Assays for determining anticoagulant cofactor activity

A method for diagnosing a blood coagulation/anticoaoulation disorder, preferably a thromboembolic disorder, or for determining predisposition therefor, in an individual, preferably a mammal, such as a human being, said method comprising determining the level of a blood component expressing anticoagulant activity in a sample, preferably a blood or blood derived sample, such as plasma, derived from said individual, said blood component being comprised of Factor V, an abnormal level indicating manifestation of, or predisposition for, said disorder, for a decreased level said disorder preferably being a thromboembolic disorder.

An antibody preparation reacting specifically with a region or site of Factor V that may carry an epitope associated with its anticoagulant activity as cofactor to APC.

Antibody preparation comprising polyclonal antibodies that recognize and selectively bind to Factor V, preferably to a region or site of Factor V associated with its anticoagulant activity as cofactor to APC, said region or site optionally comprising an epitope for said activity.

A cell line producing [monoclonal] antibodies reacting specifically with a region or site of Factor V that may carry an epitope associated with its anticoagulant activity as cofactor to APC.

Use of Factor V, subunits or fragments thereof, having anticoagulant activity as a cofactor to APC for the manufacture of a medicament or pharmaceutical preparation for enhancing, or restoring to normal, in an individual the anticoagulant activity of Protein C, APC, Factor V or Protein S, or any combination thereof.

A plasma package preparation intended for the determination in vitro of anticoagulant activity of Factor V, as cofactor to APC, said preparation being comprised of human plasma, which has been made deficient in said anticoagulant activity, e.g. by immune depletion with respect to Factor V, capable of expressing said activity, said plasma optionally being supplemented with Factor V, e.g. bovine Factor V, from a species inherently lacking said anticoagulant activity, or with Factor Va or said preparation being comprised of human plasma from one or more individuals, whose plasma is deficient in said activity.

A plasma package preparation intended for determination in vitro of anticoagulant activity of Factor V as cofactor to APC, said preparation being a mixture of plasma from individuals having partial deficiency in Factor V anticoagulant activity, said mixture being capable to express said anticoagulant activity at a suitable low level, e.g. for use as control plasma.

A plasma deficient in anticoagulant activity of Factor V as cofactor to APC, said plasma being comprised of human plasma, which has been made deficient in said anticoagulant activity, e.g. by immune depletion with respect to Factor V capable of expressing said activity, said plasma optionally being supplemented with Factor V, e.g. bovine Factor V, from species inherently lacking said anticoagulant activity, or with Factor Va, or being comprised of human plasma from one or more individuals, whose plasma is deficient in said activity.

A Protein S preparation intended for the determination of anticoagulant activity of Factor V as cofactor to APC.

A Protein C preparation, optionally in activated form or combined with an activator for Protein C, intended for the determination of anticoagulant activity of Factor V as cofactor to APC.

Use of Protein C/activated Protein C or Protein S for the manufacture of a pharmaceutical composition intended for the treatment of a disorder related to functional disturbances in levels of anticoagulant activity of Factor V as cofactor to APC.

Factor V, suitably human Factor V, capable of becoming activated to exert Factor Va procoagulant activity but not capable of exerting anticoagulant activity, preferentially not anticoagulant activity as a cofactor to APC, said factor being in a substantially pure form.

Factor V, suitably human Factor V, capable of exerting anticoagulant activity, preferentially as a cofactor to APC, but not capable of expressing procoagulant activity of Factor Va.