PDFファイル - 医薬品医療機器総合機構
Contents
1. 1 HBe 2 2 12. 2 1 2 2 3 9 1 50 gL 4 5 6 7 8
3. 1 HBe 0 2 2 2
4. ADVIA Centaur XP XPT HBe Signal 4 error Signal 4 error ACS 10 Dilution point 1000 Index Dilution factor 100 1000 ACS 10 HBe
5. 3 B F B bound F free Index 1 0 Index 1 1 HBe Index 0 80 Index HBe 0 80 Index 10 0 Index 2 3 2 1 00 I
6. 22200AMX00292000 2015 1 3 2013 4 2 B e HBe HBe HBe
7. 5 2 EDTA HBe HBV HBe B HBV
8. HBe 5 2 2H 3 2 2H 3 1 Good Laboratory Practice GLP 121314 2 FDA HBs HCV HIV1 2
9. 1500Xg 10 2 4 10 CLSI EP7 A22 ADVIA Centaur ADVIA Centaur CP 60mg dL 40mg dL 3000mgdL 500mgdL 3 5g dL 12 0g dI
10. A HAV 10 10 0 C HCV 10 10 0 10 10 0 EBV 1gM 10 10 0 HSV IgM 10 10 0 IgM 10 10 0 HIV1 10 10 0 VZV IgM 10 10 0 lgM 10 10 0 CMV IgM 10 10 0 10 10 0 10 10 0 HAMA 10 10 0 130 180 0 x i 1 2 60
11. 2 8C a 2 8 C a 3 1 Clinical and ILaboratory Standards Institute formerly NCCLS roce NN gt gt dures for the Handling and Proc
12. HBV 67 HBV 1 6 6 8 HBV HBV 90 95 HBV 5 10 HBV 90 B 3 HBV HBV HBV 7 8 HBe HBV
13. 30 ADVIA Centaur CP 28 6 HBe
14. 2 2 3 9 1 50 pL 4 5 6 7 8 7 1 100 pL dead volume 2
15. HBe ADVIA Centaur ADVIA Centaur 1 HBe 14 0 mL HBe HBe lt 0 1 6 0 mL HBe
16. ADVIA Centaur HBe HBe HBe lt 0 1 1 lt 0 1 3 lt 0 5 ACS 10 1 2 ADVIA Centaur CP 1 3 60 30 ADVIA Centaur CP 28 2
17. CLSI Clinical and Laboratory Standards Institute 24 24 10 24 24 2 8C 2 8 7
18. 1 1 EIA 100 0 100 0 100 100 100 100 200 100 200 200 2 BCLIA 5 100 0 100 0 100 100 100 100 200 100 200 200 CLSI EP5 A2 1 ADVIA Centaur XP XPT 4 1 2 20 2 3 n 120 Imdex SD CV SD CV SD CV SD CV 0 07 0 09 NA 0 03 NA 0 02 NA 0 10 NA 7 56 0 22 2 8 0 15 2 0 0 09 1 2 0 28 3 7 1 2 49 0 14 5 7 0 10 4 0 0 06 2 3 0 18 74 2 4 51 0 21 48 0 12 2 6 0 11 24 0 27 5 9 3 14 50 0 71 4 9 0 38 2 6 0 35 24 0 88 6 1 4 83 11 280 34 0 63 0 8 145 17 3 21 3 9 NA ADVIA Centaur CP 3 2 20 4 20 2
19. HBe lt 0 1 6 0 mL lt 0 1 HBe 2 0mL HBe 2 0mL lt 0 1 HBe 2 1500 mL 0 5 0 1N 1500 mL 0 25N ADVIA Centaur CP 300mL HBe 1 EDTA
20. n 160 Index SD CV SD CV SD CV 0 24 0 06 NA 0 03 NA 0 07 NA 6 34 0 21 3 3 0 15 2 3 0 25 4 0 1 0 22 0 06 NA 0 03 NA 0 06 NA 2 2 34 0 08 3 5 0 03 1 1 0 09 3 7 3 97 71 2 12 2 2 0 67 0 7 2 22 2 3 NA PEI Paul Ehrlich Institute HBe 2 ADVIA Centaur CP 1 Index 1 00 PEI PEI IU 0 10 IU mL HBe B 6
21. HBe HBe HBe HBV B 69 10 1 0 05 Index 2 0 05 1000 Index 1 2 1 00 Index 1 00 Index 3 3 2
22. 98 52 100 0 247 0 247 100 0 Oi ADVIA Centaur XP XPT HBV Be ID RP 009 11 11 0 RP 016 57 57 0 ADVIA Centaur CP ADVIA Centaur ADVIA Centaur CP HBV ADVIA Centaur CP ADVIA Centaur ADVIA Centaur HBe ADVIA Centaur CP ID ADVIA Centaur ADVIA Centaur CP RP 009 11 11 0 RP 016 57 57 0 200
23. 621 HBV HBe 1 ADVIA Centaur XP XPT 201 HBV 202 99 5 99 5 401 403 95 98 22 99 94 2 201 200 99 5 201 100 202 201 99 5 202 100 403 401 403 ADVIA Centaur ADVIA Centaur CP
24. ADVIA Centaur HBe 248 ADVIA Centaur CP 98 79 245 248 95 96 51 99 759 248 245 3 98 79 2 ADVIA Centaur XP XPT HBV 218 206 HBe 206 0 100 206 206 95 98 23 100 00 _ gt 1 0 Index 206 0 206 lt 1 0 Index 0 12 12 206 12 218 ADVIA Centaur ADVIA Centaur CP ADVIA Centaur HBe 247 ADVIA Centaur CP 100 0 247 247 95
25. B B 1 2 HIV HBV HCV pH lt 2 pH13 HBe HBe 1
26. 100mg dL HBe ADVIA Centaur ADVIA Centaur CP qureus 1000 CFU mL qureus 10 000 CFUImL aeruginosa 1000 CFUImL aeruginosa 10 000 CFU mL coli 1000 CFUImL coli 10 000 CFUImL aureus 1000 CFU mL aureus 10 000 CFUImL aeruginosa 1000 CFUImL aeruginosa 10 000 CFU mL coli 1000 CFU mL coli 10 000 CFU mt EBV 1 dmL es EBV 1 ng ml a CMV 1 gm CMV 1 ng mL a VZV 1 pgiml VZV 1 ngmL 9 Rubella 1 gmL Rubella 1 ngmL EBV 1 pw gimLl EBV 1 ng mL CMV 1 rgmL CMV 1 ng mL VZV 1 pgiml VZV 1 ngmL Rubella 1 gmL Rubella 1 ng ml hd My ys hm hy Mt HBe ADVIA Centaur
27. 03852677 mm 112219 Pathogens Standard 29 CFR 1910 1030 ADVIA Centaur XP XPT 1000 300 mt 00497043 ADVIA Centaur CP SE 1 03 3493 8400 2x2500 mL ADVIA Centaur XP XPTCP 03773025 2x1500 mL ADVIA Centaur XP XPT CP 01137199 112351 3 03333963 1 11 1 1x50 mL HBe 01512437 ADVIA Centaur ACS 180 Siemens 2 10 0 mL 2X10 0 ml ACS 10 2x5 mL 117227 10291295M1 02 ADVIA Centaur 10629869 Rev L CP 10629970 Rev D
28. 2 8 C 3 10 3 20 10 3 10 000Xg 2 2 8 7
29. 3 10 ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP 100 pL 37C 6 37 4 0 100 pL 250 pL 37 18 37 17 0 WW BF 1 4 100 pL 37 17 0 BF 1 37 18 300pL 300 L WW
30. Heterophilic antibodies a problem for all immunoassays Clin Chem 1988 34 27 33 ee 2 5 Clinical and Laboratory Standards Institute formerly NCCLS How 1 hy I NA NR gi to Define and Determine Reference Intervals in the Clinical Laboratory MO Approved Guideline Second Edition Wayne PA Clinical and Laboratory Nt Standards Institute 2000 NCCLS Document C28 A2 na ii 6 Gitlin N Hepatitis B diagnosis prevention and treatment Clinical Chemistry 1997 43 8 B 1500 1506 7 Mahoney FJ Update on Diagnosis Management and Prevention of Hepatitis B Virus Infection Clinical Microbiology Reviews 1999 12 o MMS 1 8 Juszczyk CHinical course and conseduences of Hepatitis B infec NR tion Vaccine 2000 18 S23 S25 Peer UM 2 9 Vivek R Treatment of hepatitis B Clin Cornerstone 2001 3 6 24 36 0 3 2 425 10 Koff RS Hepatitis B today clinical diagnostic overview The Pediatric infectious disease
31. essing of Blood Specimens Approved Guide NT line Third Edition Wayne PA Clinical and Laboratory Standards Institute 2004 NCCLS Document H18 A3 2 Clinical and Laboratory Standards Institute formerly NCCLS ner HBe 2 8C 8 ference Testing in Clinical Chemistry Approved Guideline Second Edition HBe 2 8C 8 Wayne PA Clinical and Laboratory Standards Institute 2005 1 2 25C 1 NCCLS document EP7 A2 a 3 Clinical and Laboratory Standards Institute formerly NCCLS 3 2 6 100 Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Oper 3 ang Characteristic ROC Plots Appr7oved Guideline Wayne PA Clinical a and Laboratory Standards Institute 1995 NCCLS Document GP10 A 1 000ppm 1 2 1 121 20 4 Boscato LM Stuart MC
32. journal 1993 May 12 5 428 32 2 11 Clinical and Laboratory Standards Institute formerly NCCLS Evalu 1 ation of Precision Performance of Quantitative Measurement Methods 2 Approved Guideline Second Edition Wayne PA Clinical and Laboratory 2 1 6 Standards Institute 2004 NCCLS Document EP5 A2 12 Centers for Disease Control Update Universal precautions for prevention of transmission of human immunodeficiency Virus hep HBe 01512127 atitis B virus and other bloodborne pathogens in healthcare 50 ON ON A en Ss me 13 Clinical and Laboratory Standards Institute formerly NCCLS Protec gt 1 tion of Laboratory Workers From Occupationally Acgujred Infections lt gt Approved Guideline Third Edition Wayne PA Clinical and Laboratory Standards Institute 2005 NCCLS Document M29 A3 Ns 14 Federal Occupational Safety and Health Administration Bloodborne 5000 1500 ml
33. ndex 3 2 1 00 Index 10 0 Imdex 4 ROC 3 ADVIA Centaur CP 201 HBV 202 2 HBe 206 206 100 ADVIA Centaur ADVIA Centaur ADVIA Centaur CP
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