Test articles for performing dry reagent prothrombin time assays

• US 5,418,141 A
• Filed: 05/06/1994
• Issued: 05/23/1995
• Est. Priority Date: 05/06/1994
• Status: Expired due to Term

• Current Assignee: Beckman Coulter Incorporated (Danaher Corporation)
• Original Assignee: Avocet Medical, Inc.
• Inventors: Sharma, Sameer, Zweig, Stephen E., Meyer, Benjamin G.
• Primary Examiner(s): Wityshyn, Michael G.
• Assistant Examiner(s): GITOMER, RALPH J
• Application Number:
  US08/238,842
• Time in Patent Office: 382 Days
• Field of Search: 435/13, 435/176, 435/177, 435/180, 435/182, 435/212, 435/214, 435/805, 422/56, 422/57, 422/60, 436/69, 530/381, 530/384
• US Class Current: 435/13
• CPC Class Codes: C07K 14/745 Blood coagulation or fibrinolysis factors
• CPC Class Codes: C12Q 1/56 involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• CPC Class Codes: G01N 2333/745 Assays involving non-enzymic blood coagulation factors
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

Test articles comprise a solid phase membrane having dry thromboplastin immobilized thereon or within. The thromboplastin is substantially free from substances which might cause aberrant functioning intermediate transition states as the thromboplastin is rehydrated with liquid sample. Coagulation neutral agents which facilitate rehydration of the dry thromboplastin are also provided on the solid phase membrane.

Claims

1. 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.

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

3. 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.

4. 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.

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

6. 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.

7. 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.

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

9. 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.