Test apparatus and methods for ST2 cardiac biomarker
First Claim
1. A test system for ST2 cardiac biomarker, comprising:
- a test strip configured to facilitate detection of a threshold level of ST2 in blood plasma;
a housing for the test strip, wherein the housing comprises;
a first section comprising an outer face and an inner face, wherein the inner face of the first section comprises a channel to receive the test strip along the length of the first section, anda second section comprising an outer face and an inner face, wherein the second section is configured to be attached to the first section such that in an attached configuration the inner face of the first section faces the inner face of the second section, and the first and second sections together enclose the test strip within the housing, wherein the second section comprises;
a buffer port configured to allow a buffer solution to be dispensed to a portion of the test strip proximate to a first end of the test strip,a test window configured to facilitate imaging of one or both of a test location and a control location on the test strip,a sample port disposed between the buffer port and the test window, the sample port configured to enable a sample of blood plasma to be dispensed to the test strip, anda set of projections disposed on the inner face of the second section between the test window and the sample port such that in the attached configuration, each projection in the set of projections is in contact with the test strip, wherein a height of at least one projection in the set of projections is different from a height of another projection in the set of projections, and heights of the different projections are configured such that, in the attached configuration, the set of projections produces a pressure gradient within the test strip that allows a fluid to flow at a predetermined flow rate along the length of the test strip between the first and last projections in the set of projections;
an identification tag disposed on or within the housing, wherein the identification tag is configured to store identification information about a patient or sample associated with the test strip; and
a reader device configured to accept at least a portion of the housing within the reader device, the reader device comprising an optical system that images one or both of the test location and the control location on the test strip, and displays an estimated level of ST2 in the sample of blood plasma.
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Accused Products
Abstract
The technology described in this document can be embodied in a test strip for use in measuring a level of an ST2 cardiac biomarker in a blood plasma sample. The test strip includes a base, and a plurality of conjugates, wherein each conjugate includes a reporter group bound to a first antibody that binds to ST2. A conjugate pad disposed along a length of the base and is configured to hold the plurality of conjugates that bind with ST2 to produce conjugate-ST2 complexes. The conjugate pad is further configured to receive the blood plasma sample. The test strip also includes a plurality of second and third antibodies that bind to ST2, and the conjugate-ST2 complexes, respectively. The plurality of second antibodies are bound to a membrane in a test location and the plurality of third antibodies are bound to the membrane in a control location.
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Citations
17 Claims
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1. A test system for ST2 cardiac biomarker, comprising:
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a test strip configured to facilitate detection of a threshold level of ST2 in blood plasma; a housing for the test strip, wherein the housing comprises; a first section comprising an outer face and an inner face, wherein the inner face of the first section comprises a channel to receive the test strip along the length of the first section, and a second section comprising an outer face and an inner face, wherein the second section is configured to be attached to the first section such that in an attached configuration the inner face of the first section faces the inner face of the second section, and the first and second sections together enclose the test strip within the housing, wherein the second section comprises; a buffer port configured to allow a buffer solution to be dispensed to a portion of the test strip proximate to a first end of the test strip, a test window configured to facilitate imaging of one or both of a test location and a control location on the test strip, a sample port disposed between the buffer port and the test window, the sample port configured to enable a sample of blood plasma to be dispensed to the test strip, and a set of projections disposed on the inner face of the second section between the test window and the sample port such that in the attached configuration, each projection in the set of projections is in contact with the test strip, wherein a height of at least one projection in the set of projections is different from a height of another projection in the set of projections, and heights of the different projections are configured such that, in the attached configuration, the set of projections produces a pressure gradient within the test strip that allows a fluid to flow at a predetermined flow rate along the length of the test strip between the first and last projections in the set of projections; an identification tag disposed on or within the housing, wherein the identification tag is configured to store identification information about a patient or sample associated with the test strip; and a reader device configured to accept at least a portion of the housing within the reader device, the reader device comprising an optical system that images one or both of the test location and the control location on the test strip, and displays an estimated level of ST2 in the sample of blood plasma. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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Specification