Test articles for performing dry reagent prothrombin time assays

Claim 2

A test article for performing dry reagent prothrombin time assays, said test article comprising a solid phase matrix; dry thromboplastin immobilized on or within the solid phase matrix, wherein the thromboplastin is substantially free from substances found in thromboplastin purified from brain extract which cause aberrant functioning intermediate transition states as the thromboplastin is rehydrated with liquid sample; and coagulation neutral agents which facilitate rehydration of the thromboplastin upon contact of the solid phase matrix with the liquid sample.

Claim 3

A test article as in claim 1, wherein the dry thromboplastin is relipidated recombinant tissue factor.

Claim 4

A test article as in claim 1, wherein the coagulation neutral agents are selected from the group consisting of albumins, water soluble polymers, and surfactants.

Claim 5

A test strip comprising: a permeable membrane having an application face and an indicator face in lateral opposition, said membrane being substantially free from an interference with a thromboplastin-initiated and factor VII or VIIa mediated coagulation pathway; coagulation neutral agents which facilitate liquid sample uptake and distribution into the membrane; dry thromboplastin impregnated within the membrane, wherein the thromboplastin is substantially free from substances found in thromboplastin purified from brain extract which cause aberrant intermediate transition states as the thromboplastin is rehydrated with liquid sample; and a substrate impregnated within the membrane, which substrate produces a detectable signal upon activation by a component of the coagulation pathway; whereby coagulation factor VII or VII(a) containing samples may be applied to the application face of the membrane in order to produce the detectable signal on the indicator face as a result of activation of the substrate by the coagulation pathway component.

Claim 6

A test strip comprising: a permeable membrane having an application face and an indicator face in lateral opposition, said membrane being substantially free from an interference with a thromboplastin-initiated and factor VII or VIIa mediated coagulation pathway; coagulation neutral agents which facilitate liquid sample uptake and distribution into the membrane; dry thromboplastin impregnated within the membrane, wherein the thromboplastin is substantially free from substances found in thromboplastin purified from brain extract which cause aberrant intermediate transition states as the thromboplastin is rehydrated with liquid sample; and a substrate impregnated within the membrane, which substrate produces a detectable signal upon activation by a component of the coagulation pathway; whereby coagulation factor VII or VII(a) containing samples may be applied to the application face of the membrane in order to produce the detectable signal on the indicator face as a result of activation of the substrate by the coagulation pathway component.

Claim 7

The test strip as in claim 4, wherein the dry thromboplastin is relipidated recombinant tissue factor.

Claim 8

The test strip as in claim 4, wherein the coagulation neutral agents are selected from the group consisting of albumins, water soluble polymers, and surfactants.

Claim 9

An improved prothrombin time assay of the type wherein a blood or plasma sample is applied to a solid phase matrix to contact dry thromboplastin to initiate a detectable reaction, wherein the improvement comprises providing a coagulation neutral agent within the matrix and contacting a dry thromboplastin which is substantially free from substances found in thromboplastin purified from brain extract which cause aberrant functioning transition states as the thromboplastin is rehydrated with the sample.

Claim 10

An improved prothrombin time assay of the type wherein a blood or plasma sample is applied to a solid phase matrix to contact dry thromboplastin to initiate a detectable reaction, wherein the improvement comprises providing a coagulation neutral agent within the matrix and contacting a dry thromboplastin which is substantially free from substances found in thromboplastin purified from brain extract which cause aberrant functioning transition states as the thromboplastin is rehydrated with the sample.

Claim 11

An improved prothrombin time assay as in claim 7, wherein the dry thromboplastin is relipidated recombinant tissue factor.

Claim 12

An improved prothrombin time assay as in claim 7, wherein the coagulation neutral agent is selected from the group consisting of albumins, water soluble polymers, and surfactants.