PDFファイル - 医薬品医療機器総合機構
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1. ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP 100 kL 100 L 50xL 37 2 75 37 3 0 150 pL 37 5 0 37 6 32. ACS UL 11
3. 1 2 8C 2 4 25 1 18 2 10 3 1 6 Centaur 1 500 02790309 5
4. ACS 11 2 8C 28 1 2 25 1 3 rm 1 000 ppm 1 2 1 121 20
5. 4 4 2 8 24 20 1 1 2200xg 10
6. 10 500 mgdL 1000 mgdL 20 mg dL 20 mg dL 12 gldL 8 gldL 10 ng mL 1gG Centaur XP XPT IgG Centaur CP E 0 3 1 0 ng mL 1 2 4 3 nmolL 6 10 ngjmL 41nmolL 1 10 10
7. ACS 11 Dilution point 2 50 ngmL Cp gL Dilution factor 2 5 10 T 11 10 Dilution factor 1
8. L ADVIA Centaur XP XPT ADVIA Centaur CP 2 150 100 5 60 40 10 30 25 2 2 2
9. 1 2 8C 2 8C
10. 22000AMX00271000 2015 1 6 2013 4 5 Centaur 1
11. ADVIA Centaur 11 1 lt 0 1 1 2 ADVIA Centaur CP 1 3 4 28 28 2 28
12. EDTA Passing Bablok ADVIA Centaur XP XPT 1 0 99 1 0 03 ngIml p gL n 53 EDTA 1 0 96 1 0 02 ngmL pg gL n 31 ADVIA Centaur CP I 0 97 1 0 0 ngmL p gL n 83 EDTA I 1 04 D 0 01 ngmL Cp gL n 55 EDTA 2 3 2
13. 87 7 107 0 99 8 7 ADVIA Centaur XP XPT 6 2 20 20 2 ngmL pgL CV CV 0 08 5 1 5 3 0 18 3 4 4 1 0 64 2 1 2 9 2 94 1 3 2 7 10 7 7 2 9 27 2 1 9 3 0 ADVIA Centaur CP 6 2 20 10 2 ngimL pglL CV CV CV 0 048 6 2 92 7 1 0 12 5 9 2 8 6 1 0 66 3 8 2 0 4 3 0 89 3 7 2 3 4 4 4 22 3 3 839 4 8 36 1 3 3 1 7 3 8 10 50 ng mL pg L 0 006 ngjmL p gL 1 20 RLUs 2SD 1 209
14. 1 3 cTnI CTntl 2 CTnt ADVIA Centaur ADVIA Centaur 1 EDTA CLSI Clinical and Laboratory Standards Institute
15. 3 4 30 1 5 4 2 8C 24 20 30 4 28 1 UL 2 3
16. Ks 8 1 2 ACS UL 3 1 2 0 mL 2 20 30 15 20
17. 2 Centaur 100 02789602 1 1 lt gt 5000 1500 mL 03852677 ADVIA Centaur XP XPT 112219 1000 300 mL 00497043 ADVIA Centaur CP 1 2x2500 mL ADVIA Centaur XP XPT CP 03773025 2x1500 mL ADVIA Centaur XP XPT CP 01137199 112351 11 2X5 mL 05699280 117228 1X10 mL 03479704 111088 1 Clinical and Laboratory Standards Institute formerly NCCLS Proce 2 dures for the Handling gnd Process7ng of Blood Specimens ADD7OVed Guide line Third Edition Wayne PA Clinical and Laboratory Standards Institute 2004 NCCLS Document H18 A3 Boscato LM Stuart MC Heterophilic antibodies a problem for all immunoassays Clin Chem 1988 34 27 33 3 CHinical and Laboratory Standards Institute formerly NCCLS How ro Defin
18. ADVIA Centaur XP XPT 1 0 1 30 9 ngImL gp gL 334 ADVIA Centaur ADVIA Centaur Tnl Ultra ACS 1808 ACS 1 ACS 180 cTnT ADVIA Centaur TnI Ultra 0 8ZACS 180 cTnD 0 02 ngjmI p gL r 0 97 1 0 1 46 0 ng mL pgL 1039 ADVIA Centaur TnI Ultra ACS 1 ADVIA Centaur cTnT ADVIA Centaur TnI Ultra 0 94 ADVIA Centaur cTnD 0 01 ngjmL gL r 0 98 1 0 0 37 4 ng mL pgL 542 ADVIA Centaur TnI Ultra ADVIA Centaur TnI Ultra 1 66 0 005 ngmL gp gL r 0 98 Passing Bablok ADVIA Centaur CP 1 0 00644 4 ngImL rgL 993 ADVIA Centaur CP
19. ADVIA Centaur 0 02 0 06 ngmL ADVIA Centaur ADVIA Centaur CP AMI 3 0 03ngjmL 10 ADVIA Centaur CP 99 CV 10 ESC ACC 1 Q 1
20. CV 10 99 0 04 ng ml pgL 0 02 0 06 ng mL jp gL 5 ADVIA Centaur XP XPT 1 9 55 45 02 ngImL 10 ACS 11 2 5 10 60 118 93 ADVIA Centaur CP 1 4 34 33 57 ngmL 10 ACS 11 2 5 10 75 101 92 6 ADVIA Centaur XP XPT 2 05 27 80ng mL I 6 92 5 105 5 ADVIA Centaur CP 5 15 21 80ng mL 6
21. 53 pgImL 12 pgImL Propanolol 10 ng mL Captotril 5pgimL 10 pgImL 200 ngIml 400 gmL 2 dmL 15 gmL 400 ng mL 40 rdmL 60 gmL 250 ng7mL 50 gmL 600 pgjmL 4r9mL 400 gmL L 40 dmL DOPA 15 pg mL 6 25 pgmL 1 I I II Si ng mL T 1000 ND 1 1000 lt 0 007 1000 ND 1000 lt 0 005
22. ACS I ACS 180 0 1 ndqmL 1 RLUs 1000 ngmL x gL 1I 50 ndmL pgL 4 HAMA 7
23. 1 Centaur IT 10 0 mL CTnI CTnt 16A11 CTnl 1 CTntf 19C7 CTnl 2 15 0 mL 5 0 mL lt 0 1 ACS UL 2 0 mL cTnI 2 0 ml TnI Ultra 2 1500 mL 0 5 0 1N 1500 mL 0 25N ADVIA Centaur CP 300mL
24. 0 006 50 ngImL Cp gL 1 High Low RLU High Low Low 10 1990 2 1 1 0 05 0 20 ng mL 40 2 0 20 25 0 ng mL 30 3 25 0 65 0 ng mL 30 3 3 1 0 05 0 20 ngjmL CV 15 2 0 20 25 0 ng jmL CV 10 3 25 0 65 0 ng mL CV 10 3
25. 1I 0 017 ngmLl pgL 0 007 0 182 ngimL pg L CV 7 NIST SRM 2921 1 2 HIV HBV HCV pH lt 2 pH13
26. 4 1 0 mL 1 0 mL 5 6 7 1 100 pL dead volume 2 50 ngmL pgL
27. ACS 180 Siemens 10317708M1_03 ADVIA Centaur 10629901_EN Rev L CP 10629999 Rev H
28. ADVIA Centaur CP TnI Ultra ADVIA Centaur TnI Ultra ADVIA Centaur CP TnI Ultra 0 99 ADVIA Centaur TnI Ultra 0 04ngjmL gp gL r 0 99 0 00 44 4 ng mL rg 124 ADVIA Centaur CP TnI Ultra ACS 1 ADVIA Centaur CP cTnT ADVIA Centaur CP TnI Ultra 1 02 ADVIA Centaur CP cTnl 0 2 ngimL p gL r 0 99 1 0 00 44 4 ngImL pgL 83 ADVIA Centaur CP TnI Ultra ACS 180 cTnI ADVIA Centaur CP TnI Ultra 1 0WACS 180 cTnD 0 13 ngmL p gL r 0 99 4 ESC ACC European Society of Cardiology American College of Cardi ology 99 99
29. C 1000 lt 0 005 1000 ND 1000 ND CK MB 1000 ND ND CLSI EP7 A2 5 2 2 1 ADVIA Centaur XP XPT 25 25 ngImL pg gL lt 0 006 0 12 0 006 0 354 ngImL pg L 0 008 0 033 ADVIA Centaur CP 24 24 ngImL pg gL lt 0 01 0 13 lt 0 01 0 337 ngImL pg gL 0 01 0 037 1 1 2 28
30. WW BE 1 4 300 pL 300 pL Ww B B bound F free 1I RLUs 1 1 ng mL pg SI 1 0 ngmL 1 0 pg 3 CLSI C28 A23 648 17 91 EDTA 1845 99 0 04 ng7mL rgL 99
31. e Determine ond Utilize Re7erence Intervals in the Clinical Laboratory Approved Guideline Second Edition Wayne PA Clinicaland Laboratory Standards Institute 2000 NCCLS Document C28 A2 4 TheJoint European Society of Cardiology American College of Cardi ology Committee Myocardial infarction redefined a concensus doc ument of theJoint European Society of Cardiology American College of Cardiology commrittee for the redefinition of myocardial infarc tion J Am Coll Cardiol 2000 36 959 69 6 5 CHnical and Laboratory Standards Institute formerly NCCLS nrer 7ference Testing in Clinical Chemistry Approved Guideline Wayne PA Clin ical and Laboratory Standards Institute 2002 CLSI Document EP7 A2 6 Williams EJ Campbell AK A homogeneous assay for biotin based on chemiluminescence energy transfer Anal Biochem 1986 155 249 255 7 Schroff RW Foon KA Beatty SM et al Human anti murine immun0 globulin responses in patients receiving monoclonal antibody ther apy Clin Cnem 1988 34 261 264 03 3493 8400 x 1 11 1 ADVIA Centaur
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