Test kit and use thereof

Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Sample mechanical transport means in or for automated...

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422 681, 422 58, 422104, 422162, 436541, 436183, 436513, 4352871, 4352876, 4352882, 4352885, 206469, 206532, 206569, G01N 3122, G01N 1506, B01L 900, C01B 600, C12M 100

Patent

active

060903473

DESCRIPTION:

BRIEF SUMMARY
AREA OF THE INVENTION

The present invention relates to test kits with test vessels which are formed by appropriate shaping of a plastic sheet and welding of this shaped sheet to a substrate, and to the use thereof for carrying out analytical tests, in particular immunological tests.
Vessels which are formed, as described above, by shaping a plastic sheet and welding this sheet to a substrate are referred to as "blisters" in the art. The blister technique is used in particular for packaging tablets or pills of all types. However, it is also employed for packing biological and technical products; thus, for example, flower bulbs or screws are blister-packed.


PRIOR ART

The blister technique has already been employed in analysis for carrying out tests of various types. In the literature on such tests, the blisters are referred to not by their modern name but as bags, envelopes and the like.
Thus, according to FR 2 351 022 (R. Boutroy), elongate bags are formed from two plastic sheets which are welded together; the bags taper to a point at the lower end and are left open at the upper end. After introduction of, for example, a serum sample, the opening is heat-sealed. To remove the sample, the point is cut through or slit open at the side. The bags are intended to be used for storage, centrifugation or transport of samples.
U.S. Pat. No. 3,660,033 (L. L. Schwartz) describes a flexible polyethylene bag for analysis of, for example, a urine sample. The bag comprises successively a sample entrance, a reservoir which can be sealed with respect to the former, and a reaction chamber which contains a reagent for the sample and is connected to the reservoir by a narrow, sealable channel. Part of the sample passes from the reservoir into the reaction chamber, and the remainder can be stored or used for other tests; for this purpose, the connection orifices are closed and the reservoir is detached along the cut lines.
The Patent Application WO 91/16086 (Target Research Inc.) describes a transparent plastic bag for the analysis of physiological fluids. The edge on the upper half of the bag is open for introducing samples; the lower half is formed into a plurality of compartments which are open on the upper half but sealable, and taper at the lower end to a point which can be cut through, and can be detached singly along the welding lines. The compartments, which are arranged on at least one of the halves of the bag, receive individual samples, which are brought into contact with chemical reagents.
Many analytical tests make use of a test strip which contains agents necessary for the test on porous material (for example cellulose, nitrocellulose). During some test methods, the test strip must be washed one or more times with washing solution.
EP 0 139 373 (The Regents of the University of California) describes a test kit inter alia for an ELISA test (Enzyme-Linked Immuno Sorbent Assay). This test kit does not, however, use the blister technique. It consists of a test strip in the form of a column which is composed of several layers of, for example, filter paper or plastic and which is located in a glass tube which is open at both ends. One or more layers of the column carry a reagent bound thereto, in particular a known antigen or the corresponding antibody; they are kept at a distance apart by inert separating layers. The solution to be tested, as well as possible washing solutions, are sucked into the tube by applying a vacuum to the upper end of the tube. The solutions are removed from the tube by applying a superatmospheric pressure.
The Patent Application WO 93/07474 (Hawaii Chemtect International) describes an analytical kit for testing foodstuffs, in particular for detecting fish toxins. It comprises a stiff but flexible, non-porous, preferably water-resistant substrate to which a transparent plastic sheet which is shaped to blisters is affixed. The blisters contain liquid reagents. Half way along, the sheet and substrate have a bending line which also runs through the upper part of the blisters. If the kit is ben

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