP IECC SIEIMIENS 1 HIV HBV HCV SI 2 os DP 2 8 C
14. HbS1c HbC1c HbE1c N 6 HbS HbC 26 HbE HbA1c 2 2 Pre HbA1c HbA1c HbDA1c 3 eC TR NN 9 70 5 2 1 1 IN
15. HbA1c 4 591nm FHbA1c HbA1c HbA1c HbA1c Hb X100 DCA2000 DCA HbA1c HbAic 0 te 2 HbAic HbAlc x ii OR 5M 1 1 1 EDTA
16. 05 207 Rose A Tongate C and Valdes Jr R A hemoglobin Alc immunoassay method not affected by carbamylated hemoglobin Ann Clin Lab Science 25 1995 13 19 Weykamp C W Miedema K de Haan T and Doelman C J A Carbamylated Hemoglobin Interference in Glycohemoglobin Assays Clin Chem 45 1999 438 440 2012 2013 1 9 Mayer T K and Freedman Z R Protein glycosylation in diabetes mellitus A review of laboratory measurements and of therr clinical utility Clin Chem Acta 127 1983 147 184 Baynes J W Bunn H F and Goldstem D E et al National Diabetes Data Group Report of the Expert Committee on Glucosylated Hemoglobin Diabetes Cg7e 7 1984 602 606 Koenig R J Peterson C M and Kilo C et al Hemoglobin Aic as an indicator of the degree of glucose intolerance in diabetes Diabetes 25 1976 230 232 Nathan D M Singer D E Hurxthal K and Goodson J D The chnical information Value of the glycosylated hemoglobin assay N Eng J Med 310 1984 341 346 Larsen M L Horder M and Mogensen E F Effect of long term monitoring of glycosylated hemoglobin levels in insulin dependent diabetes melhtus N Eng J Med 323 1990 1021 1023 Nathan D M Hemoglobin Alc Infatuation or the real thing N Eng J Med 323 1990 1062 1063 DCCT Research Group The effect of intensive tre
17. IN a i 5 0 0 1 3 4 Cg K2 DCA 2000 HbAic 2 2 1
18. atment of diabetes on the development and progresslon of long term complications in insuln dependent diabetes mellitus N Eng Med 329 1993 977 986 Bodor G S Little R R Garrett N Brown W Goldstein D E and Nahm M H Standardizanon of glycohemoglobin determinations in the chnical laboratory Three Years of Experience Clin Chem 38 1992 2414 2418 03 3493 8400 1 11 1 www siemens com diagnostics 10888670 84424723 Rev C 2014 06 Ref 83449439 Rev A 2011 03
19. x x 13A2X10031000030 2014 4 6 2013 4 5 Aic DCA 2000 HbAic 1 2 3 4 5 10 11 1 NGSP 1 Aic 2 3
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