PDFファイル - 医薬品医療機器総合機構
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1. 2 1 1 1 _ 2 HCV HCV 3 HCV 6 1 9 32. 2 F C 20 4mg d 23 7mg dL 490mg d L 1 8 4 0 2 0 1 1
3. 2 0 2 HCV 3 ee 3 6 4 CV 1 0 C O 1 1 10 0 4 HCV 5 HCV HCV
4. A 1 CV 7 ALP 5 25 1 0 0 1
5. 5 HCV 1 01 000ppm 29 1 2 1 2 0 1 1 M 4 2 2 gt 1 0 2 gt 1 0 HCV 2 gt 1 0 2 1 0 2 gt 1 0 2 1 0 9 9
6. 1 2 50 L HCV c 2 5 HCV c 3 3 c HCV NS 5 2 3 5 0L ALP IgG 3 HCV NN HCV 1 5mL 1 HCV 1 5mLX1 4 100mLxX6 50mLx6 AMP PD 2 5 1000mLx1 6 300mLxX4 80mLx4
7. HCX06T 2013 6 6 2010 5 5 20700AMZ00226000 II C HI HEV C HCV HCV RNA 6 1 2 HCV HCV HCV HCV C HCV RNA
8. 2 HCV 1 5 2 5 NE EN G1200 1 0 07 3 4 1 0 1 5 2 5 5 1 5 2 5
9. 2 2 3 4 6 7 9 10 11 12 2 3 4d 5 2 NM gt HH CV a 8 HCV
10. 1 1 5 2 AMPPD 3 2 spiroadamantane 4 methoxy 4 3 phosphoryloxy pheny 1 2 dioxetane disodium salt 3 2 4 4 3 1 2 2 1 C HCV C HCV HCV 2 HCV HCV lt 2 gt SN HCV c 25 HCV c33c HCV NS5 HCV HCV 2 0 7 18 0L
11. 3 4 HCV HB s HI V HCV 5 HCV HB s HCV H I V o 7 SIC _ RI E 8
12. 1 2 C O I 0 2 1 1 egative Low Titer PHV105 Mixed Titer JIID Seroconv PHV906 Seroconv PHV907 4 4 FF 3 FF Pe 1 ia re 1 C O I No 01 No 01 INo 01 No fo No 01 C O I 1 01 1 511 1 820 1 221 1 01 C 0 NE 2 ou 2 26 leo 2 is 2 oi 2 RN 3 lo2 1 sl relrlsl 04 3 45 3 oil C O I 1 0 41 02 1 4 1401 4 98 91 4 71 4 02 C O I 1 0 5 0 5 19 5 1000 5 11 6 5 0 8 5 0 6 01 6 25 6 92 5 6 143 6 r5 7 0 09111 7 L333 7 26 0
13. 101 0065 3 5 2 Tel 0120 03 6527 http www orthoclinical com ja 2 62 5
14. HCV RNA 2 6 5 527 1 sljooo 521 19 521 61 4 3 0 3 3 3 43 3 0o11 1 HCV 4 0 4 4 4 75 4 021 6 6 0 6 6 43 6 15 HCV 7 0 7 7 20 2 7 26 5 lo 3 2 9 0 0 0 3 rlo 1
15. 5 41 2 4 3 0 3 4 0 5 sl n 6 0 7 0 8 0 C HCV C C C HCV HCV 3 2 3 C O I AMP PD 1 C 0 1 4 8 2 4 CLE
16. FICV 250 HCV 20L 37 10 HCV HCV IgG 2 50 37 10 200 L
17. 1 0 4 1 0 0 0 pp mm 0 0 3 1 HCV
18. a 2 4 0 2 4 0 5 7 5 7 2 4 5 7 81 100 81 8 1 3 P A HCV 3 3 9 P A 1 n 339 r 0 8 4 5 y 7 7506x 47 45 COI x PA y II HCV 2 100 0 hn HH 8 9 O 8 HH o O 6 GDOOQ OO O OO OO WW WP QO OOO Oo O OO O TO OOO QO oP Wo TD 7 r 0 845 7506x 47 45 LH oo 12 14 10
19. 2 5 2 8 0 208 11 8 0 8 2 0 8 63 0 C HCV 5 0 HCV 1 0 0 0 0 HCV 919011T1OIH011T1O1 5721 5 1 02 H1 13 H 63 7 2 01 12 29 12 63 2 HCV 10000 C OI 10 75 COI 10 9925 MMICA NM 50 5 50 5 1 0 41 01 1 4 21 4 488 47 9925 a BE a Rl BE bg 0 47 99 25 6 0 6 90 3 HCV RNA 7 0 7 100 0 HCV RNA HCV RNA 8 0 8 80 5 9 01 9 100 0 28 3 33 11 0 28 0 03 0 44 20 100 0 2 2 Negative Low Titer PHV105 Mixed Titer JIID Seroconv PHV906 Seroconv PHV907 31 0 31 9969 99 69 No Zh No 4 No 6 No iD No 1 ol 1 55 1 80 8 il 24 1 oi
20. 1 A chemiluminescent enzyme immunoassay 1 CO REL 2 0 G1200 GR Mo 0 2 1 1 6 9 8 3 9 8 3 9 9 2 3 1603 1606 8 6 1612 1698 9 9 3 1686 1698 2 8 1 4
21. 16 18 In2 1 5 6 9 C O HCV RNA 2 PA 1 PCR HCV RNA HCV 1 25 3 C O 20 22 n 339 I 1 2 4 HCV RNA 3 1 6 316 C O 4 3 0 1 9 5 3 HCV RNA T 1 2 COI 100 0 n 4 50 0 n 15 10 0 n 130 1 0 n 167 GOsnrmD OO oo ooo HCV RMA HCV RM 2 HCV RNA C O 1 1 1 HIV HBV HCV 2 3 4d pH10 F
22. 60 2 1200 19 243 250 1994 3 1200 HBs HBs HCV gt 2000 F II HBsAgj II HBsAb HCV 17 1161 1166 1994 I 4 Nishizono et al Rapid and sensitive chemiluminescent enzyme immunoassay for measuring tumor markers Clinical Chemistry 37 1639 1644 1991 5 24 27 42 2012 101 0065 3 5 2 Tel 0120 03 6527 URL http www orthoclinical com ja TEL 0120 292 832 FAX 03 5695 9234
23. 9 9 9 9 N o 670008 TII HCV 4 2 xX2 HCV 674006 TII HCV 1 4 X 3 HCV 219973 100mLX6 292600 50mLX6 219942 1000mLX1 219935 300mL X4 292617 8 0mL X4 1 A B 11 52
24. 37 C 5 47 7nm AMPPD HCV HCV HCV 1 1 2 3 4 5 6 HCV EDTA
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