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PDFファイル - 医薬品医療機器総合機構

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2. ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP 25pL 50pL 37 4 66 50pL 250pL 37C
3. EC S MA 1 000 ppm 1
4. ACS CA15 3 TH 2 8 C 28 ACS 1 2 8C 28 APW 1 2 8C 14 CA15 3 ADVIA Centaur XP XPT
5. 28 1 25 dead Volume 2
6. B C HIV Good Laboratory Prac tce GLP 678 2 2 8 2 8C 3
7. Dilution factor 2 2 2
8. 7 8 7 450U mL ACS 1 Dilution point 450U mL Dilution factor 10 20 ACS 1
9. CLS1 Clinical and Laboratory Standards Institute 2 8 8 2 8C 48 20 1
10. 5 3 5 450 U mL 1 CA15 3 20 40 U mL B low CA15 3 160 350 U mL B high B high B low 10 30 2 3 CA15 3 20 3 CA15 3
11. 1 7 7 7 2 7 2 1 T
12. 1000xg 15 20 lt ADVIA Centaur 5 20 mg dL 99 6 20 mgdL 100 0 3000 mg dL 101 6 500 mg dL 104 3 12 g dL 100 0 CLSI EP
13. 21100AMY00010000 BR 2015 1 6 2013 4 5 15 3 ACS CA15 3 1 ACS CA15 3 II 2 5 mL CA15 3
14. 78 4 125 8 107 5 11 89 31 36 UmL CA15 3 6 460 29 UmL CA15 3 ACS 1808 87 5 128 9 98 69 29 94 7 ADVIA Centaur XP XPT 4 6 12 4 6 n 72 UImL CV CV CV 30 5 5 2 5 5 7 6 88 2 1 9 2 1 2 8 136 7 1 7 1 5 2 3 350 3 1 4 3 8 4 1 ADVIA Centaur CP 4 1 2 20 10 2 n 160 U ml CV CV CV 31 45 4 0 6 9 8 0 42 69 3 8 5 8 6 9 99 6 1 8 4 0 4 4 126 9 2 4 2 3 3 3 8 450 U ml 3 5 UmL
15. CA15 3 CA15 3 CA15 3 CA15 3 CA15 3 CA15 3
16. 2 121 96 2 1 2 8 2 4 25 1 8 2 1 ACS CA15 3II 250 116735 5 C03896216 ACS CA15 3II 50 116734 1 024199379 lt 7 5000 1500 mL 03852677 ADVIA CentauwXP XPT 112219 1000 300 mL
17. CA15 3 12 5 ml CA15 3 BR 2 1500 mL 0 5 0 1N 1500 mL 0 25N ADVIA Centaur CP 300mL CA15 3 CA15 3 B27 29 MUC 1 CA15 3 ADVIA Centaur ADVIA Centaur 1
18. CA15 3T G 1 ACS 1 te CA15 3 HI APW 1 0 FDA B HBsAg C HCV HIV 1 2
19. 28 Use Beyond 7 Verify Stability 28 28 3 07 2 7 ADVIA Centaur CP 28 974 2 7
20. MRI CT ACS 180 2 ULN 38 6 U mL ULN 38 6 U mL ULN 60 39 79 48 28 69 93 87 96 98 94 100 PPV 60 39 79 80 52 96 NPV 93 87 96 91 85 95 95 2 58 62 53 97 PPV23 73 NPV84 94 38 42 86 100 PPV42 100 NPV86 9
21. ADVIA Centaur BR ACS 180 ACS 180 BR ADVIA Centaur BR 1 00 ACS 180 BR 0 94 UjmL 0 99 ADVIA Centaur CP 1 CA15 3 4 31 448 9 UmL 598 ADVIA Centaur BR ADVIA Centaur CP ADVIA Centaur CP BR ADVIA Centaur CP BR 0 986 ADVIA Centaur BR 0 87 U mL rv 0 993 2 CA15 3 4 42 342 6 UmL 143 ADVIA Centaur CP BR ACS 180 BR ADVIA Centaur CP BR 1 03 ACS 180 BR 3 31 U ml r 0 995 5 6 ADVIA Centaur XP XPT CA15 3 326 04 416 17 UmL 10 ACS 1 2 4 8 16 81 3 109 0 99 6 ADVIA Centaur CP CA15 3 288 7 407 5 UImL 5 ACS 1 2 4 8 16
22. 5X 105 2 10X 105 8 10X 95 6 10X 93 3 2X 101 7 10X 96 4 2X 99 5 10X 96 6 10X 104 9 CEA 30 ng7mL 103 8 CA125 300 U ml 105 9 CA19 9 300 U ml 103 6 1 2 ADVIA Centaur CA15 3I G 0 33 0 1 CA15 3 TI 0 24N 1 lt 0 1 ADVIA Centaur CP ACS 1 0 1 APW
23. 00497043 ADVIA Centaur CP CA15 3 TH G 112776 2 06354201 CA15 3 06288756 2x10 0 ml 116746 APW 1 03395373 2X25 ml 1 2x2500 mL ADVIA Centaur XP XPT CP 03773025 2X1500 mL ADVIA Centaur XP XPT CP 01137199 112351 ACS 1 2x25 mL 07293184 110312 1X50 mL 09348792 672177 1 Clinical and Laboratory Standards Institute formerly NCCLS Proce dures for the Handling and Processing 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 Clinical and Laboratory Standards Institute formerly NCCLS Inter ference Testing in Clinical Chemistry Approved Guideline Second Edition Wayne PA Clinical and Laboratory Standards Institute 2005 NCCLS document EP7 A2 Clinical and Laboratory Standards Institute formerly NCCLS How to Define and Determine Reference Intervals in the Clinical Labora
24. ACS 1809 18 50 314 ULN 99 38 6 UmL CA15 3 CA15 3 gt 38 6 UmL ULN 314 1 97 81 129 3 29 7 43 26 47 43 45 47 50 56 20 60 34 18 30 13 49 2 37 11 25 24 24 8 48 10 50 6 20 15 ADVIA Centaur CP 4 3 CA15 3
25. 1 0 4N 1 2 ADVIA Centaur CP 1 3 4 CA15 3 II 5 ACS 1 CA15 3T CA15 3T G ADVIA Centaur XP XPT
26. 3 C V 10 1 TI T II 1 NED 162 ACS 180 18 24 CA15 3 3 ACS 180 CA15 3 ACS 180 PPV NPV 162 25 X
27. BR RLUs 2SD CA15 3 95 9 CA15 3 1 HIV HBV HCV pH lt 2 DH13
28. 2 2 15 PPV NPV PPV NPV 10 49 95 73 94 15 60 93 81 91 20 68 90 86 88 25 74 87 89 85 30 79 84 91 81 2 97 ACS 180 6 3 20 20
29. 7 5 WV 37 9 66 BF 1 Ww 300 L 300pL WW B F B bound F free CA15 3 RLUs i 8 CA15 3 U ml 198 2SD 27UJmL ACS 180 103 ACS 180 CA15 3 0 96 1 045 7 6
30. 7 A23 ADVIA Centaur CA15 3 5 1 445 4UJmL CA15 3 5 10 CA15 3 10X 96 3 4 100 9 10X 100 1 1X 96 2 10X 96 9 10X 100 2 10X 101 8 10 95 9 5 10 104 2 10X 99 9 10X 98 0
31. ULN 79 2 7 79 CA15 3 20 33 10 lt 20 12 24 73 58 85 71 53 85 PPV 77 61 88 NPV 67 49 81 95 PPV NPV PPV NPV 57 PPV NPV PPV NPV 25 45 4 88 8 35 57 3 83 1 45 67 1 76 4 55 75 3 68 4 65 82 2 58 8 75 88 2 46 9 4 ADVIA Centaur XP XPT CA15 3 6 54 448 94 UmL 225 ADVIA Centaur
32. tory Approved Guideline Second Edition Wayne PA Clinical and Laboratory Standards Institute 2000 NCCLS Document C28 A2 Bombardieri E Pizzichetta M Veronesi P et al CA 15 3 determina tion in patients with breast cancer clinical utility for the detection of distant metastases EurJ Cancer 1993 29A 1 144 6 Centers for Disease Control 1988 Update Universal precautions for prevention of transmission of human immunodeficiency virus hep atitis B virus and other bloodborne pathogens in healthcare settings MMWR 37 377 82 387 8 Clinical and Laboratory Standards Institute formerly NCCLS Protec tion of Laboratory Workers From Occupationally Acquired Infections Approved Guideline Third Edition Wayne PA Clinical and Laboratory Standards Institute 2005 NCCLS Document M29 A3 Federal Occupational Safety and Health Administration Bloodborne Pathogens Standard 29 CFR 1910 1030 03 3493 8400 x 1 11 1 ADVIA Centaur ACS 180 Siemens 10333349M1_02 ADVIA Centaur 10630988 EN Rev L CP 10629928 Rev D

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