Test strip apparatus and method for determining presence of analyte in a fluid sample
First Claim
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1. A semiquantitative method for determining the presence of an analyte in a sample fluid, comprisingexposing a portion of a test strip apparatus to said sample fluid to be tested, wherein said test strip apparatus comprises:
- a conjugate pad comprising a diffusible labelled first binding partner that binds with said analyte;
a first area comprising an immobilized second binding partner that competes with said analyte to bind with said diffusible labelled first binding partner; and
a second area comprising an immobilized third binding partner that binds with said diffusible labelled first binding partner,located in sequence in a capillary fluid flow direction in said test strip apparatus;
allowing said analyte in said sample fluid to migrate up the test strip apparatus by capillary action; and
reading a result of said test strip by comparing relative label intensities in said first area and said second area,wherein a greater relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount greater than a value determined by the amounts of said first and second binding partners and a lesser relative intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount less than a value determined by the amounts of said first and second binding partners.
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Abstract
An apparatus in the form of a test strip is useful for determining the presence of one or more components in a fluid sample. The test strip can be used by itself or in conjunction with an associated housing assembly. The test strip provides a rapid volume, timing and temperature independent visually readable strip for the semi-quantitative detection of a component, such as an analyte.
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Citations
48 Claims
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1. A semiquantitative method for determining the presence of an analyte in a sample fluid, comprising
exposing a portion of a test strip apparatus to said sample fluid to be tested, wherein said test strip apparatus comprises: -
a conjugate pad comprising a diffusible labelled first binding partner that binds with said analyte; a first area comprising an immobilized second binding partner that competes with said analyte to bind with said diffusible labelled first binding partner; and a second area comprising an immobilized third binding partner that binds with said diffusible labelled first binding partner, located in sequence in a capillary fluid flow direction in said test strip apparatus; allowing said analyte in said sample fluid to migrate up the test strip apparatus by capillary action; and reading a result of said test strip by comparing relative label intensities in said first area and said second area, wherein a greater relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount greater than a value determined by the amounts of said first and second binding partners and a lesser relative intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount less than a value determined by the amounts of said first and second binding partners. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A test strip apparatus for semiquantitative determination of an analyte in a sample fluid, comprising
a sample pad; -
a conjugate pad comprising a diffusible labelled first binding partner that binds with said analyte; a first area comprising an immobilized second binding partner that competes with said analyte to bind with said diffusible labelled first binding partner, wherein there is a sufficient amount of said second binding partner to bind at least 80%, but no more than 99%, of said labelled first binding partner in an absence of said analyte in said sample fluid; a second area comprising an immobilized third binding partner that binds with said diffusible labelled first binding partner; and a draw wick pad, located in sequence in a capillary fluid flow direction in said test strip apparatus, wherein when said test strip is exposed to said sample fluid, a greater relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount greater than a value determined by the amounts of said first and second binding partners and a lesser relative intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount less than a value determined by the amounts of said first and second binding partners. - View Dependent Claims (18, 19, 20, 21)
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22. A semiquantitative method for determining the presence of an analyte in a sample fluid, comprising
exposing a portion of a test strip apparatus to said sample fluid to be tested, wherein said test strip apparatus comprises: -
a conjugate pad comprising a diffusible labelled first binding partner that binds with said analyte; a first area comprising an immobilized second binding partner that binds with analyte which has bound to said diffusible labelled first binding partner to form an analyte sandwich, but does not bind with said diffusible labelled first binding partner; and a second area comprising an immobilized third binding partner that binds with said diffusible labelled first binding partner, located in sequence in a capillary fluid flow direction in said test strip apparatus; allowing said analyte in said sample fluid to migrate up the test strip apparatus by capillary action; and reading a result of said test strip by comparing relative label intensities in said first area and said second area, wherein a greater relative label intensity in said first area as compared to said second area indicates the presence of said analyte in said sample fluid in an amount greater than a value determined by the amounts of said first, second and third binding partners and a lesser relative label intensity in said first area as compared to said second area indicates the presence of said an analyte in said sample fluid in an amount less than a value determined by the amounts of said first, second and third binding partners. - View Dependent Claims (23)
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24. A semiquantitative method for determining the presence of an analyte in a sample fluid, comprising
exposing a portion of a test strip apparatus to said sample fluid to be tested, wherein said test strip apparatus comprises: -
a conjugate pad comprising a diffusible labelled form of said analyte; a first area comprising an immobilized first binding partner that binds with said analyte and said labelled form of said analyte; and a second area comprising an immobilized second binding partner that binds with any of said analyte not bound to said immobilized first binding partner, located in sequence in a capillary fluid flow direction in said test strip apparatus; allowing said analyte in said sample fluid to migrate up the test strip apparatus by capillary action; and reading a result of said test strip by comparing relative label intensities in said first area and said second area, wherein a greater relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount greater than a value determined by the amount of said first binding partner and a lesser relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount less than a value determined by the amount of said first binding partner. - View Dependent Claims (25, 26, 27, 28)
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29. A test strip apparatus for determining the presence of an analyte in a sample fluid, comprising
a sample pad; -
a conjugate pad comprising a diffusible labelled first binding partner that binds with said analyte; a metering component; a first area comprising an immobilized second binding partner that competes with said analyte to bind with said diffusible labelled first binding partner; a second area comprising an immobilized third binding partner that binds with said diffusible labelled first binding partner; and a draw wick pad, located in sequence in a capillary fluid flow direction in said test strip apparatus. - View Dependent Claims (30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
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44. A semiquantitative method for determining the presence of an analyte in a sample fluid, comprising
exposing a portion of a test strip apparatus to said sample fluid to be tested, wherein said test strip apparatus comprises: -
a conjugate pad comprising a diffusible labelled first binding partner that binds with said analyte; a metering component; a first area comprising an immobilized second binding partner that competes with said analyte to bind with said diffusible labelled first binding partner; and a second area comprising an immobilized third binding partner that binds with said diffusible labelled first binding partner, located in sequence in a capillary fluid flow direction in said test strip apparatus; allowing said analyte in said sample fluid to migrate up the test strip apparatus by capillary action; and reading a result of said test strip by comparing relative label intensities in said first area and said second area, wherein a greater relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount greater than a value determined by the amounts of said first and second binding partners and said metering component and a lesser relative label intensity in said second area as compared to said first area indicates the presence of said analyte in said sample fluid in an amount less than a value determined by the amounts of said first and second binding partners and said metering component. - View Dependent Claims (45, 46, 47, 48)
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Specification