Device for analytical determinations

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

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422 58, 422 61, 422 681, 435287, 435291, 436518, G01N 2100, G01N 33561, C12M 134

Patent

active

051165767

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a device for carrying out analytical determinations and, in particular, to a device for carrying out a specific binding assay such as an immunoassay.
There is a great deal of interest in the simplification of analytical techniques to allow the unskilled user to carry out complex assay procedures without error. This is particularly relevant to the field of immunoassays which, in the healthcare field, have been taken out of the clinical laboratory and which are now used in clinics, doctor's offices, veterinary surgeries and even beside the patient or animal. This has been made possible by the introduction of non-isotopic labels, such as enzymes which can give coloured end-points that may be interpreted visually, or measured in a simple instrument. In addition new formats have been devised to simplify greatly the liquid handling of these assays, examples include the immunoconcentration device of Hybritech, U.S. Pat. No. 4,376,110, the inert porous medium of American Hospital Supply Corporation, PCT W082/02601, the concentrating zone method of Syva Company EP-A-0,046,004 and the absorbent matrix pad of Bagshawe, U.S. Pat. No. 3,888,629. In these assay devices the specific binding reactions such as antibody/antigen interactions take place in an absorbent matrix or membrane which is in contact with a quantity of material which acts as an absorber of liquids. In use the sample is applied to the matrix or membrane, further reagents are added, followed by a wash and the addition of an enzyme substrate (when an enzyme label is used). The disadvantage of this type of immunoassay format is that the reagents must be supplied separately i.e. for a manual assay the conjugate, wash buffer and enzyme substrate are made available in dropper bottles containing sufficient fluid to carry out a number of assays. For an assay carried out in an instrument these reagents must be added by complex pipetting methods. These separate reagents increase the complexity of the assay and introduce the possibility of error by an unskilled user introducing reagents in the wrong order or, in an automated device, greatly increase the complexity of the instrument.
Other immunoassay devices have been proposed that use an absorbent or non-absorbent dip-stick to which antibodies have been immobilized e.g. Unilever, EP-A-0,042,755, and Becton Dickinson and Company EP-A-0,194,789. In these devices the sample is contacted with the dip-stick, followed by the further addition of labelled reagents, a wash and the final addition of enzyme substrate (if an enzyme label is used) or the measurement of other labels by various means. The disadvantage of such a system is that the reagents must be added to containers into which the stick is dipped and a separate washing station such as a domestic sink may be required.
GB-A-2073416 describes a two-piece telescoping cylinder unit forming a disposable container for a swab tip and a liquid culture medium. A conical plug seals the liquid from the swab but when the telescoping part are pushed together the plug pivots so that the seal is broken and the liquid culture medium can come into contact with the swab.
EP-A-0206166 describes a test vial comprising a sealed chamber which contains a fluid medium and an open chamber which is external to the sealed chamber and supports the test article. A barrier separates the sealed and open chambers. The vial is equipped with means to penetrate the barrier and inject the test article into the fluid medium.
We have now developed a device for carrying out analytical determinations that contains all of the necessary reagents and wash solution to carry out biological assay or chemical analysis within the device.
According to the present invention there is provided a device for carrying out an analytical determination which comprises a plurality of separate discrete chambers which contain, successively, the reagents required to perform the desired analytical determination, the reagent chambers being separated one from another by a separation means whic

REFERENCES:
patent: 3723064 (1973-03-01), Liotta
patent: 3825410 (1974-07-01), Bagshawe
patent: 3933594 (1976-01-01), Milligan et al.
patent: 4770853 (1988-09-01), Bernstein
patent: 4842995 (1989-06-01), Iaccheri et al.
patent: 4898832 (1990-02-01), Klose et al.
patent: 4916078 (1990-04-01), Klose et al.

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