Integrated packaging-holder device for immunochromatographic assays in flow-through or dipstick formats
First Claim
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1. An immunochromatographic assay device comprising:
- a) means for conducting an immunochromatographic assay to detect the presence of an analyte in a sample, which assay means define a detection zone; and
b) means for sealing the assay means in a substantially air-tight and a substantially fluid-tight manner, said sealing means contacting and supporting said assay means wherein said assay means is laminated within said sealing means, and said sealing means being adapted to expose the assay means to a liquid sample;
wherein said assay means sealed in said sealing means behaves as a hydrogel.
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Abstract
The present invention relates to an integrated package-holder assay devices for detecting the presence of analyte in a sample. The device serves the dual roles of supporting and protecting an immunochromatographic assay. The device is compatible with any immunochromatographic assay format. The assay can be performed in a single apparatus for use in a laboratory or a field setting. In a specific example, the assay device is a nylon membrane formatted for an immunochromatographic assay for continue sealed between transparent adhesive tape and a stiff plastic strip. White tape placed over the plastic strip defined a window for observing the assay results.
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Citations
27 Claims
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1. An immunochromatographic assay device comprising:
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a) means for conducting an immunochromatographic assay to detect the presence of an analyte in a sample, which assay means define a detection zone; and b) means for sealing the assay means in a substantially air-tight and a substantially fluid-tight manner, said sealing means contacting and supporting said assay means wherein said assay means is laminated within said sealing means, and said sealing means being adapted to expose the assay means to a liquid sample; wherein said assay means sealed in said sealing means behaves as a hydrogel. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An immunochromatographic assay device, comprising:
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a) a first elongated substantially non-wettable layer; b) a strip member capable of conveying a liquid sample therethrough and containing assay reagents and a detection zone for detecting the presence of an analyte in a sample, said strip member being mounted on said first layer; and c) second elongated substantially non-wettable layer mounted over said first layer and strip member, said second layer being sealed to the first layer around the strip member, whereby said strip member is laminated between said first and second elongated substantially non-wettable layers; wherein at least one of said first and second layers defines a transparent window aligned with the assay reagents for observing the assay result, and said first and second layers are adapted to expose said strip member to the sample; and
wherein said strip member mounted between said first and second elongated substantially non-wettable layers behaves as a hydrogel. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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25. A method for conducting an assay to determine the presence of an analyte in a sample, comprising:
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a) exposing a portion of a membrane strip that behaves as a hydrogel, which membrane strip contains means for conducting an immunochromatographic assay, which assay means includes a detection zone, wherein said membrane strip is laminated between at least two substantially non-wettable layers having at least one transparent window portion aligned with the detection zone; b) applying the sample to the exposed portion of the membrane strip, whereby the sample is conveyed by the membrane strip to the detection zone; and c) observing an assay result in the detection zone through the window portion; wherein the assay result corresponds to the presence of the analyte in the sample.
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26. A method for conducting an assay to determine the presence of an analyte in a sample, comprising:
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a) exposing a portion of the assay means of an immunochromatographic assay device comprising; i) means for conducting an immunochromatographic assay to detect the presence of an analyte in a sample, which assay means define a detection zone; and ii) means for sealing the assay means in a substantially air-tight and a substantially fluid-tight manner, said sealing means contacting and supporting said assay means wherein said assay means is laminated within said sealing means, and said scaling means being adapted to expose a portion of the assay means to a liquid sample;
wherein said assay means sealed in said sealing means behaves as a hydrogel;b) applying a sample to the exposed portion of the assay means, whereby the sample is conveyed by the assay means to the detection zone; and c) observing an assay result in the detection zone; wherein the assay result corresponds to the presence of the analyte in the sample.
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27. A method for conducting an assay to determine the presence of an analyte in a sample, comprising:
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a) exposing a portion of an strip member of an immunochromatographic assay device, comprising; i) a first elongated substantially non-wettable layer; ii) a strip member capable of conveying a liquid sample therethrough and containing assay reagents and a detection zone for detecting the presence of an analyte in a sample, said strip member being mounted on said first layer; and iii) a second elongated substantially non-wettable layer mounted over said first layer and strip member, said second layer being sealed in a substantially air-tight and a substantially fluid-tight manner to the first layer around the strip member, whereby said strip member is laminated between said first and second elongated substantially non-wettable layers;
wherein at least one of said first and second layers defines a transparent window aligned with the assay reagents for observing the assay result, and said first and second layers are adapted to expose said strip member to the sample, and wherein said strip member mounted between said first and second elongated substantially non-wettable layers behaves as a hydrogel;b) applying the sample to the exposed portion of the strip member, whereby the sample is conveyed by the strip member w the detection zone; and c) observing an assay result in the detection zone through the window portion; wherein the assay result corresponds to the presence of the analyte in the sample.
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Specification