EP0560411A2
Expired / Lapsed
EP
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A test device for performing specific binding assays
Assignee: Alere Switzerland GmbH
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Filing: 1988-04-26
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Granted: —
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Expires: 2008-04-26
Abstract
Abstract An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture (508) in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.
Inventors
- 👤 Keith May
- 👤 Michael Evans Prior
- 👤 Ian Richards
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-07 07:54
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54388; G01N33/544; G01N33/548; G01N33/549; G01N33/58; G01N33/68; G01N33/689; G01N33/74; G01N33/76; G01N2800/00; G01N2800/36; G01N2800/368; G01N30/00; G01N30/90; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/81; Y10S435/962; Y10S435/969; Y10S435/97; Y10S435/975; Y10S436/00; Y10S436/805; Y10S436/807; Y10S436/81; Y10S436/811; Y10S436/814; Y10S436/815; Y10S436/817; Y10S436/818; Y10S436/906
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
164 words
An analytical test device, characterised in that it comprises a hollow casing (500) constructed of moisture-impervious solid material containing a dry porous carrier (510) which communicates directly or indirectly with the exterior of the casing such that a liquid test sample can be applied to the porous carrier, the device also containing a labelled specific binding reagent for an analyte which labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised in a detection zone on the carrier material and is therefore not mobile in the moist state, the relative positioning of the labelled reagent and detection zone being such that liquid sample applied to the device can pick up labelled reagent and thereafter permeate into the detection zone, and the device incorporating means enabling the extent (if any) to which the labelled reagent becomes bound in the detection zone to be observed.
Claim 2
Dependent Claim
166 words
An analytical test device, characterised in that it comprises a hollow casing (500) constructed of moisture-impervious solid material containing a dry porous carrier (510) which communicates directly or indirectly with the exterior of the casing such that a liquid test sample can be applied to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent for an analyte, which labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed.
Claim 3
Dependent Claim
25 words
A test device according to claim 1 or claim 2, characterised in that the label on the first specific binding reagent is a direct label.
Claim 4
Dependent Claim
41 words
A test device according to any one of claims 1 to 3, characterised in that the casing is constructed of opaque or translucent material, and is provided with at least one aperture (508) through which the analytical result may be observed.
Claim 5
Dependent Claim
56 words
A test device according to any one of the preceding claims, characterised in that the porous carrier (510) communicates with the exterior of the device via a bibulous sample receiving member (506) which protrudes from the casing and which can act as a reservoir to receive the liquid sample and release it into the porous carrier.
Claim 6
Dependent Claim
27 words
A test device according to claim 5, characterised in that it incorporates a removable and replaceable moisture-impervious cover (503) for the protruding bibulous sample receiving member (506).
Claim 7
Dependent Claim
25 words
A test device according to any one of the preceding claims, characterised in that the casing, and cover if present, is moulded from plastics material.
Claim 8
Dependent Claim
57 words
A test device according to any one of the preceding claims, characterised in that the porous carrier comprises a strip or sheet of porous material (510) backed with a layer (511) of transparent moisture-impervious material, the transparent layer being in contact with the inside of the casing adjacent the aperture(s) to inhibit ingress of moisture or sample.
Claim 9
Dependent Claim
27 words
A test device according to claim 7, characterised in that the porous carrier material is nitrocellulose, preferably having a pore size of greater than about 1 micron.
Claim 10
Dependent Claim
31 words
A test device according to any one of the preceding claims, characterised in that the label comprises coloured latex particles having a maximum dimension of not greater than about 0.5 micron.
Claim 11
Dependent Claim
50 words
A test device according to any one of the preceding claims, characterised in that it incorporates a control zone downstream from the second zone in the porous carrier to indicate that the liquid sample has permeated beyond the second zone, the control zone also being observable from outside the casing.
Claim 12
Dependent Claim
192 words
A pregnancy testing device, characterised in that it comprises a hollow elongated casing containing a dry porous nitrocellulose carrier which communicates indirectly with the exterior of the casing via a bibulous urine receiving member which protrudes from the casing and which can act as a reservoir from which urine is released into the porous carrier, the carrier containing in a first zone a highly-specific anti-hCG antibody bearing a coloured "direct" label, the labelled antibody being freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone an highly-specific unlabelled anti-hCG antibody which is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the labelled and unlabelled antibodies having specificities for different hCG epitopes, the two zones being arranged such that a urine sample applied to the porous carrier can permeate via the first zone into the second zone, and the casing being constructed of opaque or translucent material incorporating at least one aperture through which the analytical result may be observed, together with a removable and replaceable cover for the protruding bibulous urine receiving member.
Claim 13
Dependent Claim
21 words
A fertile period prediction device, having all the features of the device of claim 12 except that the analyte is LH.
Claim 14
Dependent Claim
45 words
A dry porous carrier for use in a specific binding assay, comprising a strip or sheet of nitrocellulose having a pore size of at least about 1 micron, preferably about 8-12 microns, carrying in a zone thereof an immobilised specific binding reagent for an analyte.
Claim 15
Dependent Claim
20 words
A carrier according to claim 14 which is backed by a layer of solid water-impervious material, preferably transparent plastics material.
Claim 16
Dependent Claim
37 words
A carrier according to claim 15 carrying in another zone thereof a labelled specific binding reagent for the same analyte, which labelled specific binding reagent is freely mobile within the carrier material when in the moist state.
Claim 17
Dependent Claim
29 words
A carrier according to claim 16, wherein the label is a direct label, preferably a coloured latex particle having a maximum dimension of not greater than about 0.5 micron.
Claim 18
Dependent Claim
34 words
A carrier according to claim 17, wherein the zone carrying the labelled reagent has been pre treated with a glazing material, such as a sugar, prior to the application of the labelled reagent thereto.
Claim 19
Dependent Claim
50 words
A specific binding assay involving the use of a labelled reagent which is free to migrate through a porous carrier material moistened by the application thereto a of an aqueous sample suspected of containing an analyte, characterised in that the label is a direct label, preferably a coloured latex particle.
References Cited (Backward Citations)
EP0291194B1
Cited
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