Test article and method for performing blood coagulation assays
First Claim
1. A test article comprising:
- a single permeable membrane having an application face and an opposite indicator face, said membrane being substantially free from interference with a coagulation pathway;
a coagulation initiator impregnated within the membrane; and
a substrate impregnated within the membrane, which substrate produces a detectable signal upon activation by a component of the coagulation pathway;
whereby whole blood may be applied to the application face of the membrane and a detectable signal is produced on the indicator face as a result of production of the component of the coagulation pathway.
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Accused Products
Abstract
A test article for determining coagulation capability in a blood sample comprises a porous membrane having a coagulation initiator and substrate impregnated therein. The pore dimensions and composition of the membrane may be selected so that only blood plasma can pass into the interior of the membrane, where coagulation is initiated. Alternatively, the substrate may be selected to have an emission and/or excitation wavelength which is not absorbed by hemoglobin. The substrate is activated by a component of the coagulation pathway, typically thrombin, and produces a detectable signal upon activation. By utilizing membrane matrix materials which are substantially free from interference with the coagulation pathway, accurate results can be achieved.
69 Citations
33 Claims
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1. A test article comprising:
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a single permeable membrane having an application face and an opposite indicator face, said membrane being substantially free from interference with a coagulation pathway; a coagulation initiator impregnated within the membrane; and a substrate impregnated within the membrane, which substrate produces a detectable signal upon activation by a component of the coagulation pathway; whereby whole blood may be applied to the application face of the membrane and a detectable signal is produced on the indicator face as a result of production of the component of the coagulation pathway. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 32)
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22. A inethod for determining coagulation capability of a patient, said method comprising:
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applying a whole blood sample to an application face of a permeable membrane, wherein the membrane is substantially free from interference with a coagulation pathway and wherein a coagulation initiator and a substrate which produces a detectable signal upon activation by a component of the coagulation pathway proteolytic enzyme are impregnated within the membrane; and detecting the signal at the indicator face of the membrane, wherein the indicator face is laterally opposed to the application face and the signal results from production of the coagulation pathway proteolytic enzyme within the membrane which had been initiated by interaction of the coagulation initiator with the blood sample. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 33)
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Specification