PDFファイル - 医薬品医療機器総合機構
Contents
1. HO 8 Anti TP 0 NR MP M SA MP 2 1R1 2 TP2. 2 8 20 2 2 1 Anti TP MP 1 2 2 8C 2 8C 8 2010 e 411 20 25 4 5 6000 e601 8000 e 4 Cal1 Cal2 2 8 2 8 4 20C 6 3 a 2010 e 411 20 25 6 b
3. 3 4 Water bath 5 7 9 G0 1 12 13 14 3 2 3 5 Eu ss 20 25C 7 7
4. 2 1 2 3 4 5 MP 1 2 6 Cal1 Cal2
5. NE SR 2 2 1 1 TP 2 Ru bpy TP 3 2 MP SA MP 0 SA P 4
6. 1 000 ppm 0 1 E 1 1 2 Anti TP 2 8 2 1 2 Anti TP 15
7. 2D Cal1 Cal2 20 25C Cal1 Cal2 2010 e 411 2 8 C 1 5 6000 e60 8000 e
8. M Electrochemiluminescence Detection for Development of Immunoassays and DNA Probe Assays for Clin Chem 1991 37 9 p 1 534 1 539 105 0014 2 6 1 0120 600 152 COBAS is a trademark of Roche Roche 0 7277385 001 A
9. v gt 4 1 EDTA 4 Cal1 Cal2 HBs 25 5 HIV HIV 1 HIV 2 HCV 5 2 8 2 20 C 6 5 20 25 C
10. 15 25C Exp 24 Exp 5 5 Anti TP MP V 1 R1 2 R2 1 Cal1 2 Cal2 gt Cal1 Cal2 Cal1 Cal2 100 1X6 5 mL 1X9 mL 1X9 mL 2X 2X 5 6X380 mL M 5 1X2L 2X2L 5 1 Blackburn G F et al Clinical Diagnostics 2 105 0014 2 6 1 0120 600 152 0 mL 0 mL 2
11. 3 5 2 3 4 1 A CLIA 110 i 55 0 55 0 55 55 55 55 110 1009 55 55 100 55 55 100 110 110 2 B PA 110 2 51 1 3 55 0 0 55 55 51 1 58 110 93 51 55 100 55 55 96 106
12. 3500 14 3486 7 99 8 4579 0 4577 3 99 93 8079 14 8063 10 99 88 3 FTA ABS 4 5 1 236 100 MA 236 9 227 9 0 100 4 EIA 1 HAV HBV HCV HIV CMV EBV HSV
13. coObas 2015 3 1 22700AMX00631000 TP ECLIA 1 TP TP 2 2 IL TP Ru bpy TP 2 SA MP RR lt SA Anti TP MP B F
14. 1 2 1 1 6 TP 7 1 5 3 6000
15. B F SA MP Ru bpy TP Ru bpy Cal1 Cal2 1 1 EN a TP OC a 1 2 411 1 gE
16. 8000 e e601 1 1 Anti TP MP 1 2 Cal1 Cal2 Cal1 Cal2 1 0 mL 15 Cal1 Cal2
17. 1 1 L Cal 1 1 1 L Cal 1 CO1 1 1 Cal1 Cal2 1 1 Cal1 0 2XCal2 R CaD
18. 2 KN 3 10 L 175L 1 3 2 75L TP COI 0 6 1 TP TP E COI 1 5 10 2 TP E TP COI 10 4 37 9 2 MP 40 L 37 9
19. 1 000 ppm 0 1 7 8 121 20 1 000 ppm 0 1 1 NE 9 Cal1 Cal2 HIV HBV HCV 0 10 2 3 2H 1 2
20. M M M PC CC M Anti TP a b c 2 8
21. COD OT CIR A ON 1 COD 2 RN CS SS COI 1 0 a M 2 a 3 1 Sg a eS 1 2 Se 2 COI lt 1 0 b 2 1 COI 1 0
22. H Lp ck Ko
23. 1 0 5 g dL TP 66 mg dL MA 2 000 mg dL 2 R2 15 2 2 TI TP 2 10 g dL IgG 32 g L IgM 10 g L lgA 2 8 g dL 15 Ru bpy TP 1 Cal1 3 1 500 IU mL 2 Cal2 lt gt 4 60 ng mL 15 1 5 mg 0 Ro 8 CE 0 2 5 16 In vitro 98 2 4 16 3 DOS 2 EE
24. 1 1 24 3 L Ca 5 Anti TP 24 1
25. 6000 e601 8000 e 20 25 1 2 15 25 3 4 M 5 3 6000 e601 8000 e 2 5 1 Anti TP 2010 2010 2010 M M
26. SA MP Ru bpy TP I 1 1 2 Cal1 Cal2 2 TP 3
27. 110 3 57 gt 50 1 2 51 RE 0 6 6 50 7 57 2 1 COI 1 03 0 990 924 100 1 101 101 0 0 100 2 124 124 0 0 100 470 470 0 0 100 229 227 2 0 100 924 922 2 0 100 3 FTA ABS 8079 99 88 3
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