Integrated packaging-holder device for immunochromatographic assays in flow-through or dipstick formats

Claim 2

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.

Claim 3

The device according to claim 1, in which the sealing means is adapted to be opened by cutting the sealing means.

Claim 4

The device according to claim 1, wherein said sealing means defines a transparent window aligned with said test zone for viewing the assay results.

Claim 5

The device according to claim 1, further comprising stiffener means joined to said sealing means for stiffening said device.

Claim 6

The device according to claim 4, wherein said sealing means and said stiffener means are substantially transparent and said device further comprises a substantially non-transparent layer joined to said stiffener means to define a widow for viewing said test zone through said stiffener means and sealing means.

Claim 7

The device according to claim 1, further comprising means for detecting contamination within said sealing means.

Claim 8

The device according to claim 1, further comprising a container for holding a sample to be assayed, wherein said sealing means and assay means are secured to an interior surface of said container.

Claim 9

The device according to claim 7, wherein said sealing means is provided with means for exposing said assay means.

Claim 10

The device of claim 4 in which the stiffening means is transparent plastic.

Claim 11

The device of claim 1 which comprises assay means for more than one analyte.

Claim 12

The device of claim 1 in which the sealing means is transparent plastic tape.

Claim 13

The device of claim 1 in which the assay means comprises a material selected from the group consisting of a membrane, coated plastic, coated glass, a filter, silica gel, paper, agarose gel, polyacrylamide gel, and gelatin.

Claim 14

The device of claim 1 in which the assay means comprises a nylon membrane.

Claim 15

The device of claim 1 in which the immunochromatographic assay means are attached to the sealing means by an adhesive.

Claim 16

The device of claim 14 in which the adhesive is selected from the group consisting of double-sided tape and an adhesive on the sealing means.

Claim 17

The device of claim 4 in which the stiffening means are sealed to the sealing means by a sonic weld, double-sided adhesive tape, or an adhesive.

Claim 18

The device of claim 1 in which the immunochromatographic assay means comprises a zone for positively detecting the presence of an analyte in a sample in a competitive immunochromatographic assay on an assay strip, in which the immunochromatographic assay includes a mobilizable reagent conjugated to a label such that in the presence of a liquid sample the labeled reagent is transported with the sample along the assay strip to a detection zone, which detection zone is a region of the assay strip comprising the label immobilized in an area thereof and a specific binding partner of the labeled reagent immobilized in an area thereof adjacent to and separate from the area to which the label has been immobilized, whereby a contrast can be observed between the area to which the label has immobilized and the area to which the specific binding partner has been immobilized, such that upon mobilization of the labeled reagent in the absence of analyte, the labeled reagent binds to the immobilized specific binding partner in the detection zone so as to abolish the contrast between the, immobilized label and the immobilized specific binding partner, and upon mobilization of the labeled reagent in the presence of analyte, the labeled reagent does not bind to the immobilized specific binding partner in the detection zone due to binding of the analyte to the specific binding partner in the detection zone so as to preserve the contrast between the label and the membrane strip in the detection zone, wherein a contrasting signal in the detection zone indicates the presence of analyte in the sample and a non-contrasting signal in the detection zone indicates the absence of analytic in the sample.

Claim 19

An immunochromatographic assay device, comprising: 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.

Claim 20

An immunochromatographic assay device, comprising: 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.

Claim 21

The device of claim 18 in which the first or second layer is transparent plastic.

Claim 22

The device of claim 18 in which the second layer is sealed to the first layer with transparent plastic tape or a sonic weld.

Claim 23

The device of claim 18 in which the strip member is a nylon membrane.

Claim 24

The device of claim 18 in which the strip member is attached to the first layer by double-sided adhesive tape.

Claim 25

The device of claim 18 which comprises more than one strip member, whereby more than one analyte can be detected in a sample.

Claim 26

The device of claim 18 in which the membrane strip comprises a zone for positively detecting the presence of an analyte in a sample in a competitive immunochromatographic assay on an assay strip, in which the immunochromatographic assay includes a mobilized reagent conjugated to a label such that in the presence of a liquid sample the labeled reagent is transported with the sample along the assay strip to a detection zone, which detection zone is a region of the assay strip comprising the label immobilized in an area thereof and a specific binding partner of the labeled reagent immobilized in an area thereof adjacent to and separate from the area to which the label has been immobilized, whereby a contrast can be observed between the area to which the label has been immobilized and the area to which the specific binding partner has been immobilized, such that upon mobilization of the labeled reagent in the absence of analyte, the labeled reagent binds to the immobilized specific binding partner in the detection zone so as to abolish the contrast between the immobilized label and the immobilized specific binding partner and upon mobilization of the labeled reagent in the presence of analyte, the labeled reagent does not bind to the immobilized specific binding partner in the detection zone due to binding of the analyte to the specific binding partner in the detection zone so as to preserve the contrast between the label and the membrane strip in the detection zone, wherein a contrasting signal in the detection zone indicates the presence of analyte in the sample and a non-contrasting signal in the detection zone indicates the absence of analyte in the sample.