PDFファイル - 医薬品医療機器総合機構
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1. 2013 4 4 21600AMY00004000 2010 8 3 B e al Centaur HBs Centaur HBs B HBV Ea ELE Mit 7 AEF RY 7A lt 0 1 HBc HBV DNA ERRHIER 2 5 mt RE HBR 0 l HBs HBs 12. CLSI EP7 A2 ADVIA Centaur 10 500mg dL El if 1000mg dL SH 40mg dL SH 40mg dL 128 dL 38 dL IgG 6g L IgG 3 ADVIA Centaur ee 14 14 0 SLE 11 11 0 10 10 0 ANA 9 8 18 10 9 1 2 2 0 A HAV 4 4 0 C HCV 2 2 0 6 6 0 VZV 7 7 0
3. 3 2 o E E EE 2 Centaur HBs es 3 Neal
4. HBs ADVIA Centaure ADVIA Centaur 1 EDTA CLSI Clinical and Laboratory Standards Institute
5. 20 10 ena 2 7 7 2 3 3
6. 2 m 2 1 2 1 d 3 6 7 4 5 6 7 Ay TF O bell 100 50xL
7. 2 1 2 2 1 50 3 6 7 4 o 5 7 oe a 6 8
8. dead volume E E 2 SIME RIBLERIAA vy TAO E 7 3 1 lava lt Centaur Bs
9. 1 ES B high Blow DE B high B low 5 25 13 7 2 3 3 ADVIA Centaur 2 211 HBV 483 5058 2
10. Centaur HBs 1 ADVIA Centaur XP 100 483 483 95 CD 99 24 100 00 CL Ku gt 1 00 Index lt 1 00 Index gt 1 00 Index 481 2 483 lt 1 00 Index 0 0 0 481 2 483 ADVIA Centaur ADVIA Centaur CP ADVIA Centaur 152 ADVIA Centaur CP ADVIA Centaur CP 100 152 152 95 CI 97 60 100 CLK ADVIA Centaur CP 152 0 152 100 2 ADVIA Centaur XP HBV ADVIA Centaur 99 94 5259 5262 95 CD 99 83 99 99 CLE BER E MEHE 211 209 2 2 1 1
11. a IBRAHIM O 1 ADVIA Centaur ADVIA Centaur XP ADVIA Centaur CP 100 L 120zL 37 5 37 4 7 105 L 25uL 370 18 NV 37C 16 044 B F 1 y 3004 L 300 nL Nr
12. HAS RSV 21 2 ADVIA Centaur CP 60 H Tt Centaur HBs i 1 Centaur HBs
13. 14 lt 0 10 14 0 2 5 63 15 lt 0 10 15 0 2 6 55 2 8 16 lt 0 10 17 lt 0 10 1 8 lt 0 10 _ 19 0 29 u Good Laboratory Practice GLP Mixed Titer 4204 1011 12 No IU mL data le No IU mL data 2 FDA HBs HCV HIV1 2 0 HBs 2 0 5 12 24 15 0 4 8 35 BPL UV 3 0 8 6 25 iG 16 1 2 24 11 de
14. HBs m 6 ER 7 H H m
15. 1 Centaur HBs 21 0 mL lt 0 1 5 0 mL lt 0 1 24 0 mL HBs HBs HBs HBs lt 0 1 u 1 HBs HBs HBs
16. TAME AN SETH OD HBs ME IEI HBs B B B
17. 24 10 2 8C 2 8 7 H a e IR IR ET 2 8C C7 WERIT KEV 24 SODNE Mie 5 HE 7 lt EP TUAH Besen EG RK E HO 104 pee ad nem LO A ARAS oe 2 8
18. 2 HBV 3 1 00 Index HBs 1 00 E 50 Index HEBs 2 Centaur HBs HBs 50Index HBs HBV Centaur HBs ADVIA Centaur ADVIA Centaur CP J
19. 3 lt 0 5 41 ADVIA Centaur CP 60 H 21 41
20. 1 2 1 6 Centaur HBs 200 03393362 1 1 2 5000 1500 mL 03852677 ADVIA Centaur XP FA 112219 1000 300 mL 00497043 ADVIA Centaur CP FA Centaur HBs 03394660 1 2X2500 mL ADVIA Centaur XP CP 2Xx1500 mL ADVIA Centaur XP CP APW 1 2X25 mL 1 10 11 2X10 0 mL 2x10 0 mL 03773025 01137199 112351 5 go 5 03395373 Zo u 3 03333963 1X50 0 mL Centaur HBs 100
21. 1 0 19 1 03 4 49 2 ee j 7 5 m IAs 7 DH lt 2 pH13 CT 9 0 10 T 3 0 3 5 26 a 4 lt 0 10 4 0 3 4 99 5 lt 0 10 5 0 3 5 53 6 lt 0 10 6 0 6 14 39 7 lt 0 10 7 0 1 1 64 2 8 lt 0 10 8 0 2 4 40 2 8 9 0 11 9 0 2 3 31 on 10 lt 0 10 10 0 3 4 92 11 lt 0 10 11 NEG lt 0 10 12 0 14 12 0 3 5 23 13 lt 0 10 13 0 6 17 53
22. IU mL CUZ 2SD 0 004 0 066 IU mL 0 028 IU mL PRADA EROS DTT L Negative Low Titer 105 HIV HBV HCV No data No IU mL data
23. Index SD CV SD CV SD CV 0 04 0 05 NAS 0 01 NA 0 05 NA 2 95 0 15 5 2 0 10 3 2 0 18 6 1 1 0 07 0 06 NA 0 03 NA 0 07 NA 2 0 81 0 09 11 0 0 07 9 2 0 12 14 3 3 1 32 0 10 7 5 0 08 6 2 0 13 9 7 4 2 42 0 16 6 5 0 09 3 6 0 18 7 4 5 18 14 0 46 2 5 0 27 1 5 0 53 2 9 e NA HBs ADVIA Centaur CP ADVIA Centaur WHO 2nd In ernational Reference Standard 00 588 ADVIA Centaur CP ADVIA Centaur XP 1 0 Index 2SD 0 021 1IU mL 1 0 Index A y RA
24. 3 1 5 6 ADVIA Centaur Centaur HBs Centaur HBs HBs HBs ERA 1 lt 0 1 APW 1 0 4N
25. HBV ADVIA HBs 483 100 TJE PENE ADVIA Centaur Centaur E 1 1 5058 211 10 7 483 ADVIA Centaur 2 EDTA HBV Bir
26. B HBV LH FRR IC HEL CVS UE TEN PRB ESI 5 6 HBV y ER HKA c DIAZ HBV 1 6 6 8 THEIRTE O IETJE TE BERRUET HBV HBV 90 95 HBV 5 10 y IBV HBV 90 B 3 WES HBV HBV 5 6 7 B HBsAg
27. 03393818 Clinical and Laboratory Standards Institute formerly NCCLS Procedures for the Handling and Processing of Blood Specimens Approved Guideline Third Edition Wayne PA Clinical and Laboratory Standards Institute 2004 NCCLS Document H18 A3 Clinical and Laboratory Standards Institute formerly NCCLS Interference Test ing in Clinical Chemistry Approved Guideline Second Edition Wayne PA Clinical and Laboratory Standards Institute 2005 CLSI document EP7 A2 Boscato LM Stuart MC Heterophilic antibodies a problem for all immunoas says Clin Chem 1988 34 27 33 Clinical and Laboratory Standards Institute formerly NCCLS How to Define and Determine Reference Intervals in the Clinical Laboratory Approved Guide line Second Edition Wayne PA Clinical and Laboratory Standards Institute 2000 NCCLS Document C28 A2 Gitlin N Hepatitis B diagnosis prevention and treatment Clinical Chemistry 1997 43 8 B 1500 1506 Mahoney FJ Update on Diagnosis Management and Prevention of Hepatitis B Virus Infection Clinical Microbiology Reviews 1999 12 2 351 366 Juszczyk J Clinical course and consequences of Hepatitis B infection Vaccine 2000 18 S23 S25 Vivek R Treatment of hepatitis B Clin Cornerstone 2001 3 6 24 36 Clinical and Laboratory Standards Institute formerly NCCLS Evaluation of Precision Performance of Quantitative Measurement Methods App
28. ADVIA Centaur CP APW 1 3 2 B F F free 1 HBs Index B bound 1 0 Index Index lt 1 00 1 00 AR 3 mi an HBs
29. 1 125 125 0 2 20 20 0 3 25 25 0 10 10 0 HAMA 9 9 0 10 10 0 IgM 7 7 0 IgG 8 8 0 CMV 10 10 0 EBV 5 5 0 10 10 0 314 312 2 a ANA HBs HBs 1 1 I 2 3 4 HS FE AV ADVIA Centaur CP
30. ADVIA Centaur XP ADVIA Centaur HBs ID PHIM 907 50 50 0 PHM 908 20 20 0 PHM 912 42 42 0 PHIM 915 33 19 4 PHM 916 65 65 PHM 919 19 19 PHM 922 16 21 PHM 926 13 PHM 928 14 PHM 929 18 18 0 BCP 62433 22 19 BCP 62675 19 19 0 BCP 63568 10 14 BCP 62825 29 26 BCP 64121 27 27 0 BCP 63133 36 36 0 BCP 61291 98 108 3 PHM 933 7 7 0 PHM 931 19 19 PHM 932 61 50 l PHM 930 3 0 1 c 4 ADVIA Centaur 4 ADVIA Centaur CP ADVIA Centaur ADVIA Centaur CP ADVIA Centaur amp HBs ADVIA Centaur CP ID ADVIA Centaur ADVIA Centaur CP 1 PHM 908 20 20 0 PHM 912 42 42 0
31. 5058 5050 15 8 6 2 5269 5259 17 10 7 3 HBV 6 1 ADVIA Centaur ADVIA Centaur CP ADVIA Centaur CP ADVIA Centaur 1009 99 90 1008 1009 95 CD 99 45 100 ADVIA Centaur CP 1009 1008 1 gt 99 90 b HBs Invalid 3 HBV 170 ADVIA Centaur HBV
32. E a sie 00s ot m ren 4 SRA O AE 5 2 2 49 84 PA 18 17 3 44 NM A u A A A A 8 03 567 21 12 106 as a FR oz 9 NEG lt 010 22 2 0 45 21 Be Oe AS L AES TES re io gt 38 gt 10 Em 11 24 12 0 1 263 25 gt 3 8 170 96 gt e SA 26 ES Centaur HBs 2 8C 8 Seroconv 928 HBsAg National Standard Centaur HBs 2 8C 8 No dat ee No IU mL data H APW TO 7 Yee L 2 80 14 1 0 15 1 16 267 68 3 2 8C 60 2 T 2 age j 1 2250 1 3 0 64 u 3 4 85 05
33. B HB HB HBV 1 sAg HBV IBsAg B 1 10 HBsAg 3 5 HBsAg HBsAg V 1 HBsAg HBsAg HBV 56 8 am 1 0 1 1000 Index 2
34. 2 EIA 2an as IREKI 1500mL 0 5 0 1N SET E Kerr RER i NEE a ADVIA Centaur CP 300mL B EIA RIED HBs PURO HL E HBV A
35. a 4 0 10 4 2 47 73 nn acm g von EEES SBR DIEU GE THESES EE BO ME 9 AO E 6 03 1200 7 116 98 7 0 25 6 18 1 000ppm 1 2 1 8 0 125 3 06 EAERI 125 DU DAA RYL Y 1210 20 Seroconv 929 No data 1 lt 0 10 2 lt 0 10 3 0 31 u 4 0 39 5 0 83 w 6 2 61 1 7 4 63 1 8 12 65 2 8 9 36 46 2 2 25C 2 1
36. PHIM 919 19 14 1 PHM 926 9 0 PHM 928 9 0 PHM 929 18 18 0 PHM 930 0 0 0 PHM 931 19 19 0 PHM 932 50 50 0 PHM 933 T 7 0 BV6272 108 108 0 BV6286 36 33 l BV6288 14 14 0 BV6291 27 27 0 BV11014 51 51 d 4 ADVIA Centaur CP ADVIA Centaur 4 5 ADVIA Centaur XP CLSI 20 day precision stud y EP5 A2 9 1 2 20 28 n 80 2 Index SD CV SD CV S
37. D CV SD CV 476 009 19 0 09 18 09 20 0 16 3 3 K2 EDTA 0 49 0 05 98 0 04 7 4 02 3 7 0 06 12 8 K2 EDTA 86 0 07 36 0 00 0 0 05 26 0 08 45 K2 EDTA 3 93 01 27 003 0 9 09 22 0 14 36 K2 EDTA 19 13 0 37 20 0 36 1 9 26 14 058 31 0 36 0 04 9 7 0 02 6 6 03 7 0 0 05 13 7 177008 46 0 04 2 1 04 25 0 10 56 3 77 0 08 2 1 0 06 16 06 16 0 11 3 0 16 92 0 30 8 0 20 1 2 24 14 043 2 5 0 38 0 04 114 0 03 8 3 03 86 0 06 16 5 1 97 005 28 006 2 9 05 2 6 09 48 3 92 012 3 1 0 07 17 00 0 0 014 3 5 17 58 0 27 6 02 12 20 11 040 2 3 0 42 0 05 11 2 0 02 3 8 02 54 0 05 13 0 2 08 0 10 47 0 04 18 00 00 010 5 0 3 72 0 10 28 0 07 19 00 00 013 34 19 87 0 39 2 0 0 43 2 2 20 1 0 0 62 3 1 0 56 004 7 2 0 0 2 5 03 55 0 05 94 1 82 0 06 3 2 0 05 2 5 04 21 0 08 46 3 57 0 07 20 0 04 12 06 17 O10 2 9 17 07 0 37 22 0 34 2 0 39 23 0 64 3 7 ADVIA Centaur CP CLSI EP5 A29 1 2 20 2 2
38. roved Guide line Second Edition Wayne PA Clinical and Laboratory Standards Institute 2004 NCCLS Document EPS A2 Centers for Disease Control Update Universal precautions for prevention of transmission of human immunodeficiency virus hepatitis B virus and other bloodborne pathogens in healthcare settings MMWR 1988 37 377 382 387 388 Clinical and Laboratory Standards Institute formerly NCCLS Protection of Laboratory Workers From Occupationally Acquired Infections Approved Guide line Third Edition Wayne PA Clinical and Laboratory Standards Institute 2005 CLSI Document M29 A3 12 Federal Occupational Safety and Health Administration Bloodborne Pathogens Standard 29 CFR 1910 1030 13 03 3493 8400 1 11 1 Di ADVIA Centaur ACS 180 Siemens mA 10309057M1_02 ADVIA Centaur 03418888 Rev N CP 10629974 Rev D
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