Comparison of coagulant activity of factor VII and activated factor VII activity assays when used for determination of recombinant activated factor VII levels in plasma.

Comparison of coagulant activity of factor VII and activated factor VII activity assays when used for determination of recombinant activated factor VII levels in plasma. Research Abstract Details 

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Comparison of coagulant activity of factor VII and activated factor VII activity assays when used for determination of recombinant activated factor VII levels in plasma. Abstract Text:

Birgitte Scharling,Gert G Nielsen,Thomas Klitgaard,Thor Aa Skovsted,Judi ,Stine Segel,Lone Frost Larsen,Birgitte Scharling,Gert G Nielsen,Thomas Klitgaard,Thor Aa Skovsted,Judi ,Stine Segel,Lone Frost Larsen,

Two assays [coagulant activity of factor VII (FVII:C) and activated factor VII (FVIIa) activity] are currently available for the assessment of factor VII and FVIIa pharmacokinetics. This article presents the results of a comparison of the two assays when applied both in vitro as well as during clinical pharmacokinetic trials of recombinant FVIIa (rFVIIa) administered to healthy individuals and haemophilia patients. The in-vitro data showed that, for the FVII:C assay, plasma samples do not dilute in parallel. For the FVIIa activity assay, dilutions of samples are both parallel and linear with different dilutions of the calibrator. Moreover, intra-assay variation was found to be smaller for the FVIIa activity assay than for the FVII:C assay. When adding different amounts of rFVIIa (0-6 microg/ml) to normal plasma, a mean specific activity of rFVIIa of 48.6 U/mug was observed on applying the FVII:C assay; however, the specific activity decreased with increasing levels of rFVIIa. For the FVIIa activity assay, the mean specific activity was 45.4 IU/mug. Direct comparison of the two activity assays showed that no simple conversion between FVII:C and FVIIa activity measurements are possible. When applying the two assays for pharmacokinetic assessments in two clinical trials, statistically significant different estimates for the area under the curve, half-life, clearance and volume of distribution were obtained. In conclusion, for evaluation of rFVIIa pharmacokinetic properties, activity should be measured with the FVIIa activity assay - which is a more specific and reliable assay of the two available factor VII activity assays, especially when assessing low activity levels.

Comparison of coagulant activity of factor VII and activated factor VII activity assays when used for determination of recombinant activated factor VII levels in plasma. Publishing Authors By Initials

B Scharling,GG Nielsen,T Klitgaard,TA Skovsted,J ,S Segel,LF Larsen,B Scharling,GG Nielsen,T Klitgaard,TA Skovsted,J ,S Segel,LF Larsen,

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Comparison of coagulant activity of factor VII and activated factor VII activity assays when used for determination of recombinant activated factor VII levels in plasma. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: Blood coagulation & fibrinolysis : an internationa

VOLUME: 18

Page Numbers: 677-84

Journal Abbreviation: Blood Coagul. Fibrinolysis

ISSN: 0957-5235

DAY: 24

MONTH: Oct

YEAR: 2007

Comparison of coagulant activity of factor VII and activated factor VII activity assays when used for determination of recombinant activated factor VII levels in plasma. Information

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LANGUAGE: eng

NlmUniqueID: 9102551

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Grant and Affiliation Information for Comparison of coagulant activity of factor VII and activated factor VII activity assays when used for determination of recombinant activated factor VII levels in plasma.

AFFILIATION: Novo Nordisk A/S, Bagsvaerd, Denmark. Bish@novonordisk.com

Country: England

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MEDLINETA: Blood Coagul Fibrinolysis

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