PDFファイル - 医薬品医療機器総合機構
Contents
1. 9 ADVIA Centaur ADVIA Centaur XP ADVIA Centaur XPT ADVIA Centaur CP 100pL 100pL 37 29 37C 29 200pL 100pL 37C 18 37C 18 BF2. HBe 1
3. o 22300AMX00410000 2015 1 3 2013 4 2 B e HBe
4. CLSI Clinical and Laboratory Standards Institute 24 24 5 1 2 8
5. Be 2 2 1 2 2 3 9
6. 1 1 500Xg 10 2 3 CLSI EP7 A22 20 ADVIA Centaur ADVIA Centaur CP 40 mg dL
7. 1 20 Index HBe ROC ADVIA Centaur XP XPT ADVIA Centaur CP HBV 392 98 21 HBe 214 212 2 ADVIA Centaur ADVIA Centaur XP XPT ADVIA Centaur CP
8. 2 8 HBe HBe 1 2 8C 8 2 8C 8 2 25 C 1
9. HBV 7 HBV 1 6 6 8 HBV HBV 90 95 HBV 5 10 HBV 90 B 3 HBV HBV HBV 5 7 8 HHBe HBV
10. 98 21 385 392 95 96 36 99 28 0 98 gt 1 20 Index 11 7 18 0 80 1 19 Index 0 4 4 lt 0 80 Index 0 385 385 11 396 407 2 1 1 3 ADVIA Centaur ADVIA Centaur CP ADVIA Centaur HBe 253 ADVIA Centaur CP ADVIA Centaur CP ADVIA Centaur 100 253 253 95 98 55 100 253 253 0 0 100 2 HBV 216
11. 1 HBe 6 0 mL HBe HBe lt 0 1 11 5 mL HB6e HBe lt 0 1 6 0 mL HBe lt 0 1 HBe 2 0 mL 2 0 mL HBe lt 0 1 HBe 2 1500 mL 0 5 0 1N
12. 5 EDTA Be HBV HBe B HBV
13. HBe 1 HBe 2 3 2
14. ADVIA Centaur HBe ADVIA Centaur CP ID ADVIA Centaur ADVIA Centaur CP PHM935B 135 135 0 RP 016 60 60 0 214 1 1 EIA 100 9 109 2 5 7 0 98 98 102 112 214 95 65 198 207 2 2 ECLIA 103 7 110 3 4 7 1 96 97 107 107 214 96 14 199 207 CLSI EP5 A21 ADVIA Centaur XP XPT 4 3 1 2 20
15. 1 Good Laboratory Practice GLP 314 2 FDA HBs HCV HIV1 2 HBs BPL UV 2 8
16. 1 50 gL 4 5 6 7 8 7 1 100 pL 200pL 2 8
17. 2 8C 7 2 8C 7 2 8 5 10 20 5 4 10 000xg 2 2 8C 7
18. 2 2 1 2 2 3 9 1 50 gL 4 5 6 7 8
19. 1 HBe 300 HBe HBe 5 2 2H 3 2 2H 3
20. 20 mg dL 500 mg dL 400 mg dL 500 mg dL 6 0 gdL 11 g dL 9 gldL 8 g dL EDTA 500 ng mL HBe ADVIA Centaur ADVIA Centaur CP 5 ANA HSV 1 C HCV HIV 1 HAMA A HAV Total
21. 3 1 000ppm 1 1 2 121 C 20 1 1 4 2 2 1 4 2 8 C El
22. B 4 25 2 2 1 6 HBe 1 50 E gt 5000 1500 mL ADVIA Centaur XP XPT 1000 300 mL ADVIA Centaur CP E HBe 10 0mLx2 10 0mlL x2 1 2X2500mL ADVIA Centaur XP XPT CP 2x1500mL ADVIA Centaur XP XPT CP 03150214 1 E 1 03852677 112219 00497043 03221634 03773025 01137199 112351 11 1 13 14 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 Clinical and Labor
23. 1500 mL 0 25N ADVIA Centaur CP 300mL HBe B HBe HBe HBe HBe HBe ADVIA Centaur ADVIA Centaur 1 EDTA
24. 2 625 HBV 2 HBe 3 2 ADVIA Centaur 1 207 201 HBV 1 401 385 5 11
25. 1 300pL 300gL Ww BF B bound F free HBe RLUs 1 0 Index 0 80 1 20 Imdex 1 1 HBe Index 0 80 Index HBe 0 80 Index 1 20 Index 2
26. 213 211 2 0 100 00 211 211 95 98 27 100 00 0 93 1 20 Index 211 1 212 0 80 1 19 Index 2 0 2 lt 0 80 Imdex 0 2 2 213 3 216 100 00 212 212 95 98 28 100 00 0 93 1 20 Index 212 0 212 0 80 1 19 Index 2 0 2 lt 0 80 Index 0 2 2 214 2 216 ADVIA Centaur ADVIA Centaur CP ADVIA Centaur HBe 252 ADVIA Centaur CP ADVIA Centaur CP ADVIA Centaur 97 22 385 396 95
27. HBe lt 0 1 1 lt 0 1 1 2 ADVIA Centaur CP 1 3 42 21 ADVIA Centaur CP 42 2 21 ADVIA Centaur CP 42
28. EBV VZV CMV IgG CMV IgM IgG HBs 13 12 10 10 143 140 oOo mm 0 Nn Wo oOo 0 oO O00 NM 0 mm 0 ON To oR OO 0 0 0 NN 0 0 Co a 1 2 42 ADVIA Centaur HBe HBe
29. Index SD CV SD CV SD CV SD CV 2 76 0 05 2 0 0 04 1 4 0 09 3 1 0 11 4 0 1 0 31 002 0 04 0 02 0 05 2 1 18 0 04 3 2 0 04 3 6 0 02 1 6 0 06 5 1 3 1 36 0 04 2 9 0 02 1 8 0 05 3 9 0 07 5 2 4 2 09 0 05 2 6 0 07 3 2 0 01 0 3 0 09 4 1 ADVIA Centaur CP 2 1 2 20 2 mdex SD CV SD CV SD CV 2 58 0 06 2 3 0 1 3 5 0 11 42 1 1 0 03 001 002 0 02 2 2 77 0 08 2 8 0 1 3 8 0 13 4 7 PEI Paul Ehrlich Institute HBe 3 ADVIA Centaur CP 1 Index 1 00 PEI PEI International Unit TU
30. 1 22 95 08 98 61 1 20 Index 8 11 19 0 80 1 19 Index 0 5 5 lt 0 80 Index 0 385 385 8 401 409 100 252 252 95 98 55 100 252 0 252 0 100 5 ADVIA Centaur XP XPT HBV HBe