PDFファイル
Contents
1. 1 3 5 12. HCV 1 150 gL 1 20 gL 10
3. 2 8 2 8 2 30 9 12 18 HCV QO QO 6C37 27 100 6 6mLX 1
4. 30
5. 1 OO 2 3 4
6. SDS 2
7. IgG IgM
8. 5 6 3
9. 5
10. TRIS 10 000 RCF 10
11. Triton X 405 H319 P264 P280 P305 P351 P338 P337 P313 Triton X 405 H318 H412 P280 P273 P305 P351 P338
12. 3 70 LL 1 20 kL 3 3
13. 2 8 7 15 30 3 3 2 20 mg dL 500 mg dL 3 000 mg dL 12 g dL 23 23 0 4 v y 25 25 3 ARCHITECT
14. 2 8 3 HIV HBV HCV 1 000 ppm 1 2 1 121C 20 0 1
15. P310 P501 EUHO032 P501 3
16. OSHA Standard on Bloodborne Pathogens 2 47 HIV 1 RNA E HCV HBs HIV 1 HIV 1 HIV 2 HBs HIV 1 RNA HIV 1 HCV HIV HIV 2 E
17. ja 2015 5 3 Pp 2014 5 2 Anti HCV 21100AMY00254000 6C37 47 0229 R11 C B6C37J HCV C HCV HCV RNA
18. 5 468 646 5 543 524 5 545 739 5 565 570 5 669 819 5 783 699 270 2214 278 TEL 0120 031441 270 2214 278 TEL 047 385 2211 ABBOTT JAPAN CO LTD 2015 CE Abbott
19. 8 942 2 59 E HCV 2 15 1 16 1 500 99 88 HCV 5 6 HCV 65 3 2 3 1 b 3 000 1
20. 117 a NE HCV 50 50 100 00 50 100 00 HCV HCV RNA 42 42 100 00 42 100 00 HCV b 25 8 32 00 8 100 00 117 100 85 47 100 100 00 a 2 b 5 5 4 1 10 2 3 10 624 99 45 99 71 99 70 1994 2000 99 89 5 HCV E 99 60 10 361 10 403 95 E 99 20 496 500 99 10
21. 1 1 3 5 1 1 2 1 1 x 0 074 2 S CO 1 00 S CO lt 1 00 1 2
22. EDTA OR Gb 15 6 50 PD 50 1 a 48 2000 mL 1 0 2000 mL 10 000 RCF 10
23. 2 mm 4 3 4 l SD CV 2 1 1 S CO SD CV a 5 SD CV SD CV 1 180 7 39 0 351 4 7 0 395 5 3 0 447 6 0 2 180 3 92 0 138 3 5 0 169 4 3 0 209 5 3 3 180 1 50 0 056 3 7 0 067 4 4 0 095 6 4 4 180 0 08 0 005 5 6 0 007 8 4 0011 13 4 80 3 27 0 127 3 9 0 147 4 5 0 166 5 a b 2 28 HCV 1
24. 1 6 1 3 S CO 1 S CO F X 0 074 s co lt 100 100 2 2
25. 2 1 2 HCV E HCV
26. 5 9mLX 1 10 0 mL Xx 1 6C37 37 500 27 0 mL Xx 1 26 3 mL X 1 50 9 mL Xx 1 6C37 32 500 x 4 27 0 mL Xx 4 26 3 mL x 4 50 9 mL Xx 4 6E23 975 mLx 4 6C55 975 mL X 4 LL U S Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Guidance for Industry Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells Tissues and Cellular and Tissue Based Products HCT Ps November 2004 http www fda gov BiologicsBloodVaccines GuidanceComplianceRegulatoryInformation Guidances Tissue ucm073972 htm Accessed July 01 2013 2 SAS Imstitute
27. TBA 1 2 ARCHITECT HCV ARCHITECT Anti HCV Calibrator 1 HCV Acid Yellow No 23 Acid Blue No 9 ARCHITECT HCV ARCHTTECT Anti HCV Controls 6C37 01 4mL 1 6C37 10 8mLX2 HCV S CO 0 60
28. 2 8 C 2 8 30 30 2 8 2 8
29. 6 es HCV MES MES
30. C HCV C ea ease l 2 8 7 i a sp B OO 2 8C a 20 6 25 25 1 7 PT l 2 8C 20 L
31. Sr 1 71 5 13 Acid Blue No 9 3 1 1 1 9 5 5 1 2 100 kL 3 300 kL 400 500 nm 4
32. 4 1 3 1 24
33. 95 96 77 20 HCV 20 1 3 1 HCV 3 5 6 1 HCV 16 HCV 6 7 4 No 1 Negative Low Titer PHV105 Mixed Titer JIID Seroconv PHV906 Seroconv PHV907 No data COT No data COD No data COI No d
34. Inc The MIXED Procedure In SAS Technical Report P 229 SAS STAT Software Changes and Enhancements Release 6 0Z Cary NC SAS Institute Inc 1992 289 366 3 Box GEP Hunter WG Hunter JS Statistics for experimenters an introduction to design data analysis and model building New York NY John Wiley amp Sons Inc 1978 510 539 571 583 4 US Department of Labor Occupational Safety and Health Administration 29 CFR Part 1910 1030 Bloodborne pathogens 5 US Department of Health and Human Services Biosafety in Microbiological and Biomedical Laboratories 5th ed Washington DC US Government Printing Office December 2009 6 World Health Organization Laboratory Biosafety Manual 3rd ed Geneva World Health Organization 2004 7 Clinical and Laboratory Standards Institute CLSI Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI Document M29 A3 Wayne PA CLSI 2005 C HCr43 c100 3 Chiron Corporation Ortho Diagnostic Systems and Chiron Corporation ARCHITECT
35. 4 0 47 12 0 40 0 2 508 11 0 44 11 0 44 0 3434 37GO8 36GO5 28 7778 8 942 62 0 69 59 0 66 28 47 46 1 500 100 6 67 99 6 60 88 88 89 HCV 65 3 4 62 3 4 62 3 100 00 C a 2 b 500 L c CMV 5 EBV 5 HAV 5 HBs 5 HIV 1 5 5 5 5 HBc 5 HTLV I 5 10 5 3 HCV 50 HCV 25 100 3 3 HCV RNA 42 HCV 117
36. 9 0 0 13 10 0 14 10 14 47 11 0 17 11 3 38 11 12 94 12 0 10 12 2 56 12 14 81 3 0 09 13 3 51 13 13 06 4 0 13 14 2 92 14 12 90 15 0 14 a 15 3 78 15 14 68 6 0 28 16 12 97 7 0 16 3 17 14 97 8 0 15 Fs 18 15 46 19 0 15 19 15 86 20 16 39 1 HIV HBV HCV
37. ata COTD No data COT 1 0 16 1 7 06 ke 1 14 35 1 7 73 1 0 16 2 0 11 2 5 63 a 2 15 49 2 7 89 4 0 15 3 0 09 3 2 42 5 3 13 66 3 9 34 3 0 15 4 0 13 gt 4 6 43 4 16 17 4 10 02 4 0 92 S 0 16 5 2 60 F 14 92 5 10 79 5 4 35 6 0 22 6 3 03 6 13 66 6 11 17 6 5 64 7 0 12 7 2 00 7 14 68 7 11 75 i 7 12 78 8 0 15 5 8 4 29 8 13 31 9 0 19 9 1 58 ko 9 12 98 0 0 13 ee 10 0 13 10 13 54 1 0 16 11 3 44 5 11 325 1 2 0 10 Ft 12 2 79 12 14 43 3 0 10 13 3 29 13 13 9 4 0 13 14 2 84 14 1273 5 0 14 5 15 3 87 15 14 65 6 0 28 16 13 0 7 0 16 17 14 46 8 0 15 i 18 14 9 9 0 15 st 19 15 40 20 16 0 5 No 2 Negative Low Titer PHV105 Mixed Titer JIID Seroconv PHV906 Seroconv PHV907 No data COI No data COr No data COr No data COI No data CO 1 0 16 1 6 63 1 13 70 1 7 45 1 0 17 2 0 11 2 5 59 3 15 10 2 8 06 2 0 15 a 3 0 10 3 2 43 0 3 14 13 3 9 50 3 15 4 0 14 4 6 49 4 15 44 4 9 62 4 0 91 5 0 16 5 2 78 5 14 12 10 60 5 4 40 6 0 21 a 6 2 86 6 13 55 6 11 26 6 5 57 7 0 13 MM 2 05 7 14 53 7 11 55 6 13 02 8 0 15 8 4 21 8 13 46 9 0 19 ter 9 5 9 13 0
Download Pdf Manuals
Related Search