Assays
DCFirst Claim
1. An analytical test device for detecting an analyte suspected of being present in a liquid biological sample, said device comprising:
- a) a hollow casing having a first end, a second end, a longitudinal axis, and a liquid biological sample application aperture adjacent to said first end;
b) a displaceable shroud disposed on said first end for shielding said liquid biological sample application aperture;
c) a test strip comprising a dry porous carrier disposed within said hollow casing, said dry porous carrier communicating directly or indirectly with the exterior of said hollow casing through said liquid biological sample application aperture to receive applied said liquid biological sample;
said dry porous carrier having a detection zone;
said hollow casing including means permitting observation of said detection zone from outside said casing;
said test strip, in the dry unused state, containing upstream from said detection zone a labelled reagent capable of specifically binding with said analyte to form a first complex of said labelled reagent and said analyte, said labelled reagent being labelled with a particulate direct label, wherein said labelled reagent is dry on said test strip prior to use and is released into mobile form by said liquid biological sample,wherein mobility of said labelled reagent within said test strip is facilitated by at least one of
1) coating at least a portion of said test strip upstream from said detection zone with, or
2) drying said labelled reagent onto a portion of said test strip upstream of said detection zone in the presence of, a material comprising sugar, in an amount effective to reduce interaction between said test strip and said labelled reagent;
said dry porous carrier containing in said detection zone a means for binding said first complex, said means for binding comprising specific binding means and being immobilized in said detection zone;
migration of said liquid biological sample through said dry porous carrier conveying by capillarity said first complex to said detection zone of said dry porous carrier whereat said binding means binds said first complex thereby to form a second complex;
said second complex being observable via said detection zone observation means, thereby to indicate the presence of said analyte in said liquid biological sample.
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Accused Products
Abstract
An analytical test device useful for example in pregnancy testing, includes 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, wherein the mobility is facilitated by a material comprising sugar, in a amount effective to reduce interaction between the test strip and the labelled reagent, and in a second zone spatially distinct from the first zone unlabeled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilized 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 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.
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Citations
34 Claims
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1. An analytical test device for detecting an analyte suspected of being present in a liquid biological sample, said device comprising:
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a) a hollow casing having a first end, a second end, a longitudinal axis, and a liquid biological sample application aperture adjacent to said first end; b) a displaceable shroud disposed on said first end for shielding said liquid biological sample application aperture; c) a test strip comprising a dry porous carrier disposed within said hollow casing, said dry porous carrier communicating directly or indirectly with the exterior of said hollow casing through said liquid biological sample application aperture to receive applied said liquid biological sample;
said dry porous carrier having a detection zone;
said hollow casing including means permitting observation of said detection zone from outside said casing;
said test strip, in the dry unused state, containing upstream from said detection zone a labelled reagent capable of specifically binding with said analyte to form a first complex of said labelled reagent and said analyte, said labelled reagent being labelled with a particulate direct label, wherein said labelled reagent is dry on said test strip prior to use and is released into mobile form by said liquid biological sample,wherein mobility of said labelled reagent within said test strip is facilitated by at least one of
1) coating at least a portion of said test strip upstream from said detection zone with, or
2) drying said labelled reagent onto a portion of said test strip upstream of said detection zone in the presence of, a material comprising sugar, in an amount effective to reduce interaction between said test strip and said labelled reagent;said dry porous carrier containing in said detection zone a means for binding said first complex, said means for binding comprising specific binding means and being immobilized in said detection zone; migration of said liquid biological sample through said dry porous carrier conveying by capillarity said first complex to said detection zone of said dry porous carrier whereat said binding means binds said first complex thereby to form a second complex; said second complex being observable via said detection zone observation means, thereby to indicate the presence of said analyte in said liquid biological sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A kit comprising a packaged pregnancy test device for detecting hCG suspected of being present in a urine sample, said device comprising:
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a) a hollow casing having a first end, a second end, a longitudinal axis, and a urine sample application aperture adjacent to said first end; b) a displaceable shroud disposed on said first end for shielding said urine sample application aperture; c) a test strip comprising a dry porous carrier disposed within said hollow casing, wherein said dry porous carrier is nitrocellulose and communicates indirectly with the exterior of said hollow casing via a bibulous urine sample receiving member which protrudes from said hollow casing and which acts as a reservoir from which said urine sample is released into said dry porous carrier, said dry porous carrier having a detection zone;
said hollow casing including means permitting observation of said detection zone from outside said casing;said dry porous carrier containing in a first zone upstream from said detection zone a labelled reagent comprising a colored particulate direct label conjugated to an anti-hCG antibody, wherein said anti-hCG antibody present in said labelled reagent is capable of specifically binding with said hCG to form a first complex of said labelled reagent and said hCG, wherein said labelled reagent is dry on said test strip prior to use and is released into mobile form by said urine sample, said labelled reagent being freely mobile within said test strip when said test strip is wetted with said urine sample, said detection zone being spatially distinct from said first zone; wherein mobility of said labelled reagent within said test strip is facilitated by at least one of
1) coating at least said first zone with, or
2) drying said labelled reagent onto a portion of said first zone in the presence of, a material comprising sugar, in an amount effective to reduce interaction between said test strip and said labelled reagent;said dry porous carrier containing in said detection zone a means for specifically binding said first complex, said means for specifically binding said first complex being an unlabelled anti-hCG antibody which is impregnated throughout the thickness of said dry porous carrier in said detection zone and is permanently immobilized in said detection zone, wherein said anti-hCG antibody of said labelled reagent and said unlabelled anti-hCG antibody specifically bind to different hCG epitopes, said first zone and said detection zone being arranged such that said urine sample applied to said protruding bibulous urine sample receiving member and consequently to said dry porous carrier can migrate via said first zone into said detection zone, said migration of said urine sample through said dry porous carrier conveying by capillarity said first complex to said detection zone whereat said means for specifically binding binds said first complex thereby to form a second complex; said second complex being observable via said means permitting observation in said detection zone, thereby to indicate the presence of said hCG in said urine sample.
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34. A kit comprising a packaged fertile period prediction test device for detecting LH suspected of being present in a urine sample, said device comprising:
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a) a hollow casing having a first end, a second end, a longitudinal axis, and a urine sample application aperture adjacent to said first end; b) a displaceable shroud disposed on said first end for shielding said urine sample application aperture; c) a test strip comprising a dry porous carrier disposed within said hollow casing, wherein said dry porous carrier is nitrocellulose communicates indirectly with the exterior of said hollow casing via a bibulous urine sample receiving member which protrudes from said hollow casing and which acts as a reservoir from which said urine sample is released into said dry porous carrier, said dry porous carrier having a detection zone;
said hollow casing including means permitting observation of said detection zone from outside said casing;said dry porous carrier containing in a first zone upstream from said detection zone a labelled reagent comprising a colored particulate direct label conjugated to an anti-LH antibody, wherein said anti-LH antibody present in said labelled reagent is capable of specifically binding with said LH to form a first complex of said labelled reagent and said LH, wherein said labelled reagent is dry on said test strip prior to use and is released into mobile form by said urine sample, said labelled reagent being freely mobile within said test strip when said test strip is wetted with said urine sample, said detection zone being spatially distinct from said first zone; wherein mobility of said labelled reagent within said test strip is facilitated by at least one of
1) coating at least said first zone with, or
2) drying said labelled reagent onto a portion of said first zone in the presence of, a material comprising sugar, in an amount effective to reduce interaction between said test strip and said labelled reagent;said dry porous carrier containing in said detection zone a means for specifically binding said first complex, said means for specifically binding said first complex being an unlabelled anti-LH antibody which is impregnated throughout the thickness of said dry porous carrier in said detection zone and is permanently immobilized in said detection zone. wherein said anti-LH antibody of said labelled reagent and said unlabelled anti-LH antibody specifically bind to different LH epitopes, said first zone and said detection zone being arranged such that said urine sample applied to said protruding bibulous urine sample receiving member and consequently to said dry porous carrier can migrate via said first zone into said detection zone, said migration of said urine sample through said dry porous carrier conveying by capillarity said first complex to said detection zone whereat said means for specifically binding binds said first complex thereby to form a second complex; said second complex being observable via said means permitting observation in said detection zone, thereby to indicate the presence of said LH in said urine sample.
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Specification