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EP0342913B1
Expired / Lapsed
EP
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Method for immunochromatographic analysis
Assignee: Syntex USA LLC
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Filing: 1989-05-16
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Granted: 1995-08-23
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Expires: 2009-05-16
Abstract
Abstract Methods are disclosed for conducting assays. One such method comprises providing in combination a first bibulous member zone ("first zone") and a liquid medium containing a component. The first zone has non-diffusively bound thereto a reagent interreactive with the component. Conditions are selected wherein the liquid medium and at least a portion of the component contained therein traverse all of the first zone and migrate into a second bibulous member zone ("second zone") of a different composition than the first zone by capillary migration. The distance the component has migrated into the second zone or the difference in the distances the medium and the component have migrated into the second zone is determined, the distance or the difference being related to the amount of the component in the liquid medium or the amount of the reagent. Another such method comprises causing a specific binding pair member in a first liquid medium to become bound to a first bibulous member by contacting a portion of the first bibulous member with the medium. The first bibulous member is in liquid receiving relationship with an absorbent member. The contacting is carried out under conditions wherein the first medium traverses the first bibulous member and at least a portion of the absorbent member by capillary action. The method further comprises causing the first bibulous member to come into liquid receiving relationship with a second bibulous member. A component in a second liquid medium is transported to and preferably becomes non-diffusively bound to the second bibulous member in relation to the presence of analyte in the first medium. This is accomplished by contacting a portion of the first bibulous member with the second medium under conditions wherein the second medium traverses the first bibulous member by capillary action and at least a portion of the second bibulous member. Next, the presence of the component on at least a portion of the second bibulous member is determined.
Inventors
- 👤 Vartan Ghazarossian
- 👤 Armen B. Shanafelt
- 👤 Carl N. Skold
- 👤 Edwin F. Ullman
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-06 22:23
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; Y10S435/97; Y10S435/971; Y10S435/972; Y10S435/975; Y10S436/00; Y10S436/807; Y10S436/81; Y10S436/815; Y10S436/816; Y10S436/819; Y10S436/822
Claims Analysis
Total Claims: 37
Claim 1
Independent Claim
237 words
A method for conducting an assay for an analyte, which comprises: causing a reagent in a first liquid medium to become non-diffusively bound to a first bibulous member zone in relation to the presence or amount of analyte by contacting said first bibulous member zone with said medium, under conditions wherein said first medium flows through or traverses said first bibulous member zone by capillary action; causing a component in a second liquid medium to be absorbed by a second bibulous member zone in relation to the presence of said analyte in said first medium by contacting a portion of said first bibulous member with said second medium, under conditions wherein said second medium traverses said first bibulous member zone and at least a portion of said second bibulous member zone by capillary action; said second bibulous member zone being of different composition than said first bibulous memebr zone; and determining the distance said component traverses said second bibulous memebr zone to determine the amount of said analyte or determining the presence of said component on at least a portion of said second bibulous member to determine the presence of said analyte with the proviso that when only the presence of said analyte is determined said first bibulous member zone is caused to come into liquid receiving relationship with said second bibulous member zone after said reagent is caused to become bound to said first bibulous member.
Claim 2
Dependent Claim
35 words
The method of Claim 1 wherein said first bibulous member zone and said second bibulous member zone are brought into liquid receiving relationship prior to contacting said first bibulous member zone with said second medium.
Claim 3
Dependent Claim
28 words
The method of Claim 1 wherein a binding partner capable of binding said reagent is non-diffusively bound to at least a portion of said first bibulous member zone.
Claim 4
Dependent Claim
28 words
The method of Claim 1 wherein said component becomes bound to said second bibulous member zone in response to the presence of said analyte in said first medium.
Claim 5
Dependent Claim
28 words
The method of Claim 1 wherein said reagent and said analyte bind together to form a complex and said complex becomes bound to said first bibulous member zone.
Claim 6
Dependent Claim
21 words
The method of Claim 1 wherein a binding partner for said component is non-diffusively bound to said second bibulous member zone.
Claim 7
Dependent Claim
12 words
The method of Claim 1 wherein said analyte is an sbp member.
Claim 8
Independent Claim
191 words
A method for conducting an assay for the determination of a component or a reagent which method comprises: providing in combination a first bibulous member zone ("first zone") and a liquid and a liquid medium containing a component, said first zone having non-diffusively bound thereto a reagent interreactive with said component, under conditions wherein said liquid medium and at least a portion of said component contained therein traverse all of said first zone and migrate by capillary migration into a second bibulous member zone ("second zone"), of different composition than said first zone and incapable of specifically binding said component except when said component is related to the presence or amount of an analyte in which case the method further comprises causing said reagent to become bound to the first zone in relation to the amount of analyte present and determining the distance said component has migrated into said second zone or the difference in the distances said medium and said component having migrated into said second zone, said distance or said difference being related to the amount of said component in said liquid medium or the amount of said reagent.
Claim 9
Dependent Claim
46 words
The method of Claim 8 wherein prior to said combination said reagent is caused to non-diffusively bind to said first zone by contacting said first zone with a solution containing said reagent, and said difference or said distance is related to the amount of said reagent.
Claim 10
Dependent Claim
25 words
The method of Claim 9 wherein said amount of said reagent is related to the amount of an analyte in said solution of said reagent.
Claim 11
Dependent Claim
20 words
The method of Claim 8 wherein said first zone and said second zone are integral to a single bibulous member.
Claim 12
Dependent Claim
50 words
The method of Claim 8 wherein said first zone is integral to a first bibulous member and said second zone is integral to a second bibulous member and said first zone is brought into liquid receiving relationship with said second zone during said assay and prior to providing said combination.
Claim 13
Dependent Claim
20 words
The method of Claim 8 wherein said component and said reagent are each a member of a specific binding pair.
Claim 14
Dependent Claim
21 words
The method of Claim 8 wherein determining the distance said component has migrated into said second zone involves an oxidation-reduction reaction.
Claim 15
Dependent Claim
22 words
The method of Claim 8 wherein said component is an enzyme labelled ligand analog and said reagent is antibody for said ligand.
Claim 16
Dependent Claim
24 words
The method of Claim 8 wherein the difference in the distances said medium and said component have migrated into said second zone is determined.
Claim 17
Dependent Claim
152 words
A method according to Claim 8 for determining the amount of a component or a reagent in a liquid medium which method comprises: contacting a first bibulous member zone ("first zone") with a liquid medium containing a component, said first zone having non-diffusively bound therein a reagent interreactive with said component, under conditions wherein said liquid medium and at least a portion of said component contained therein traverse all of said first zone and migrate by capillary migration into a second bibulous member zone ("second zone") of different composition than said first zone and incapable of specifically binding said component and measuring the distance said component has migrated into said second zone or the different in the distance said medium and said component have migrated into said second zone, said distance or said difference being related to the amount of said component in said liquid medium or the amount of said reagent.
Claim 18
Dependent Claim
144 words
A method according to Claim 1, said method comprising: combining a solution of an analyte with a first bibulous member wherein a reagent capable of reacting with said analyte is or becomes non-diffusively bound to said bibulous member, combining a liquid medium containing a component with said first bibulous member wherein said component is interreactive with said reagent, said first bibulous member being in liquid receiving relationship with or being a portion of a second bibulous member of a composition different from said first bibulous member, under conditions wherein said liquid medium traverses said first bibulous member and at least a portion of said second bibulous member by capillary action, and determining a border on said second bibulous member, the position of said border being related to the amount of analyte in said solution or the amount of reagent on said first bibulous member.
Claim 19
Dependent Claim
230 words
A method according to claim 1, said method comprising: providing in combination in a first liquid medium (1) a first bibulous member and (2) an analyte, wherein a reagent for said analyte is present in said medium or on said first bibulous member, said first bibulous member being in liquid receiving relationship with an absorbent member, under conditions wherein said first medium flows through said first bibulous member and at least a portion of said absorbent member by capillary action and said analyte becomes non-diffusively bound to said bibulous member; terminating the liquid receiving relationship between said bibulous member and said absorbent member; providing in combination in a second liquid medium a portion of said first bibulous member and a component interreactive with said reagent, said first bibulous member being in liquid receiving relationship with a second bibulous member, under conditions wherein said second medium traverses said first bibulous member and at least a portion of said second bibulous member by capillary action, with the proviso that said first bibulous member is in liquid receiving relationship with said absorbent member and said second bibulous member at substantially different times; and determining a border on said second bibulous member, the position of said border being related to the amount of analyte in said first medium or the amount of reagent or the amount of said component in said second liquid medium.
Claim 20
Dependent Claim
278 words
A method according to claim 1, said method comprising: providing in combination in a first liquid medium (1) a first bibulous member, at least a portion thereof having a first reagent non-diffusively bound thereto and (2) a sample suspected of containing an analyte with the proviso that, when said analyte is not capable of binding to said first reagent, a second reagent capable of binding to said analyte and to said first reagent is present in said medium or on said first bibulous member, said first bibulous member being in liquid receiving relationship with an absorbent member, under conditions wherein said first medium traverses said first bibulous member and at least a portion of said absorbent member by capillary action; bringing said first bibulous member into liquid receiving relationship with a second bibulous member; providing in combination in a second aqueous medium a portion of said first bibulous member and a component, said component being capable of binding to said first reagent in relation to the presence of said analyte in said first medium, said second bibulous member having non-diffusively and uniformly bound to at least a portion thereof a specific binding partner for said component, under conditions wherein said second medium traverses at least a portion of said first bibulous member and at least a portion of said second bibulous member by capillary action; and determining the presence of said component on said second bibulous member, the presence thereof being related to the presence of said analyte in said sample or determining the distance of migration of said component on said second bibulous member, the distance being related to the amount of said analyte in said sample.
Claim 21
Dependent Claim
32 words
The method of Claim 20 wherein said liquid receiving relationship between said first bibulous member and said absorbent member is terminated prior to contacting said second bibulous member with said second medium.
Claim 22
Dependent Claim
42 words
The method of Claim 20 wherein said second bibulous member is an immunochromatograph and said component includes an enzyme and said amount of said component bound to said immunochromatographic member is determined by the location on said immunochromatographic member of a border.
Claim 23
Dependent Claim
17 words
The method of Claim 20 wherein said analyte is a drug, preferably wherein said drug is digoxin.
Claim 24
Dependent Claim
24 words
The method of Claim 20 wherein said component is comprised of said analyte bound to a label, preferably wherein said label is an enzyme.
Claim 25
Dependent Claim
16 words
The method of Claim 20 wherein said specific binding partner for said component is an antibody.
Claim 26
Dependent Claim
23 words
The method of Claim 20 wherein said first reagent is an analyte analog, and said second reagent is an antibody for said analyte.
Claim 27
Dependent Claim
28 words
The method of Claim 20 wherein said component is comprised of an antibody for said first reagent bound to a label, preferably wherein said label is an enzyme.
Claim 28
Dependent Claim
269 words
A method according to claim 1, said method comprising: providing in combination in a first aqueous medium (1) a portion of a bibulous member to at least a portion of which is non-diffusively bound a first specific binding pair (sbp) member and (2) a sample suspected of containing an analyte, wherein a conjugate comprising a second sbp member capable of binding said analyte and a third sbp member complementary to said first sbp member is present in said medium or on said bibulous member, said bibulous member being in liquid receiving relationship with an absorbent member, under conditions wherein said first medium traverses said bibulous member and at least a portion of said absorbent member by capillary action and said conjugate becomes non-diffusively bound to said bibulous member; terminating the liquid receiving relationship between said bibulous member and said absorbent member; providing in combination in a second aqueous medium a portion of said bibulous member and a component comprising an analyte analog bound to, or capable of becoming bound to, a member of a signal producing system, said bibulous member being in liquid receiving relationship with an immunochromatographic member having non-diffusively bound thereto a binding partner for said component, under conditions wherein said second medium traverses said bibulous member and at least a portion of said immunochromatographic member by capillary action, with the proviso that said bibulous member is in liquid receiving relationship with said absorbent member and said immunochromatographic member at substantially different times; and determining a border on said immunochromatographic member, the position of said border being related to the amount of analyte in said first medium.
Claim 29
Dependent Claim
17 words
The method of Claim 28 wherein said analyte is a drug, preferably wherein said drug is digoxin.
Claim 30
Dependent Claim
17 words
The method of Claim 28 wherein said conjugate comprises an antibody for said analyte and a protein.
Claim 31
Dependent Claim
276 words
A method according to claim 1, said method comprising: providing in combination in a first aqueous medium (1) a portion of a bibulous member to which is non-diffusively bound an analyte analog and (2) a sample suspected of containing an analyte, wherein a reagent capable of binding said analyte is present in said medium or on said bibulous member, said bibulous member being in liquid receiving relationship with an absorbent member, under conditions wherein said first medium traverses said bibulous member and at least a portion of said absorbent member by capillary action and said reagent becomes non-diffusively bound to said bibulous member in inverse relation to the amount of said analyte in said first medium; terminating the liquid receiving relationship between said bibulous member and said absorbent member; providing in combination in a second aqueous medium a portion of said bibulous member and a component, said component being bound to, or capable of becoming bound to, a member of a signal producing system and being capable of binding to said reagent when said reagent is non-diffusively bound to said bibulous member, said bibulous member being in liquid receiving relationship with an immunochromatographic member having non-diffusively bound thereto a specific binding partner for said component, under conditions under which said second medium traverses said bibulous member and at least a portion of said immunochromatographic member by capillary action, with the proviso that said bibulous member is in liquid receiving relationship with said absorbent member and said immunochromatographic member at substantially different times; and determining a border on said immunochromatographic member, the position of said border being related to the amount of analyte in said first medium.
Claim 32
Dependent Claim
230 words
A method according to claim 1, said method comprising: providing in combination in a first aqueous medium (1) a portion of a bibulous member to which is non-diffusively bound an antibody for said analyte and (2) a sample suspected of containing an analyte, said bibulous member being in liquid receiving relationship with an absorbent member, under conditions wherein said first medium traverses said bibulous member and at least a portion of said absorbent member by capillary action; terminating the liquid receiving relationship between said bibulous member and said absorbent member; providing in combination in a second aqueous medium a portion of said bibulous member and a component, said component being bound to, or capable of becoming bound to, a member of a signal producing system and being capable of binding to said antibody for said analyte, said bibulous member being in liquid receiving relationship with an immunochromatographic member having non-diffusively bound thereto a specific binding partner for said component, under conditions under which said second medium traverses said bibulous member and at least a portion of said immunochromatographic member by capillary action, with the proviso that said bibulous member is in liquid receiving relationship with said absorbent member and said immunochromatographic member at substantially different times; and determining a border on said immunochromatographic member, the position of said border being related to the amount of analyte in said first medium.
Claim 33
Dependent Claim
252 words
A method according to claim 1 for conducting an assay for digoxin, which comprises: contacting an end portion of a bibulous strip having a zone distal from said end portion, said zone having an antibody (Ab₁) for an organic molecule of molecular weight less than 1500 non-diffusively bound thereto with a first aqueous medium containing a sample suspected of containing digoxin, wherein a conjugate comprising an antibody for digoxin bound to said organic molecule is present in said first medium or on said bibulous strip, under conditions wherein said first medium traverses said bibulous strip and at least a portion of said absorbent member by capillary action and said conjugate becomes non-diffusively bound to said Ab₁ and digoxin, if present, becomes bound to said conjugate; terminating the liquid receiving relationship between said bibulous member and said absorbent member; providing in combination in a second aqueous medium said end portion of said bibulous strip and a component comprising a digoxin analog bound to an enzyme, said bibulous strip being in liquid receiving relationship with an immunochromatographic strip having non-diffusively bound thereto an antibody for digoxin, under conditions wherein said second medium traverses said bibulous strip and at least a portion of said immunochromatographic member by capillary action, with the proviso that said strip is in liquid receiving relationship with said absorbent member and said immunochromatographic strip at substantially different times; and determining a border on said immunochromatographic strip, the position of said border being related to the amount of analyte in said sample.
Claim 34
Independent Claim
139 words
A device for analyzing for the presence of an analyte, which device comprises: (a) a first bibulous member, at least a portion thereof having a first member of a specific binding pair capable of binding said analyte or a reagent in relation to said analyte, (b) an absorbent member in terminable liquid receiving relationship with said first bibulous member, (c) a second bibulous member, at least a portion thereof having bound thereto a second member of a specific binding pair capable of binding said analyte or said reagent, said second bibulous member being adapted to establish a liquid receiving relationship with said first bibulous member, and (d) means for terminating the liquid receiving relationship between said first bibulous member and said absorbent member and establishing a liquid receiving relationship between said first bibulous member and said second bibulous member.
Claim 35
Dependent Claim
14 words
A device according to Claim 34 wherein said second bibulous member is an immunochromatograph.
Claim 36
Dependent Claim
25 words
A kit for conducting an assay, which comprises in packaged combination the device with the reagents for conducting an assay of Claim 34 or 35.
Claim 37
Independent Claim
198 words
A method for conducting an assay for an analyte, which comprises: causing a specific binding pair (sbp) member in a first aqueous medium to become bound to a first bibulous member by contacting a portion of said first bibulous member with said medium, said first bibulous member being in liquid receiving relationship with an absorbent member, under conditions wherein said first medium traverses said first bibulous member and at least a portion of said absorbent member by capillary action; causing said first bibulous member to come into liquid receiving relationship with a second bibulous member; causing a component in a second aqueous medium to be absorbed by said second bibulous member in relation to the presence of said analyte in said first medium by contacting a portion of said first bibulous member with said second aqueous medium, under conditions wherein said second aqueous medium traverses said first bibulous member by capillary action and at least a portion of said second bibulous member; said portion of said second bibulous member being of different composition than said portion of said first bibulous member; and determining the presence of said component on at least a portion of said second bibulous member.
References Cited (Backward Citations)
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