極めて低レベルの第 VIII 因子活性（FVIII:C）を定量するための改変合成
Contents
1. FVIII C 0 005 IU mL R ii O FVII C FVII C 2 0 001 0 02 U mL Fig 1 amp 2 DL QL 0 0005 0 0015 IU mL 0 0025 0 0076 IU mL 1 5 Fig 32. FVII R LNIBSC 7 AE 99 678 EL FVIIC 1 20 1 30 1 50 1 80 T 4 0 001 0 02 IU mL Coamatic 30 405 nm OD Fig 1 RC 1 30 ped enmity ents lt me T a 1 30 R gt 0 98 es KORNI Ree TA or Ko an 1 30 RELER 10 20 34 30 40 50 60 405 nm OD
3. 0 0015 IU mL FVII SHP h2 Fig 4 SHP FVII C FVII C ET A FVII C VII FVIIL C References 1 2 Over J Methodology of the one stage assay of FVIII FVII C Scand J Haematol 1984 33 11 24 Rosen S Andersson M Blomback M et al Clinical applications of a chromogenic substrate method for determ
4. DL 0 005 IU mL lt 9 Coamatic b Chromogenix Ca FIXa FX FXa FVIHI FXa S 2765 OE p PNA 405 nm FV FV 0 005 IU mL VII FVIIL C Coamatic 2 1 80 gt 1 30
5. Fig 2 yn 0 98 R Slope Inter 0 962 42 7 0 46 0 981 33 9 0 43 0 973 23 7 0 43 0 924 15 6 0 43 Ri T T T T 1 0 0 005 0 01 0 015 0 02 0 025 FVIII IU mL Fig 1 Effect of sample dilution A standard dilution set 0 001 0 02 IU mL of seventh international standard 99 678 factor VIII concentrate was analysed using a Coamatic chromogenic assay with final dilutions of 1 20 A 1 30 E 1 50 or 1 80 A and 30 min incubation with S 2765 substrate Data are mean SD of three independent experiments R slope and intercept values of each curve are indicated R Slope Inter 0 940 44 1 0 76 0 958 42 4 0 66 0 974 39 1 0 54 0 981 33 9 0 43 0 981 25 7 0 32 A 405 nm 0 984 15 2 0 21 0 0 005 0 01 0 015 0 02 0 025 FVIII IU mL Fig 2 Effect of development time A standard dilution set 0 001 0 02 IU mL of seventh international standard 99 678 factor VIII concentrate was analysed using a Coamatic chromogenic as say with incubations of 10 20 s 30 40 50 A or 60 A min with S 2765 substrate Data are mean SD of three independent experiments R slope and intercept values of each curve are indicated
6. 0 01 IU mL FVII C FIX C FVII FIX FVII FVIII J D FFI FIX X e H FIX C O FVIIIIC rotational thromboelas tography L FVIIC
7. FVII kit Chromo genix Milan Italy SE Z EL 25 mu pH 7 9 0 9 NaCl 1 BSA CaCl 6 7 mm 0 03 mm FIXa 0 05 U mL FX 0 45 IU mL 0 17 NIH U REA T SEAS S 2765 Xa 0 43 mg mL T 2581 0 011 mg mL FVIII SHP WT 0 1 IU mL Coamatic 0 0 001 0 0025 0 005 0 0075 0 01 0 015 0 02 IU mL 12 5 UL 1 mL 1 80 3 50uL 37 C 4
8. VII FVIIL C R 0 981 33 9 30 20 BEAR 1 30 30 1 80 10 1 80 k U 1 30 FV NIBSC 7 99 678 FVII C Fig 3 OD DL QL Fig 3
9. FVIT FVIILC FVII C FVII C 0 01 IU mL SHP DL FVII C 35 Full Translation R Yatuv et al a 1 4 5 R Slope Inter 0 976 34 0 0 43 0 963 32 8 0 26 Hi N A HH A 405 nm lt Co H te 0 0 005 0 01 0 015 0 02 0 025 FVIII IU mL b 1 0 9 0 8 0 7 1 4 0 976 34 0 a6 0 963 32 8 0 5 a 0 4 we 0 3 0 2 1 at 0 1 4 ee 0 G 0 0 005 0 01 0 015 0 02 0 025 FVIII IU mL R Slope A 405 nm Fig 4 Standard dose response in plasma and buffer A standard dilution set 0 001 0 02 IU mL of seventh international standard 99 678 factor VIII concentrate in a buffer gg and pool of plasma of haemophilic patients O were analysed using the modified protocol Data of OD values a and after subtraction of blank values of buffer and plasma b are mean SD of three independent experiments R slope and intercept values of each curve are indicated O
10. QL BE F FVIILC Correspondence Moshe Baru DSc Omri Laboratories Bldg 22 Weizmann Science Park Nes Ziona PO Box 619 Rehovot 76106 Israel Tel 972 8 9302970 fax 972 8 9302975 e mail moshe omrilabs co il Haemophilia 2006 12 253 257 Blackwell Publishing Ltd 32 0 0005 IU mL 0 0015 IU mL A Key words VI A FVII C 20 FIX FIXa FVII FXa EXa BOGE EEE ED Je OWWKELE FVIILC
11. Fig 3 0 9 R 0 981 0 8 Slope 33 9 DL 0 0005 0 7 QL 0 0015 g 0 6 c 2 0 5 q lt 0 4 0 3 R 0 939 Slope 6 6 0 2 DL 0 0025 ne QL 0 0076 0 T T T T 1 0 0 005 0 01 0 015 0 02 0 025 FVIII IU mL Fig 3 Direct comparison of original and modified protocol A standard dilution set 0 001 0 02 IU mL of seventh interna tional standard 99 678 factor VIII concentrate in a buffer was analysed using a Coamatic chromogenic assay with the original or the modified protocols Data are mean SD of three independent experiments Blank values buffer only were sub tracted from both curves R slope DL and QL values of each curve are indicated DL QL 0 0005 0 0015 0 0023 0 0076 1 5 0 981 0 939 SHP FVIII C SHP FVII FVII C SHP i FVIII C FVU 99
12. 50 zL 377C 4 S 276S 50 UL 377C 10 20 50L VERSA max Molecular Devices tk pNA 405 nm S 2765 Coamatic 2 50 33 20zL 1 mL 3 1 20 1 30 BLU 1 50 1 80 2 LT 20 30 40 50
13. E 10 30 DL 0 0005 IU mL QL 0 0015 IU mL FVIHC A FVII REMI National Institute for Biological Standards and Con trol NIBSC FVIII 7 FVIII L 2003 11 WHO Expert Committee on Biological Standard ization severe hae mophilia patients SHP 7 Y Mil HRF Inc Coamatic
14. factors should influence the dosage and interval of prophylactic treatment in patients with severe haemophilia A or B Haemophilia 2001 7 91 102 Roth DA Tawa NMD O Brien JM Treco DA and Selden R Nonviral transfer of the gene encoding factor VIII in patients with sever hemophilia A N Engl J Med 2001 344 1731 42 Manno CS Chew AJ Larson PJ et al AAV mediated factor IX gene transfer to skeletal muscle in patients with severe hemophilia B Blood 2003 101 2961 72 37
15. 60 10 OD FVII C Ezxcel 2002 GraphPad Prism Program Version 4 02 GraphPad Software 33 Full Translation R Yatuv et al DL QL International Conference on Harmonisation of Technical Requirements for Reg istration of Pharmaceuticals for Human Use ICH Paes of Analytical Procedures ICH Q2A 10 SHP IMEDA 10 DL QL DL 3 3 QL 10 X FVII C
16. 678 SHP Mi T 0 1 IU mL SHP ME E 7 SHB MZ INA 0 001 0 02 IU mL UERR ERM Leo TN CORRE RR ATER C 1 30 3 Fig 44 Fig 4b Fig 44 Fig 4b SHP FVII FV 2 FVII 34 SHP i 4 P FVII 32 8 Fig 4a 2 SHP OD SHP Fig 4b COREA MAE TO SHPO FVILC 5 R
17. Original Article Full Translation VIII FVIII C EDA A modified chromogenic assay for the measurement of very low levels of factor VIII activity FVIII C R Yatuv I Dayan and M Baru Omri Laboratories Ltd Weizmann Science Park Nes Ziona Rehovot Israel BK MD CLV O mE E VT FVII 0 001 0 02 IU mL eit VTI AF FVII FVII C A FVIIIC RAK ean FVII C 2 0 01 IU mL
18. ination of FVIII activity Thromb Haemost 1985 54 811 23 McIntosh JH Owens D Lee CA Raut S Barrowcliffe TW A modified thrombin generation test for the measurement of factor VIII concentrates Thromb Haemost 2003 1 1005 11 Beltran Miranda CP Khan A Jaloma Cruz AR and Laffan MA Thrombin generation and phenotypic correlation in haemophilia A Heamophilia 2005 11 321 34 Shima M Matsumoto T Fukuda K et al The utility of activated partial thromboplastin time aPTT clot waveform analysis in the investigation of hemophilia A patients with very low levels of FVII activity FVII C Thromb Haemost 2002 87 431 41 Barrowcliffe TW Monitoring haemophilia severity and treatment new or old laboratory tests Haemophilia 2004 10 101 14 ICH International Conference on Harmonisation of 10 11 12 Technical Requirements for Registration of Pharma ceuticals for Human Use ICH Harmonized Tripartite Guideline Validation of Analytical Procedures Meth odology O2B 1996 http www ich org Baru M Carmel Goren L Barenholz Y et al Factor VIII efficient and specific non covalent binding to PEGylated liposomes enables prolongation of its circulation time and haemostatic activity Thromb Haemost 2005 93 1061 8 Ingerslev J Poulsen LH and Sorensen B Potential role of the dynamic properties of whole blood coagulation in assessment of dosage requirements in haemophilia Haemophilia 2003 9 341 52 Petrini P What
Download Pdf Manuals
Related Search