糖化ヘモグロビン（HbA1c）自動免疫測定試薬の開発

1 71. HbA1c . AIA G .. ST AIA PACK HbA1c . 1.. HbA1c Hb . 2 non enzymatic . 2.. HbA1c . N . HbA1c Schiff base 2 .. HbA1c . 2 2 HbA1c . HbA1c HbA1c HbA1c . HbA1c 100 120 . 1 4 . 1 2 HbA1c . HbA1c HbA1c Total Hb HbA1c . Total Hemoglobin HbA1c HbA1c . HbA1c .. HbA1c .. 40 20. 5 . 12 .. 2 4,600 .. 37 10 . 1 HPLC HbA1c . HbA1c B F . HLC 723 4 4 MUP . 4 . 2300 4MU . ADA American Diabetes . Association HbA1c HbA1c . HbA1c HbA1c . HbA1c HbA1c . HPLC HbA1c .. AIA 360 AIA 600II HbA1c B F . 71 . 72 TOSOH Research Technology Review 2008 . Free .. Bound Hb . B F A1c HbA1c . 4 MUP .. 4MU . HbA1c . 6 . 18 . 50 . 20 . AIA . HbA1c . 3. AIA .. HPLC . 4.. HLC 723G7 . G7 Variant 1 . NGSP 3. National Glycohemoglobin Standardization Program EDTA 3 . Low Middle High 1 . 20 . HbA1c . coefficient of variation CV . AIA 20 90 4 .. CV .. Coefficient Sample Mean Pooled SD of Variation HbA1c . HWB Low HWB Middle . HWB High .. S . 6 Glu Val13 C 6 Coefficient 14 Sample Mean Pooled SD of Variation Glu Lys E 26.

2 HbA1c . 15 . Glu Lys D 121 Glu HWB Low 16 HWB Middle Gln . HWB High N 5 . 72 . 52 2008 73. 2 . HbA1c 6 . Expected Value Observed Value Recovery Low High HbA1c HbA1c . MDC Calibrator 1 20 Low Undiluted 9 1 2 SD . 8 2 7 3 6 MDC 6 4 5 5 4 6 3 7 2 8 1 9 High Undiluted Y Ax 3 Bx 2 Cx D. Rate Func A 02. Func B 01. Func C 01 EDTA NaF. Func D 01.. EDTA . 10 .. A1c EDTA . 1,000 mg dL . Conc 50 mg dL .. 50 mg dL . (MDC 37 4 . EDTA 10 . HbA1c MDC. lot HbA1c .. GZ15759 . H115760 H115761 H115762 H615764 . H615765 . mg dL 16. mg dL 18. 3 . mg dL 1,600. Total Hb g dL mg mL 50. mg dL 20. HbA1c HbA1c . EDTA mg mL 10. 3 mg mL 10.. HbA1c .. 4 mg dL 1,000. mg dL 50.. mg dL 50. EDTA EDTA . 37 4 . 17 18 .. 73 . 74 TOSOH Research Technology Review 2008 . 5 NGSP . HbA1c . IFCC International Federation of Clinical Chemistry IFCC NGSP . and Laboratory Medicine JDS NGSP HbA1c IFCC HbA1c .. NGSP National Glycohemoglobin Standardization Program HbA1c Calibrator Set Lot Melbourne NGSP 2007 NGSP . NGSP NGSP.)

3 IFCC HbA1c Calibrator Set .. Lot Melbourne 2007 Reference Material . IFCC NGSP . 6 HPLC . 19 . , 20 . NGSP EDTA 117 G7 Variant IFCC HbA1c Calibrator Set Lot Melbourne 2007 G7 Variant IFCC HbA1c Calibrator Set . IFCC NGSP NGSP . HbA1c IFCC HbA1c NGSP HbA1c NGSP Recovery . IFCC Cal Level 1 IFCC Cal Level 2 IFCC Cal Level 3 IFCC Cal Level 4 IFCC Cal Level 5 IFCC Cal Level 6 IFCC Cal Level 7 IFCC Cal Level 8 ST AIA PACK HbA1c CALIBRATOR SET Traceability Chain Materials Calibration Methods Assignment Reference material IFCC HbA1c Calibrator set Lot Melbourne 2007 . NGSP .. NGSP. HbA1c IFCC. HbA1c TOSOH HbA1c 1 . TOSOH HbA1c 2 TOSOH HbA1c 1 AIA . TOSOH HbA1c 2 . TOSOH HbA1c TOSOH HbA1c 2 AIA . TOSOH HbA1c . HbA1c . 74 . 52 2008 75. x y r NaF EDTA 2. y .. EDTA. 7 EDTA NaF NaF EDTA . EDTA EDTA x NaF+EDTA y 63. HbA1c EDTA r .. NaF EDTA . 16. y EDTA . r n 117 . 8 . 12 . HbA1c .. S C .. S C G7 Variant . 8. G7 Variant . 20 .. 9 . 4 Total Hb 12 18. 4 8 12 16. g dL Total Hb 10 g . G7 Variant HbA1c dL.

4 Total Hb . ST AIA PACK HbA1c G7 Variant . 91 . S C . G7 Variant G7 Variant Specimen HbA1c HbA1c Recovery . A S Variant 001 A S Variant 002 A S Variant 003 A S Variant 004 A S Variant 005 A S Variant 006 A S Variant 007 A S Variant 008 A S Variant 009 A S Variant 010 A S Variant 011 A S Variant 012 A S Variant 013 A S Variant 014 A S Variant 015 A S Variant 016 A S Variant 017 A S Variant 018 A S Variant 019 A S Variant 020 A S Variant 021 A S Variant 022 A S Variant 023 A C Variant 001 A C Variant 002 75 . 76 TOSOH Research Technology Review 2008 . G7 Variant . 12. y . r n 63 S C . G7 Variant 20 . EDTA with NaF whole blood 10.. AIA . HbA1c . 8.. 6.. Mayer TK., et al, Clin. Chem. Acta.,127, 147. 4 1983 .. 4 6 8 10 12. Bunn H. F., et al, Biochem. Biophysi. Res. EDTA Whole Blood HbA1c Conmun., 19, 103 1975 . Bunn H. F., et al, J. Clin. , 57, 1652 1976 .. EDTA NaF . EDTA Baynes J. W., et al, Diabetes Care, 7, 602 1984 . Rochman H., et al, Ann. Clin. Lab. ,10, 111. 1980 .. Diabetes Control and Complications Trial G7 Variant.

5 40. Research Group, N. Engl. J. , 329, 977. 20. 1993 .. Bias 0. Larsen ML., et al, N. Engl. J. , 323, 1062. 20 1990 .. Koenig R. J.,et al, Diabetes., 25, 230 (1976). 40. 6 8 10 12 14 16 18 Nathan D. M., et al, N. Eng. J. Med., 310, 341. Hemoglobin Concentration g dL . 1984 .. 10 DCCT Reseach Group., N. Eng. J. , 329, 977. Total Hb . 1993 .. 11 Larsen M. L., et al, N. Eng. J. Med., 323, 1021. Total Hb g dL G7 1990 .. Variant 12 Nathan D. M., et al, N. Eng. J. , 323, 1062. G7 Variant 1990 .. 20 13 Ingram V. M., et al, Biochem. Biophys. Acta., 36, 402 1959 .. 14 Hunt J. A., et al, Biochem. Biophys. Acta., 42, 409. 5.. 1960 .. HbA1c 15 Hunt J. A., et al, Biochem. Biophys. Acta., 49, 520. 1961 .. 16 Harano T., et al, Hemoglobin, 11, 177 1987 . 17 Tetsuo M., et al, JJCLA., 23, 691 1998 . 18 20 274 1997 .. EDTA NaF EDTA 19 Gas W., et al, Clin. Chem., 54, 240 2008 . 20 Andrea G., et al, Clin. Chem., 54, 1379 2008 .. NGSP . 76.