Devices for use in chemical test procedures

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156 61, 204403, 350 963, 356244, 356440, 422 8211, 422102, 427 2, 435 7, 435288, 435301, 435311, G01N 2101

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049785036

DESCRIPTION:

BRIEF SUMMARY
This invention relates to devices for use in chemical (especially biochemical or clinical) test procedures, to processes for their manufacture, and to the uses of the devices.
The devices are, in certain embodiments, intended for use in specific binding assay procedures, among which an important group is constituted by immunoassay procedures. Examples of such immuno assays, especially enzyme-linked immunoassays, are cited in Specifications Nos. EP 0 042 755, GB 2 074 727, GB 2 086 041, and GB 1 548 741.
Previously, immunoassay procedures have often been carried out using so-called microtitre wells, conventionally of about 0.5 ml working capacity, amongst a variety of other liquid containers for the assay reaction liquids. Other devices and arrangements for handling immunoassay materials are described in Specifications Nos. EP 0 31 993, GB 1 571 872, GB 1 584 129 and GB 1 414 479, for example.
In particular, the prior art contains numerous disclosures of analytical devices for handling and metering small volumes of test samples.
GB 2 090 659 (Instrumentation Laboratory, Inc.) describes test strips constructed with a self-filling metering channel and a lip or inlet on which a sample of more than about 10 microliters of for example whole blood can be placed, so that (for example) 10 microliters is taken up by capillary action to react with a reagent carried on a fibrous pad above a filter layer beneath a transparent window. The result can be viewed by the unaided eye, e.g. as a colour reaction.
GB 2 036 075 (H E Mennier), GB 1 104 774 (J P Gallagher), EP 0 057 110, 0 034 049, 0 010 456 (Kodak), all describe some other aspect of the uses of capillary channel or chamber dimensions for handling biological or test fluids.
GB 1 530 997 (Monsanto) describes the use of coated optical fibres which can be used in tests that change the light transmitting capabilities of the waveguides via reactions of the coatings, e.g. antigen-antibody reactions. WO 81/00912 (Buckles) also describes fibre-optic devices in which the fibre surface or surroundings modify the light transmission through the core.
USP 3 939 350 describes optical measurement of fluorescent material bound to the surface of a solid transparent prism by a method involving a single total internal reflection and interaction of the evanescent wave at the surface of the prism with the bound material.
EP 0 075 353 (Battelle) makes specific reference to the exponentially-decaying (evanescent) external radiation due to light which is propagated longitudinally in a fibre, and its interaction with coatings, and this principle is also taken up in the immunoassay test devices of EP 0 103 426 (Block) in which light of fluorescence excitation as well as emission wavelengths is propagated within a antigen--or antibody--coated optical fibre or plate contacting a capillary-dimensional sample liquid volume bounded by a tube or another plate and containing a fluorescent-tagged binding partner of the material coated on the fibre or plate.
According to the invention to be described here, capillary fill cell devices which can be conveniently manufactured, are provided to facilitate in particular specific binding assays using very small liquid samples.
According to the invention we provide a specifically-reactive sample-collecting and testing device possessing a cavity or cavities each having a dimension small enough to enable sample liquid to be drawn into the cavity by capillary action, wherein a surface of the cavity carries an immobilised reagent appropriate to the test to be carried out in the device, and wherein said surface is a surface of a transparent solid plate to act as a light-transmissive waveguide and forming a wall of the cavity, said plate having an edge which is substantially optically smooth and transverse, e.g. at some transverse angle but most preferably perpendicular, to the plane of the plate.
The devices enable convenient sample collection and carrying out optical analysis in situ of the products of reaction of the sample with reagent(s) contained in the devi

REFERENCES:
patent: 4050895 (1977-09-01), Hardy et al.
patent: 4327073 (1982-04-01), Huang
patent: 4447546 (1984-05-01), Hirschfeld
patent: 4582684 (1986-04-01), Vogel
patent: 4591550 (1986-05-01), Hafeman et al.
patent: 4654532 (1987-03-01), Hirschfeld
patent: 4880752 (1989-11-01), Keck et al.
Chabay, Analytical Chemistry, 54 (9), pp. 1071(A)-1080(A).

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