PDFファイル - 医薬品医療機器総合機構
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1. ADVIA Centaur XP XPT CV CV CV 0 20 4 3 8 5 9 8 0 28 2 6 3 7 5 1 0 33 1 9 4 2 5 1 0 50 2 1 4 4 5 3 0 97 1 5 2 1 3 4 1 81 1 6 7 7 7 9 3 95 1 6 8 5 8 6 7 53 2 1 7 6 7 9 65 94 1 5 1 2 7 4 ADVIA Centaur CP CV CV CV 0 21 3 07 2 15 5 64 0 3 2 28 2 01 4 28 0 36 1 88 1 61 4 53 0 54 2 39 1 71 3 81 1 09 1 97 1 26 3 49 2 08 1 55 1 29 2 63 4 61 1 22 0 93 2 14 8 63 1 15 1 37 2 14 77 82 2 81 1 85 4 64 LoB 0 03 nglmL 75 ng mL LoB 95 k LES BRAHMS 2 8 C 242. 8 25 5 8 2 8C 48 20 5 2
3. VY TI 6 EEEO BRAHMS 1 1 2 0 mL 2 20 30 C 15 20 3
4. 10 500mg dL 1000mgldL HJE 40mg dL JE 40mg dL 3 5gIdL 500nglmL 400mgldL 3 ADVIA Centaur 0 3 ng mL 8 0 25 30 0 03 30 0 03 144 0 00 a CGRP 30 0 03 CGRP 30 0 00 30 0 20 900 000 0 00 11 200 0 00 130 000 0 00 20 000 0 00 40 000 0 00 1 180 000 0 00 200
5. BRAHMS 5 2 2H 3 2 2H 3 2 8C 2 8C
6. 42 5 2 BRAHMS 1 100 WL OS dead volume 2
7. 22300AMX01247000 m Wo m 1 BRAHMS 5 0 mL PCT MB
8. A 1 2001 19 6 3 ES 30 50 80 215 000 A 1 1 5 CDC 1979 2000 300 COR 5 ik A FE i 4E TH 750 000 A 0 E 500 3 22 000 167
9. ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP 100pL 15 15 45pL 45pL 50pL 37 5 75 20 100 pL 100 pL SOL 37 C 18 37C 20 7 Vv BF 1 M 300 pL 300 pL NV B F B bound ER F free PCT RLUs m 1 PCT 0 1 ngimL 8 ADVIA Centaur 456 96 88 190 EDTA 82 PCT 0 PCT PCTY
10. BRAHMS N Edmann s PCT 1 HIV HBV HCV CDOH lt 2 pH13 CT 1 000 ppm 1
11. 2 E a oe 10
12. 75 ng mL ACS 1 Dilution point 275ng mL Dilution factor 20 ADVIA Centaur CP 25 2 2
13. BEAT Emory University School 6 PCT 116 C 0 1ng mL 2 93 A PCT 2ng mL 500ng ml Assicot PCT PCT
14. 3 2 1 121 20 m 1 1 2 8 2 2 8 3 4 25 C1 12 2 12 3 1 6
15. PCT 1 PCT PCT 1 0 02 75 ng mL 2 1 High Low High Low Low 1000 2 2 20 3 2 3 CV 10 3 1 ADVIA Centaur XP XPT PCT ED 0 05 80 ng mL 202
16. 8 20 42 5 1 2 25 1 ACS 1 2 8T 28 PCT 5 6 2 2 mn 60 LoD 95 PCT CLSI EP17 A 2 PCT 5 6 2 2 mn 60 LoD 0 04 ng mL 20 0 05 ng mL PCT 0 01 0 20 ng mL 5 3 45 3 3 n 135 PCT
17. PCT 10 0 mL 5 0 mL PCT PCT BRAHMS 2 0 mL PCT PCT 2 1500 mL A 0 5 0 1N 1500 mL 0 25N ADVIA Centaur CP 300 mL PCT BRAHMS m
18. BRAHMS 100 10378883 1 1 BIER 1 gt 5000 1500 ml 03852677 ADVIA Centaur XPIXPT 112219 1000 300 ml 00497043 ADVIA Centaur CP 1 2X2500 mL ADVIA Centaur XP XPTICP H 03773025 21500 mL ADVIA Centaur XP XPTICP H 01137199 112351 ACS 1 07293184 2X25 mL 110312 BRAHMS 10378884 T 10 11 12 1 2x2mL 2 2x2 mL Clinical and Laboratory Standards Institute formerly NCCLS Proce dures for the Handling and Processing of Blood Specimens Approved 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 Angus DC Linde Zwirble WT Lidicker
19. PCT 2000ng mL PCT 75 ng mL 3 2O 25 C CT 20 25C 20 25 1C 2 CP 3 0 6 ADVIA Centaur a FH m
20. EDTA 0 98 i13 0 24 ng mL AAR 0 999 n 50 1 01 0 03 0 983 n 50 20 9811 0 14 0 999m 50 CLSI EP5 A2 1 3 2 20 n 120 ACS 1 1 BRAHMS 300
21. ADVIA Centaur ADVIA Centaur PCT ADVIA Centaur PCT 0 95 0 00 ng mL r 0 99 PCT 0 06 73 8 ngmL 107 ADVIA Centaur PCT ELFA ADVIA Centaur PCT 0 72 f r 0 989 0 078 ng mL PCT 0 04 51 26 ngmL 120 ADVIA Centaur PCT ECLIA Oil ADVIA Centaur PCT 0 94 U r 0 978 ADVIA Centaur CP 0 027 ng mL PCT 0 05 80 ngmL 202 ADVIA Centaur CP ADVIA Centaur CP PCT ADVIA Centaur CP PCT 0 98 0 02 ng mL r 0 99 5 2 EDTA
22. PCT PCT PCT WU BF RLUs PCT M ADVIA Centaur ADVIA Centaur 2015421 Hl 3 2013 4 2 MIEXI EDTA HUMR ZEH EE CLSI Clinical and Laboratory Standards Institute
23. gt 2 ng mL 2 8 1 ng mL 0 5 ng mL o PCT 0 5 2 0ng mL RLUs
24. 2004 NCCLS Document EP5 A2 Clinical and Laboratory Standards Institute formerly NCCLS Proto cols for Determination of Limits of Detection and Limits of Quantitation Approved Guideline Wayne PA Clinical and Laboratory Standards Institute 2004 CLSI document EP17 A m 03 3493 8400 1 11 1 ADVIA Centaur ACS 180 Siemens 10378883M1 02 ADVIA Centaur 10629885 EN ReV E CP 10629983 Rev C
25. 0 0 00 3 500 000 0 00 lM ule 1 2 60 ADVIA Centaur 1 lt 0 1 ACS 1 0 1 BRAHMS amp ri 1 2 ADVIA Cent
26. J Clermont G Carcillo J Pinsky MR Epidemiology of severe sepsis in the United States Anal ysis of incidence outcome and associated costs of care Crit Care Med 2001 29 7 1303 1310 Brun Buisson C The epidemiology of the systemic inflammatory response Intensive Care Med 2000 26 1 S64 74 Martin GS Mannino DM Eaton S Moss M The epidemiology of sepsis in the United States from 1979 through 2000 N Engl J Med 2003 Apr 17 348 16 1546 54 Yu DT Black E Sands KE et al Severe sepsis variation in resource and therapeutic modality use among academic centers Crit Care Med 2003 7 R24 R34 Snider RH Nylen ES Becker KL Procalcitonin and its component perptides in systemic inflammation immunochemical characteriza tion J Investig Med 1997 45 9 552 560 BRAHMS PCT Sensitive KRYPTOR assay instruction manual ver 2 0us Harbarth S Holeckova K Froidevaux C et al Diagnostic value of procalcitonin interleukin 6 and interleukin 8 in critically ill patients admitted with suspected sepsis Am J Respir Crit Care Med 2001 164 396 402 Assicot M Gendrel D Carsin H et al High serum procalcitonin con centrations in patients with sepsis and infection Lancet 1993 Feb 27 341 8844 515 8 Clinical and Laboratory Standards Institute formerly NCCLS Evalu ation of Precision Performance of Quantitative Measurement Methods Approved Guideline Second Edition Wayne PA Clinical and Laboratory Standards Institute
27. aur CP 1 3 4 5 ACS 1 60 H 35 2 REH 35 VAR A T OPE
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