Diagnostic assay device

Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter

Reexamination Certificate

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C422S067000, C436S165000, C436S169000

Reexamination Certificate

active

06432358

ABSTRACT:

This application is directed to a diagnostic assay device and, more particularly, to a diagnostic assay device which allows retention of a fluid test sample applied to the assay device until it is desired to carry out its interaction with the test materials utilized to provide a detectable change.
BACKGROUND OF THE INVENTION
Devices for use in diagnostic assays are known in the art, including devices which provide a luminescence readout signal as an indication of whether a particular analyte or metabolite is present in a test fluid. U.S. Pat. No. 3,390,962 discloses a biochemical test plate for the facile determination of the immunoprecipitation titer of an antigen-antibody reaction and for determining the antigenic similarities between several antigens when each is at its optimum concentration for the precipitin reaction. In operation, a constant concentration of antibody is disposed in troughs and serially diluted serum or antigen is placed individually into the cup-shaped depressions of the apertures, thereby measuring the immunodiffusion precipitin reaction over a concentration range.
U.S. Pat. No. 3,415,361 discloses a disposable test device and container therefor. The test device described therein includes a container in which pre-measured quantities of reactants for a chemical or immunological test are stored ready for use, with the container being adapted to provide a reaction vessel for the test and to permit observation of visible changes indicating the occurrence of and/or the extent of the reaction caused by the introduction thereinto of an aliquot sample of fluid to be tested, whereby tests can be carried out with a minimum of manipulative steps and supportive equipment.
U.S. Pat. No. 3,865,548 discloses an analytical apparatus for performing chemical analysis and, in particular, to small load operation biomedical test needs. The apparatus described therein comprises a cuvette having therein a first porous barrier which serves to compartmentalize the cuvette, and a first test reagent fluid in a first reagent compartment in the cuvette, the barrier being in direct contact therewith, a second porous barrier and a second test reagent fluid being present, the second test reagent being disposed in a second compartment on the side of the second barrier away from the first reagent compartment, the second barrier being in direct contact with the second test reagents.
U.S. Pat. No. 4,264,560 discloses a clinical analytical system which includes an arrangement for the chemical analysis of a small quantity of sample wherein a specimen of small size is passed through a porous distribution first medium onto a reagent-containing second medium. The reagent-containing second medium is a thin, flat, liquid-impervious medium. A reagent is encapsulated upon the second medium as a flat, liquid-phase surface. The first and second mediums are so arranged and disposed that when firmly pressed together, the encapsulated liquid reagent will be liberated and the specimen will be distributed through the first medium onto the liquid-phase liberated reagent where the subsequent reaction of the liquid-phase reagent and the specimen can then be identified by reading means.
U.S. Pat. No. 4,510,393 discloses a self-contained, portable photo chamber for photographically recording the extent of a chemical reaction such as in an immunological test, wherein a substrate emitting radiation such as gamma radiation is supported in facing contact with a film and with intensifying means, so that exposure time is reduced as a result of emission of further radiation such as a visible light from the intensifying means and its recording on the film.
U.S. Pat. No. 4,587,221 discloses a non-centrifugation
on-decantation method for carrying out specific binding assay tests, wherein liquid and solid phases are present. The device described therein consists of a mixing reservoir into which is fitted snugly a mixing separator having a channel in the vertical axis of the mixer separator. A rack holding a number of the mixing reservoirs containing the incubated reagents and analytes, capped with the mixer separators, is placed into a press-device designed to perform at a controlled rate a downward movement. The mixer separators are pushed downwards into the mixing reservoirs at a chosen rate for a preselected distance to complete the mass transport and separation operations. The separation devices are removed and either one of the separated phases can be measured in the desired analytical instrument for a quantitative or qualitative determination.
U.S. Pat. No. 4,797,259 discloses a diagnostic test device which includes a plate having at least one well, preferably a plurality of wells, each with an open bottom across which a composite membrane comprising three layers is placed, with a hydrophobic, liquid-tight seal provided at the periphery of the each well. The composite membrane from the top of the upstream side to the bottom or downstream side, in sequence, includes a first reaction or filtration layer formed from a thin, lipophilic, microporous membrane, a second or sealing layer, preferably a hydrophobic material in sheet or fiber form, such as nonwoven polypropylene fibers, and a liquophobic, preferably hydrophobic, barrier layer having one or more apertures which allows liquid to exit the well while eliminating lateral migration of a pendant liquid drop. The liquophobic seal provided by the liquophobic sealing layer eliminates “cross-talk” by lateral diffusion or wicking.
U.S. Pat. No. 5,035,866 discloses an apparatus for performing and measuring chemical reactions which includes a reaction test apparatus having reaction wells wherein reactants are controllably mixed, and exposure apparatus which receives and positions the reaction test apparatus adjacent a photographic film. Each of the reaction wells includes at least two reaction cups, arranged one above the other. The uppermost reaction cups have orifices in the bottoms, so that the liquid can be mixed and reacted in the uppermost cup, and then controllably transferred to the lower cup to be mixed with additional reactants. In a preferred embodiment, the reaction cups are supported in plates that are structurally integral with the cups, and are superimposed to make a test block. The test block is retained in the exposure apparatus, and liquid is forced from the upper cup to the lower cup by application of pressure to the top of the upper cup.
U.S. Pat. No. 5,418,171 discloses an apparatus for determining the presence or absence of a target analyte in a liquid sample, which comprises: a container capable of accommodating the liquid sample and having a transparent portion; and an insertion member which is capable of being inserted into the container and which comprises: a porous member which has a main surface and a reverse surface and which has on the main surface a substance capable of specifically binding to the target analyte; and an absorbent bonded to the reverse surface of the porous member; the porous member being supported in the insertion member whereby, when the insertion member is inserted into the container, the main surface can be observed from the outside of the container through the transparent portion of the vessel and the liquid sample is absorbed into the absorbent through the porous member.
U.S. Pat. No. 5,552,276 discloses a measuring apparatus for use in a binding assay to determine the presence or amount of an analyte in a fluid test sample through the use of a label capable of producing a detectable response, which comprises: a porous body having releasably attached thereto an agent soluble in the test sample; a liquid permeable porous reaction membrane disposed below the porous body having defined thereon at least one reaction area, the reaction area having immobilized thereon an affinity substance capable of directly or indirectly capturing the analyte or an agent soluble in the test sample to thereby produce the detectable response; an absorption member disposed below the liquid permeable porous membrane having an opening being po

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