Semi-permeable capillary assay device

#The invention relates to a device and the use of the device for detecting and/or determining an analyte in a test liquid and a method for detecting and/or determining an analyte in said test liquid.

#The field of specific binding assays has greatly expanded as its importance in the diagnostic field has become recognized. The ability to detect a specific compound and measure the compound quantitatively has permitted the monitoring of the administration of a wide variety of drugs, the determination of an imbalance in a wide variety of hormones, the quantitation of physiologically active proteins and the diagnosis of the presence of a pathogen. Different techniques have been distinguished in requiring or not requiring separation steps, the nature of the signal developed by the label, the development of the signal in a solution or on a surface and the manner of measurement for quantitative determination.

#In developing an assay, there are a number of considerations in devising the reagents and protocol. One consideration is the degree of sophistication of the individual performing the assay. There are a lot of situations where it is desirable that a relatively untrained or unexperienced individual should be able to perform an assay and obtain reasonably quantitative results. It is particularly desirable that the untrained person be able to perform a quantitative assay with a rapid simple test without the need for sophisticated instruments.

#FIG. 1 is a drawing of one embodiment of the device.

#A particular embodiment of the device is a device in which the track is a capillary canal e.g. a porous hollow fibre of e.g. polyethersulfone, polyamide, polyimide or regenerated cellulose, containing walls that are semi-permeable and that is at least partly surrounded by absorbent material and in which this canal is used to forward, by capillary force, the movable solid phase material e.g. a watery suspension of particles coated with a ligand. The semi-permeable wall is capable of letting molecules pass, molecules e.g. contaminations or particles smaller than said coated particles, e.g. molecules, through its pores, however not the said coated particles.

#The pores may be present in the semi-permeable wall in e.g. a tortuous, parallel or at an approximate perpendicular orientation.

#The capillary canal may end in, or depart from, stations containing reagents, which reagents may be said suspension, labelled or non-labelled specific reactants or a specific substrate to detect the labelled reactant.