초록 ▼

The present invention relates to an enzyme reagent ticket for conducting diagnostic or serological tests. More particularly, the present invention relates to an enzyme reagent device which allows for a low-cost, disposable, rapid and convenient system for use in the determination of various componen

The present invention relates to an enzyme reagent ticket for conducting diagnostic or serological tests. More particularly, the present invention relates to an enzyme reagent device which allows for a low-cost, disposable, rapid and convenient system for use in the determination of various components in test fluids, and to a diagnostic kit including the device according to the present invention for conducting certain immunochemical, diagnostic or serological testing.

대표청구항 ▼

An enzyme immunoassay device for use in determining the presence of an analyte in a sample which comprises: i) a planar support comprising an upper surface and a lower surface and further comprising a fold means defining a first and a second support half by which the upper surface of the device may

An enzyme immunoassay device for use in determining the presence of an analyte in a sample which comprises: i) a planar support comprising an upper surface and a lower surface and further comprising a fold means defining a first and a second support half by which the upper surface of the device may be folded together along said means; ii) a first opening in the first support half (a) spaced a defined distance from the fold means, (b) extending through the support, and (c) defining a sample well comprising an interior being opened at the lower surface of the support and closed at the upper surface of the support with a closure comprising a conjugate pad of negligible liquid absorptive qualities facing the interior of the sample well, said conjugate pad containing a mobilizable immunoreactant comprising said analyte conjugated to an enzyme; and an antibody pad having greater liquid absorptivity than said conjugate pad, comprising an immobilized antibody that specifically binds to said analyte, and located axial to the conjugate pad and at the upper surface of the support: and iii) a second opening located at the upper surface of the second support half (a) spaced an equal distance to the first opening from the fold means, (b) extending partially through the support, and (c) containing a readout pad comprising a chromophoric indicator means that reacts with said enzyme to produce a color change, and wherein the antibody and readout pads will be in contact with each other when the support is folded along the fold means. A method for utilizing an enzyme immunoassay device for determining the presence of an analyte in a liquid sample which comprises: i) providing said sample; ii) providing a device according to claim 1 wherein the conjugate pad is a disk of fibers with negligible absorptive properties, the immunoreactant comprises the analyte conjugated to a first enzyme, the antibody pad is a disk containing the immobilized antibody, and the readout pad is a disk containing the chromophoric indicator; iii) adding the sample to the conjugate disk; iv) allowing said sample to flow through the conjugate disk to mobilize and to transport the immunoreactant into the antibody disk wherein both said immunoreactant and the analyte in said liquid sample are competitively bound by said immobilized antibody; v) folding said device along said fold means; vi) expressing said sample from the antibody disk into the readout disk wherein said chromophoric indicator, comprising a substrate for said first enzyme and second enzyme that reacts with a product produced by said first enzyme to yield a change in color, reacts with said first enzyme in any immunoreactant not bound by said immobilized antibody; and vii) noting the presence of any change in the color of the indicator which change indicates the presence of said analyte in said sample.