Patent US6001658A successfully refreshed from Google Patents.
US6001658A
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US
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Test strip apparatus and method for determining presence of analyte in a fluid sample
Assignee: Sekisui Diagnostics LLC
•
Filing: 1996-09-13
•
Granted: 1999-12-14
•
Expires: 2016-09-13
Abstract
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.
Inventors
- 👤 Robert A. Fredrickson
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 09:11
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/81; Y10S435/97; Y10S436/00; Y10S436/805; Y10S436/807; Y10S436/81
Claims Analysis
Total Claims: 54
Claim 1
Independent Claim
232 words
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.
Claim 2
Dependent Claim
232 words
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.
Claim 3
Dependent Claim
34 words
A method according to claim 1, wherein in an absence of said analyte in said sample fluid, at least 80% of said diffusible labelled first binding partner binds to said immobilized second binding partner.
Claim 4
Dependent Claim
51 words
A method according to claim 1, wherein said diffusible labelled first binding partner comprises an antibody-latex microparticle conjugate, said immobilized second binding partner comprises human serum albumin, said immobilized third binding partner comprises an anti-mouse antibody capable of binding with said antibody-latex microparticle conjugate, and said analyte is human urine albumin.
Claim 5
Dependent Claim
55 words
A method according to claim 1, wherein said test strip apparatus further comprises a sample pad located upstream of said diffusible labelled first binding partner in said capillary fluid flow direction, and a draw wick pad located downstream of said immobilized third binding partner in said capillary fluid flow direction in said test strip apparatus.
Claim 6
Dependent Claim
25 words
A method according to claim 1, wherein said immobilized second binding partner is selected from the group consisting of immobilized analyte and immobilized analyte analog.
Claim 7
Dependent Claim
34 words
A method according to claim 1, wherein in an absence of said analyte in said sample fluid, at least 95% of said diffusible labelled first binding partner binds to said immobilized second binding partner.
Claim 8
Dependent Claim
18 words
A method according to claim 1, wherein said diffusible labelled first binding partner comprises an antibody-colloidal gold conjugate.
Claim 9
Dependent Claim
17 words
A method according to claim 1, wherein said diffusible labelled first binding partner is an antibody-label conjugate.
Claim 10
Dependent Claim
17 words
A method according to claim 1, wherein said diffusible labelled first binding partner comprises a visible label.
Claim 11
Dependent Claim
13 words
A method according to claim 9, wherein said visible label comprises latex microparticles.
Claim 12
Dependent Claim
15 words
A method according to claim 1, wherein said immobilized third binding partner comprises an antibody.
Claim 13
Dependent Claim
62 words
A method according to claim 1, wherein said test strip apparatus further comprises a metering component directed against said analyte to sequester a portion of said analyte to meter a concentration of said analyte in said sample fluid, wherein said metering component is located in said test strip apparatus upstream of said immobilized second binding partner in said capillary fluid flow direction.
Claim 14
Dependent Claim
14 words
A method according to claim 12, wherein said metering component is an unlabelled antibody.
Claim 15
Dependent Claim
34 words
The method of claim 1, wherein said first area comprises sufficient immobilized second binding partner to bind 80-99% of said labelled first binding partner in an absence of said analyte in said sample fluid.
Claim 16
Dependent Claim
34 words
The method of claim 1, wherein said first area comprises sufficient immobilized second binding partner to bind 90-99% of said labelled first binding partner in an absence of said analyte in said sample fluid.
Claim 17
Dependent Claim
35 words
The method of claim 1, wherein said first area comprises sufficient immobilized second binding partner to bind about 95% of said labelled first binding partner in an absence of said analyte in said sample fluid.
Claim 18
Dependent Claim
227 words
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.
Claim 19
Dependent Claim
227 words
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.
Claim 20
Dependent Claim
47 words
A test strip apparatus according to claim 17, wherein said diffusible labelled first binding partner comprises an antibody-latex microparticle conjugate, said immobilized second binding partner comprises human serum albumin, and said immobilized third binding partner comprises an anti-mouse antibody capable of binding with said antibody-latex microparticle conjugate.
Claim 21
Dependent Claim
34 words
The apparatus of claim 17, wherein there is a sufficient amount of said second binding partner to bind 90-99% of said first binding partner in an absence of said analyte in said sample fluid.
Claim 22
Dependent Claim
35 words
The apparatus of claim 17, wherein there is a sufficient amount of said second binding partner to bind about 95% of said first binding partner in an absence of said analyte in said sample fluid.
Claim 23
Dependent Claim
24 words
The apparatus of claim 17, wherein said immobilized second binding partner is selected from the group consisting of immobilized analyte and immobilized analyte analog.
Claim 24
Dependent Claim
252 words
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.
Claim 25
Dependent Claim
252 words
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.
Claim 26
Dependent Claim
43 words
The method of claim 22, wherein said immobilized second binding partner is selected from the group consisting of immobilized antibody to said analyte and an antibody recognizing a different epitope on said analyte than the epitope recognized by said labelled first binding partner.
Claim 27
Dependent Claim
229 words
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.
Claim 28
Dependent Claim
229 words
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.
Claim 29
Dependent Claim
32 words
The method of claim 24, wherein said first area comprises sufficient immobilized first binding partner to bind 80-99% of said labelled analyte in an absence of said analyte in said sample fluid.
Claim 30
Dependent Claim
32 words
The method of claim 24, wherein said first area comprises sufficient immobilized first binding partner to bind 90-99% of said labelled analyte in an absence of said analyte in said sample fluid.
Claim 31
Dependent Claim
33 words
The method of claim 24, wherein said first area comprises sufficient immobilized first binding partner to bind about 95% of said labelled analyte in an absence of said analyte in said sample fluid.
Claim 32
Dependent Claim
30 words
The method of claim 24, wherein said immobilized first binding partner is selected from the group consisting of immobilized polyclonal antibody against said analyte and monoclonal antibody against said analyte.
Claim 33
Dependent Claim
97 words
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.
Claim 34
Dependent Claim
97 words
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.
Claim 35
Dependent Claim
43 words
The apparatus of claim 29, wherein in an absence of said analyte in said sample fluid, at least 80% of said diffusible labelled first binding partner binds to said immobilized second binding partner in an absence of said analyte in said sample fluid.
Claim 36
Dependent Claim
50 words
The apparatus of claim 29, wherein said diffusible labelled first binding partner comprises an antibody-latex microparticle conjugate, said immobilized second binding partner comprises human serum albumin, said immobilized third binding partner comprises an anti-mouse antibody capable of binding with said antibody-latex microparticle conjugate, and said analyte is human urine albumin.
Claim 37
Dependent Claim
24 words
The apparatus of claim 29, wherein said immobilized second binding partner is selected from the group consisting of immobilized analyte and immobilized analyte analog.
Claim 38
Dependent Claim
43 words
The apparatus of claim 29, wherein in an absence of said analyte in said sample fluid, at least 95% of said diffusible labelled first binding partner binds to said immobilized second binding partner in an absence of said analyte in said sample fluid.
Claim 39
Dependent Claim
17 words
The apparatus of claim 29, wherein said diffusible labelled first binding partner comprises an antibody-colloidal gold conjugate.
Claim 40
Dependent Claim
16 words
The apparatus of claim 29, wherein said diffusible labelled first binding partner is an antibody-label conjugate.
Claim 41
Dependent Claim
16 words
The apparatus of claim 29, wherein said diffusible labelled first binding partner comprises a visible label.
Claim 42
Dependent Claim
12 words
The apparatus of claim 36, wherein said visible label comprises latex microparticles.
Claim 43
Dependent Claim
14 words
The apparatus of claim 29, wherein said immobilized third binding partner comprises an antibody.
Claim 44
Dependent Claim
32 words
The apparatus of claim 29, wherein said metering component is directed against said analyte to sequester a portion of said analyte to meter a concentration of said analyte in said sample fluid.
Claim 45
Dependent Claim
13 words
The apparatus of claim 39, wherein said metering component is an unlabelled antibody.
Claim 46
Dependent Claim
15 words
The apparatus of claim 29, wherein said metering component is contained in said conjugate pad.
Claim 47
Dependent Claim
15 words
The apparatus of claim 29, wherein said metering component is contained in said sample pad.
Claim 48
Dependent Claim
27 words
The apparatus of claim 29, wherein said metering component is contained in a metering pad located prior to said first area in said capillary fluid flow direction.
Claim 49
Dependent Claim
244 words
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.
Claim 50
Dependent Claim
244 words
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.
Claim 51
Dependent Claim
24 words
The method of claim 44, wherein said immobilized second binding partner is selected from the group consisting of immobilized analyte and immobilized analyte analog.
Claim 52
Dependent Claim
15 words
The method of claim 44, wherein said metering component is contained in said conjugate pad.
Claim 53
Dependent Claim
15 words
The method of claim 44, wherein said metering component is contained in said sample pad.
Claim 54
Dependent Claim
27 words
The method of claim 44, wherein said metering component is contained in a metering pad located prior to said first area in said capillary fluid flow direction.
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