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PDFファイル - 医薬品医療機器総合機構
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1. 3 1 HIV HBV HCV 1 000ppm 1 2 1 121C 20 2 PITVKA I
2. de nt PIVKA I DE UA EE OD 20 1 10mAU mL 0 mAU mL 2 2 3 80 120 3 100mAU mL 10 000mAU mL 5 CV 10 4 I 1 126 PIVKA II ECLIA
3. 1 20 100 7 1mL 2 ECLIA II 3 1 PITVKA I 2 3 1 1mL 4 5 6 1 1 mL 6 BF 7 3 1 100 2
4. 53 0 6 300 L Q2PIVKA I i 1 28mAU mL 2 40mAU mL PIVKA II PITVKA AFP
5. PIVKA I I 1 1 2 3 4 M 1 K PIVKA II 2 K PIVKA I
6. BF 0 Iw v 005w v 4 1 PIVKA T 2 10C 21 2 2 10C 21 3 2 10C 21 4 2 10C 21 5 6 2 10C 21 BN 12 12 Mn BF PIVKA II MONO 1 100 PIVKA T MONO 6
7. 22500AMX01779000 877449 PIVKA I PIVKA I 2015 5 3 2014 2 2 Es P VA 7 ONO zee zzz7P VKA 7 ONO 1 i 3 1 4 ri 6 ES 9
8. 1 7 1 PIVKA II 2 10C 1 PIVKA I s 9 2 10 3 8 9 PIVKA I
9. 20 L 2 3 20 gL ECLIA 4 PIVKA IL 25 5 30 2 C 9 6 7 BF 350 8 97 8 QO 200 L 30 2 C 9 G2 RM G3 BF 350 gL
10. r 0999 y 1 084x 54 730 2 126 A CLEIA r 0 995 y 1 060x 71 579 55 PIVKA II ECLIA r 1000 y 0991x 7 706 1 HIV HBV HCV 3 2 1 2 PIVKA T
11. 0 II Ru 0 ECLIA Elec immunoassay PIVKA I ro chemiluminescence PIVKA I PIVKA I PIVKA I 2 PIVKA II PIVKA I
12. 1 gt BE es 1 DORNER I NNEE SIRE SE ENE EGA RE ERI SS 1 DLiebman H A et al New Engl J Med 310 1427 1984 11 539 1985 5 55 1986 14 759 1987 28 1073 1987 65 941 1988 73 2656 1996 The Medical amp Test Journal 791 6 2001 00120 921 207 FAX03 3864 5644 hhc 0120 419 497 FAX03 3811 4946 1 10 6 03 3865 4311 4 6 10 055727 5
13. i SOC AI Aa NM en RA US PITVKA I 3 mL 1 1 i PIVKA II 1000mAU BL mL 9 ws a 15mL Hepes 1 PIVKA I OmAU mL 10mAU mL 100 1mL mAU mL 1 000mAU 1 6 ZmL 10 000mAU mL 6 50000mAU mL NN yy 2 a BF 1 Na 2 7 PIVKA I
14. 3 PIVKA II 4 489 0mg dL 5 19 1mg dL 20 0mg dL 6 1440 3 4 ECLIA II 6
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