Chemistry: analytical and immunological testing – Involving diffusion or migration of antigen or antibody
Reexamination Certificate
1999-11-01
2003-08-12
Chin, Christopher L. (Department: 1641)
Chemistry: analytical and immunological testing
Involving diffusion or migration of antigen or antibody
C422S051000, C422S051000, C422S051000, C422S051000, C422S067000, C435S287100, C435S287200, C435S287700, C435S287900, C435S805000, C435S810000, C435S970000, C435S975000, C436S169000, C436S518000, C436S809000, C436S810000
Reexamination Certificate
active
06605476
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to chromatography immunoassay devices in which chromatography strips are used. More particularly, the invention relates to a chromatography immunoassay device in which one or more chromatography strips are located on a substrate, each of the chromatography strips is sealed between the substrate and a seal film that entirely covers the chromatography strips, and the seal film and/or substrate is possessed of a film containing a dehumidifying agent and/or a film containing an oxygen absorbing agent.
BACKGROUND OF THE INVENTION
Chromatography immunoassay devices, in which chromatography strips are used, are devices which immunologically detect or measure the presence or quantity of substances to be assayed that are contained in samples, the device having at least a sample adding means and a detecting means. In some cases the chromatography strip also has a labeling means, and such a device is well known and broadly used, as disclosed for example in JP-A-61-145459 (the term “JP-A” as used herein means an “unexamined, published Japanese patent application”), JP-A-1-63865 and JP-W-1-503174 (the term “JP-W” as used herein means an “unexamined, published Japanese international patent application”), all incorporated herein by reference.
Each chromatography strip must be protected by appropriate means, such as packaging, in order to prevent antibodies and like reagents in the chromatography strip from degeneration caused by oxygen, moisture and the like, and to protect the strip itself from pollution caused by touching, or from deformation and the like. Protection by packaging or the like means is effected generally by sticking or putting one or a plurality of chromatography strips on a substrate, putting the resulting preparation into a protective case and then sealing the case in a bag. Alternatively, each chromatography strip is sealed with a laminate film as disclosed in WO 94/24563, incorporated herein by reference. When packed in a bag, the chromatography strip is sealed together with a dehumidifying agent in order to minimize moisture absorption by the chromatography strip.
In the conventional chromatography immunoassay device, however, each chromatography strip requires a protective case, a dehumidifying agent and a package where one chromatography strip is sealed, thus costing much for packaging. In a case in which a plurality of chromatography strips are stuck on a substrate, all of the chromatography strips are packed in a single bag together with a necessary amount of a dehumidifying agent and sealed with a packaging material which is substantially water impermeable. Though this method can reduce the cost required for the packaging material and dehumidifying agent, unsealing the bag to use a first chromatography strip causes exposure of other chromatography strips to the air, or moisture and oxygen, thus posing a problem of causing their deterioration. Thus, it is necessary to take special protective and storage measures, because the stored chromatography strips become useless when they are not properly protected and stored. Case WO 94/24563, incorporated herein by reference, uses chromatography strips which can be isolated from the air, but no additional measures are provided to protect the chromatography strips from moisture and oxygen.
SUMMARY OF THE INVENTION
The present invention resolves the aforementioned problems seen with the prior art chromatography immunoassay devices in terms of their mode and packaging, thereby providing a chromatography immunoassay device which is easier to use, can be isolated from moisture and/or oxygen more effectively, enabling storage over a longer period of time, and that is able to be produced at a lower cost.
A chromatography immunoassay device has been developed which can be used more easily, is protected from moisture and/or oxygen more effectively and has low production cost. This invention is a chromatography immunoassay device in which one or more chromatography strips are located on a substrate, each of the chromatography strips is sealed between the substrate and a seal film that entirely covers the chromatography strips, and the seal film and/or substrate possesses a film containing a dehumidifying agent and/or a film containing an oxygen absorbing agent.
Accordingly, the gist of the present invention resides in a chromatography immunoassay device in which: (1) one or more chromatography strips, having at least a sample adding means and a detecting means, are located at certain intervals on a substrate which is comprised of one plate, with or without a strip support, (2) a seal film that entirely covers the chromatography strips is located on the aforementioned chromatography strip with or without a protective laminate, (3) each of the chromatography strips is sealed by adhering the aforementioned seal film closely to a portion of the substrate around each chromatography strip, (4) the aforementioned adhesion of the seal film to the substrate is effected in such a way that the seal film can be peeled easily from the substrate, at least at the sample-adding area, (5) with regard to the seal film and substrate, (i) either the seal film or substrate has both a film containing a dehumidifying agent and a film containing an oxygen absorbing agent, (ii) the seal film has either a film containing a dehumidifying agent or a film containing an oxygen absorbing agent, and the substrate has the other film, (iii) either the seal film or substrate has either the film containing a dehumidifying agent or the film containing an oxygen absorbing agent, and the other has both the film containing a dehumidifying agent and the film containing an oxygen absorbing agent, (iv) both the seal film and substrate each contain both the film containing a dehumidifying agent and the film containing an oxygen absorbing agent, (v) the seal film and the substrate both contain the same film which is either the film containing a dehumidifying agent or the film containing an oxygen absorbing agent, or (vi) either the seal film or substrate contains either the film containing a dehumidifying agent or the film containing an oxygen absorbing agent, and (6) the seal film and substrate are substantially water impermeable, at least at the portion where the seal film is not adhered closely to the substrate when the seal film and/or substrate has the film containing a dehumidifying agent, and the seal film and substrate are substantially oxygen impermeable, at least at the portion where the seal film is not adhered closely to the substrate when the seal film and/or substrate has the film containing an oxygen absorbing agent.
EFFECT OF THE INVENTION
A chromatography immunoassay device is described which can be used easily, is protected from moisture and/or oxygen and has low production cost. This invention is a chromatography immunoassay device in which one or more chromatography strips are stuck on a substrate made of a single plate, each of the chromatography strips is sealed by closely adhering a substrate portion surrounding each chromatography strip to a seal film located on the aforementioned chromatography strip, and the seal film and/or substrate is possessed of a film containing a dehumidifying agent and/or a film containing an oxygen absorbing agent. Since chromatography strips are isolated from moisture and/or oxygen by the seal film and substrate, they can be stored for a more prolonged period of time. Also, even in the case of a device in which a plurality of chromatography strips are stuck on a substrate, when one chromatography strip is used the remaining chromatography strips are not exposed to air, unlike similar types of conventional devices currently in use. Also, a chromatography strip in the invention herein can be separated from other strips, together with the substrate, without exposing it to air before or after its use. In addition, the chromatography immunoassay device of the present invention does not require labor for packaging which is needed to produce the chromatography strips of the prior art. Th
Abbott Laboratories
Anderson Regina M.
Chin Christopher L.
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