アーキテクト®・HBsAg QT
Contents
1. HBs S CO 125 kL 1 75pL 22. 30
3. HBsAg QT HBsAg QT 1 2 SDS
4. 5 lt gt ARCHITECT HBsAg QT ARCHITECT HBsAg QT 24 1 ARCHITECT HBsAg QT ARCHITECT HBsAg QT
5. HBs
6. 0 1
7. 500 999 25 pL ARCHITECT HBsAg QT 475 pL MM 20 20 pL ARCHITECT HBsAg QT HBsAg QT _ 480 gL 500
8. 2 8 2 8 30 30
9. HBs HBs HBV 3 10 HBs HBs HBs 5 1 5 3 5 HBsAg QT 3 1 1
10. HAMA Human Anti Mouse Antibodies HAMA 2
11. 4 3 _ 3 gt HBsAgQL 1 2 2 1
12. Westgard Levey Jennings 6 lt HBsAg QT gt 4PLC 4 Parameter Logistic Curve fit Y weighted lt HBsAg QT gt 1
13. 1 Primus FJ Kelley EA Hansen HJ et al Sandwich Type Immunoassay of Carcinoembryonic Antigen in Patients Receiving Murine Monoclonal Antibodies for Diagnosis and Therapy Clin Chem 1988 34 261 4 Schroff RW Foon KA Beatty SM et al Human Anti Murine Immunoglobulin Responses in Patients Receiving Monoclonal Antibody Therapy Cancer Res 1985 45 879 8S Hunt CM McGill JM Allen MI et al Clinical relevance of hepatitis B viral mutations Hepatology 2000 31 S 1037 44 Locarnini SA Hepatitis B virus surface antigen and polymerase gene Variants potential virological and clinical significance Hepatology 1998 27 1 294 7 Zuckerman AJ Effect of hepatitis B virus mutants on efficacy of vaccination Lancet 2000 353 1382 4 Carman WF Trautwein C Van Deursen FJ et al Hepatitis B virus envelope variation after transplantation with and without hepatitis B immune globulin prophylaxis Hepatology 1996 24 3 489 93 Grethe S Monazahian M Bohme I et al Characterization of unusual escape variants of hepatitis B virus isolated from a hepatitis B surface antigen negative subject Virology 1998 72 9 7692 6 Nainan OV Stevens CE Taylor PE et al Hepatitis B virus HBV antibody resistant mutants among mothers and
14. lt HBsAg QT gt 1 2 3 3 338 pL 1 ARCHITECT HBsAg QT 15 3
15. A OT TE Sr 0 05 IU mL RS i 2 HBsAg QT gt 2 S CO 1 00 1 1 2 1 2 50 HBs
16. 0 250 1U mL 1
17. 5 HBs Negative Low Titer 105 Mixed Titer 204 Seroconv 929 National Standard No data No IU mL data No IOU mL data No data No 1U mL data 1 0 1 0 3 0 17 1 gt 3 8 gt 250 1 0 1 16 20 8 0 2 0 8 0 57 2 0 5 0 46 2 0 2 8 10 82 3 0 3 0 3 0 21 3 0 8 0 38 3 0 3 4 5 29 4 0 4 0 3 0 19 4 gt 3 8 gt 250 4 0 01 4 2 2 74 5 0 5 0 3 0 19 5 2 1 31 5 0 04 5 1 1 41 6 0 6 0 6 0 45 6 0 5 0 34 6 0 13 6 0 5 0 68 0 7 0 1 0 09 7 NEG 0 7 0 22 7 0 25 0 37 C 8 0 8 0 2 0 17 8 0 3 0 14 8 0 61 8 0 125 0 18 9 0 9 0 2 0 11 9 NEG 0 9 1 8 10 0 0 0 3 2 0 gt 3 8 gt 250 11 0 11 NEG 0 11 4 gt 250 12 0 0 3 0 2 2 0 1 0 09 13 0 13 0 6 0 12 3 0 4 0 28 14 0 14
18. 2 HBsAg QT gt 3 000 mg dL 12 g dL lt 20 mg dL lt 500 mg dL 23 23 0 4 v v 30 28 lt HBsAg QT gt 3 000 mg dL 21 0 4 v v 28
19. IRS a CLIA B 1 EIA EDTA ACD CPDA 1 CP2D CPD HBV
20. HBsAg QT HBs 1 50pL 1 75 pL 10
21. 3 4 2 1 1 ARCHTTECT i CD ROM HBsAg QT HBsAg QT 2
22. 5 6
23. MES ProClin 300 2 8 14 14 NO 20C MES ProClin 300 NN EN2 a a HBsAg QT 23 HBs 4 a a 23
24. HBs ProClin 300 U mL 1 0 5 2 250 ARCHITECT HBsAg OT ARCHITECT HBsAg Controls 6C36 10 8 mL Xx 3 ProClin 300 HBs ad ay ProClin 300 HBs IU mL 1U mL 0 00 0 004 1 0 25 0 16 0 34 2 175 00 113 75 236 25 Acid Blue No 9 Red D amp C No 33 lt HBsAg QT gt ARCHTTECT HBsAg QT ARCHITECT HBsAg Confirmatory V 1 Calibrators 9C94 01 4mL Xx 2 1 ProCli
25. ja 2015 6 6 2013 12 5 HBsAg 21100AMY00212000 6C36 47 0273 R13 B B6C3BJ HBsAg QT B HBV O HBc HBV DNA 1 EIA
26. RLU 1 2 RLU S CO 10 2 6 1 F5 F4 F4
27. 2 HBs 4 6 6429 HBsAg QT HBV 99 87 6001 6009 95 99 74 99 94 99 52 418 420 95 98 29 99 94 5 HBsAg QT HBs 30 HBV HBs
28. 12 g dL 21 20 mg dL 19 500 mg dL 22 3 ARCHITECT TBA 1 2 lt HBsAg QT gt ARCHITECT HBsAg QT ARCHITECT HBsAg Calibrators 3M61 01 4 mL Xx 2
29. 2 3
30. HBsAg QT HBs HIV 1 HIV 1 RNA HIV 1 HIV 2 HCV HBs 1 HBs HIV 1 HIV 1RNA HIV 1 HIV 2 HCV 1 HBs HBs HIV 1 HIV 1RNA HIV 1 HIV 2 HCV HBs HBs HIV 1 HIV 1RNA HIV 1 HIV 2 HCV HBs
31. RLU S CO 6 5 2 0 HBsAg QT gt HBs HBs 250 IU mL gt 250 00 IU mL
32. P333 P313 TE F3624P364 OSHA Standard on Bloodborne Pathogens 2 P501 HBsAg QT 14 17 2
33. 10 000 RCF 5 10 HBsAg QT HBs MES ProClin 300 HBs
34. 426 418 98 12 HBs 4 4 HBsAg QT HBs HBsAg 0T a 3 5043 8 0 16 1 12 50 500 3 0 60 3 100 00 HBV 333 7 2 10 6 85 71 b HBs 343 343C 100 00 343 100 00 B 10 10 100 00 10 100 00 B 50 50 10000 50 100 00 HBV 7 100 5 5 00 5 100 00 6379 426 6 68 418 98 12 a HBsAg QT 2 RLU HBsAg QT RLU S CO 1 00 HBs 1
35. 2 8C 2 8 2 30 18 18 18 HBsAg QT QO OP 6C36 27 100 6 6mLX1 5 9 mL Xx 1 6C36 36 500 27 0 mL Xx 1 26 3 mLX 1 6C36 32 500 X 4 27 0 mL Xx 4 gt 26 3 mL Xx 4 HBsAg QT O QO 9C94 25 50 6 6 mL x 1 5 9 mLx 1 1 2 4mLx 1 2 2 4 mLx 1 6E23 975mLX4 6C55 975mLX4
36. 30 10 HBsAg QT 3 5 1 HBs 6 3 24 1 2 HBs 14 HBs 6 HBs HBsAg QT HBs HBs Gly Arg145 HBs 145 GLY ARG HBs 13 7 HBs HBsAg QT HBV HBs B B HBV 6379 426 HBsAg QT HBs
37. 2 8 2 8 2 8C G3 HIV HBV HCV 1 000 ppm 1 2 1 121 C 20
38. lt HBsAg QT gt 0 05 IU mL 0 05 IU mL 2 2 1 HBs 3 lt HBsAg QT gt 2 S CO 1 00
39. ProClin 300 a HBs 1 EE i HBsAg QT 6 ProClin 300 8 ot RN IO 24 2 ProClin 300 2 8C 20
40. 1 2 1 RLU Qc Cal 3 3 F5 F4 F4
41. 50 2 S CO 1 00 S CO 2 H 1 00 1 00 0 1 00 0 1 00 1 00 0 1 00 0 20000 1 00 1 00 50 1 00 lt 50 EN FTF NV i O1 a Gr ol 500 Hf O1 a IV IMV et 20000 IV IV IIV IV IIV FT 100 HBs HBV HBs
42. l 2537 7 0 28 4 0 16 1 25 00 1 2506 16 0 64 4 0 16 0 0 00 5043 23 0 46 8 0 16 1 12 50 500 3 0 60 3 0 60 3 100 00 l o 0 50 0 000 0 0 00 0 000 HBV 8 333 8 2 40 7 2 10 6 85 71 b a HBsAg QT 2 RLU HBsAg QT RLU HBs 1 50 HBs b CMV 10 EBV 10 HSV 10 HAV 10 HCV 10 HIV 1 10 HBV 10 10 10 10 10 10 10 10 10 10 163 10 3 HBsAg QT
43. 1 2 3 4
44. 0 05 IU mL HBs z2 0 15 0 29 ng mL HBs 343 B 10 B 50 HBV 100 503 503 408 81 11 3 3 HBsAg QT HBs a 343 343 5 100 00 343 100 00 B 10 10 10000 10 100 00 B 50 50 100 00 50 100 00 HBV C 100 5d 5 00 5 100 00 503 408 81 11 408 100 00 a b 1 c 25 25 25 25 d 2
45. 4 ARCHITECT HBsAg QT 2 SD CV 11 12 1 1 HBsAg QT 3 D UmL SD CV SD CV SD CV 1 80 0 23 0011 46 0016 67 0018 7 7 2 80 4 68 0 191 4 1 0 290 6 2 0 339 7 2 3 80 23 76 1 205 5 1 2 179 9 2 2 268 9 5 4 80 96 61 4 617 48 7 587 7 9 8913 92 5 80 182 07 9 448 5 2 14 352 7 9 21 705 11 9 1 180 0 23 0 018 7 8 0 020 8 8 0 022 9 7 2 180 177 36 11 889 6 7 12 969 7 3 16 126 9 1 a b 2 HBV 5043 3 2 0 46 23 5043 0 16 8 504
46. 2 1 200 gL 5 20000 500 25pL ARCHITECT HBsAg QT 975 pL F2 6 1
47. 50 HBs b CMV 10 EBV 10 HSV 10 HAV 10 HCV 10 HIV 1 10 HBV 10 10 10 10 10 10 10 10 10 10 10 163 c 1 d 25 25 25 25 8 0 05 250 IU mL 9 HBs WHO International Standard gg 80 549 10 HBsAg QT
48. 2 3 RLU RLU S CO RLU 1 RLU 0 0075 X 2 RLU 1 RLU S CO RLU RLU 1 2 RLU 2 RLU 1 RLU 100 2 RLU 1 RLU lt gt
49. 6C36 40 ProClin 300 3 HBs 1 1 2 3 HBs 2 1 2 1 1 2 2
50. 0 2 0 27 4 gt 3 8 gt 250 15 0 15 0 2 0 23 5 0 4 0 28 16 0 6 1 2 0 77 17 0 7 gt 3 8 3 85 18 0 8 4 3 53 19 0 9 0 4 0 2 20 0 8 0 46 2 2 0 56 22 2 1 14 23 gt 3 8 3 53 24 gt 3 8 gt 250 25 gt 3 8 gt 250 1 P26 HIV HBV HCV P272 5 5 F280 RE ti P302 P352
51. Organization 2004 17 Clinical and Laboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI Document M29 A3 Wayne PA Clinical and Laboratory Standards Institute 2005 ARCHITECT 5 468 646 5 565 570 5 543 524 5 669 819 5 545 739 5 783 699 270 2214 278 TEL 0120 031441 270 2214 278 TEL 047 385 2211 ABBOTT JAPAN CO LTD 2015 CE Abbott
52. 3 8 1 HBs HBs 500 3 HBs 50 HBV 333 7 7 6 2 HBsAg QT 3
53. Ag Conf F5 1 6 500 2 25 pL ARCHITECT HBsAg QT 475 pL 1 2 20 2 20 20 pL ARCHITECT HBsAg QT 480 pL 500 242 kL 1 500
54. infants with chronic HBV infection In Rizzetto M Purcell RH Gerin JL et al eds Viral Hepatitis and Liver Disease Minerva Medica Torino 1997 132 134 Jongerius JM Wester M Cuypers HTM et al New hepatitis B virus mutant form in a blood donor that is undetectable in several hepatitis B surface antigen screening assays Transfusion 1998 38 56 9 10 Bock CT Tillmann HL Torresi J et al Selection of hepatitis B virus polymerase mutants with enhanced replication by lamivudine treatment after liver transplantation Gastroenterology 2002 122 264 73 SAS Institute Inc The MIXED Procedure In SAS Technical Report P 229 SAS STAT Software Changes and Enhancements Release 6 07 Cary NC SAS Institute Inc 1992 289 366 mm 12 Box GBP Hunter WG Hunter JS Statistics for Experimenters An Introduction to Design Data Analysis and Model Building New York John Wiley amp Sons Inc 1978 510 39 571 83 13 Oon C Lim G Ye Z et al Molecular Epidemiology of Hepatitis B Virus Vaccine Variants in Singapore Vaccine 1995 13 8 699 702 14 US Department of Labor Occupational Safety and Health Administration 29 CFR Part 1910 1030 Bloodborne pathogens 15 US Department of Health and Human Services Biosafety in Microbiological and Biomedical Laboratories Stn ed Washington DC US Government Printing Office December 2009 16 World Health Organization Laboratory Biosafety Manual 3rd ed Geneva World Health
55. n 300 2 HBs ad ProClin 300 2 HBs QU mL 1 0 2 5 ARCHITECT HBsAg QT ARCHITECT HBsAg Confirmatory V 1 Controls 9094 10 8 mL Xx 2 ProClin 300 HBs gy ProClin 300 HBs Y GU mL S CO S CO 0 00 0 52 0 00 0 90 0 25 3 22 1 61 4 83 50 Acid Blue No 9 lt gt ARCHITECT i CD ROM ARCHITECT HBsAg QT ARCHITECT HBsAg Manual Diluent
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