PDFファイル - 医薬品医療機器総合機構
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1. 4 i30 5 6 BR2 10 3uL 10 3 L R3 11L R4 5 4uL C1 3uL R1 28uL C2 4uL 8uL 5 3uL 2 FD 7uL 72. DNA Fab TnT 6 2 C2 0 82 mL T Fab TnT 7 FD 1 4 mL T LBA Liquid phase Binding Assay T DNA Fab TnT T Fab TnT T 2 C2 Fab TnT 1 R1 T 1 1 T Fab TnT i30
3. 2014 1 1 Code No 472 11571 225AAAMX00226000 T LBA 1 2 3 4 T 1 100 1 1 R1 5 6 mL 2 2 R2 4 5 mL 3 3 R3 2 6 mL 4 4 R4 1 4 mL 5 1 C1 0 77 mL
4. 4 T T 1 20 EDTA
5. 2 1400 500 IU mL C 18 mg dL F 18 mg dL 450 mg dL 3 T i30 1 T 2 10 40
6. L H S 4 30 1 i30 2 T 30 3 1 T L H
7. 1 7 3 i30
8. 2 R2 3 R3 4 R4 1 C1 DNA Fab TnT FD 2 2 Waste TC1 DNA Fab TnT FT T Fab CTnT TR2 FD Detection Waste R2 R3 R4 C1 FD Detection 3 3 T Fab TnT C1 DNA Fab TnT a W WS Waste R3 R4 DNA DNA Fab TnT 0 3 Tn Fab Tn
9. 5 gt 1 2 121 20 1 500 2 000 ppm 60 T 2 10 1 472 11571 T 100 1 G Klein et al Clinical performance of the new cardiac markers Troponin T and CK MB wiener klinische wochenschrift 110 Suppl 3 1998 p 40 51 2
10. 605 0995 11 1 TEL 075 541 6317 479 11581 1 2 mLX2 1 2 mLX1 476 11591 L 2mLX4 479 11601 H 2mLX4 450 00921 20 X5 465 41791 60 mLX4 452 00501 S 1000 wa 1 Caliper TIN Caliper Life Sciences LBA EATA 11 721 TEL 075 541 6318 9 1 2 14 01 100 6
11. Human Anti mouse Antibody 2 J lt gt 1 T 0 ng mL 3 2SD T 0 01 ng mL 3 2SD 2 20 3 5 CV 15 4 0 01 25 ng mL gt gt r 0 995 n 182 r 0 994 n 141 Y 1 088X 0 001 Y 1 031X 0 001 Y ng mL ng mL x T T
12. T 40 5 1996 p 559 563 3 Tomohito Ohtani Yasunori Ueda et al Association between cardiac troponin T elevation and angioscopic morphology of culprit lesion in patients with non ST segment elevation acute coronary syndrome American Heart Journal 150 2 2005 p 227 233 4 ECLIA T 20 1997 p 347 354 5 Tomohisa Kawabata Mitsuo Watanabe Kenji Nakamura Shinji Satomura Liduid Phase Binding Assay of o Fetoprotein using DNA coupled antibody and capillary chip electrophoresis Anal Chem 2005 77 5579 5582 6 Tomohisa Kawabata Henry G Wada Mitsuo Watanabe Shinji Satomura Electrokinetic Analyte Transport Assay foro fetoprotein immunoassay integrates mixing reaction and separation on chip Electrophoresis 2008 29 1399 1406 7 Passing H Bablok W A new biometrical procedure for testing the equality of measurements from two different analytical methods J Clin Chem Clin Biochem 1983 21 11 709 20 103 0023 4 5 13 TEL 03 3270 9134
13. 8 FD FD T 640 nm 670 nm 2 B F Y T 0 1 ng mL lt gt 1
14. ng mL ng mL Passing Bablok gt 1 pH 11 2 HIV HBV HCV 3 gt 1 2 3 4
15. T DNA Fab TnT DNA Fab TnT 4 5 4 DNA Fab TnT T Fab TnT 5 6 DNA pd 4 DNA Fab TnT Fab TnT B F DNA Fab TnT B F 6 6 DNA
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