Immunoassay detection device with test strip accommodated in a capillary tube

Abstract

The present invention relates to a detection device for safe and convenient immunoassay of an analyte containing pathogens.

I claim: 
     
         1 . A detection device for detecting two or more pathogens or markers in an analyte comprises: a test device having a first major surface on which two or more test zones are defined, a first test zone having immobilised thereon a first capture ligand, adapted to bind to a first capture target on a first pathogen or marker; and a second test zone having immobilised thereon a second capture ligand, adapted to bind to a second capture target on a second pathogen or marker, in use, the device contacts a detection solution with a labelled probe which binds to a probe target on one or more of said pathogens or markers. 
     
     
         2 . A device according to  claim 1  wherein the device includes a control zone having a probe capture ligand immobilised within it. 
     
     
         3 . A device according to  claim 1  wherein a labelled probe is adapted to bind to probe targets present on both a first and a second pathogen or marker. 
     
     
         4 . A device according to  claim 1  wherein the detection solution comprises a first labelled probe adapted to bind selectively to a probe target on a first pathogen or marker and a second labelled probe adapted to bind selectively to a probe target on a second pathogen and marker. 
     
     
         5 . A device according to  claim 1  wherein a single test zone has immobilised within it both a first and a second capture ligand. 
     
     
         6 . A device according to  claim 1  wherein the test device is substantially planar and comprises a planar test strip having the first major surface and the test zones thereon, provided within a housing. 
     
     
         7 . A device according to  claim 1  further including a container having a closable internal space adapted to house the test device and adapted to receive an analyte such that the analyte contacts the first major surface and the test zones thereon, the test device being removable from the container. 
     
     
         8 . A device according to  claim 7  wherein the container is a tubular container having a wall, a first end, a second end and an internal space to receive an analyte, wherein the test device is provided within the internal space such that the first major surface is spaced apart from the wall, and the container comprises an opening at its first end closed by a septum and a cap at its second end openable to remove the test device. 
     
     
         9 . A device according to  claim 7  wherein the test device comprises a housing that interfits removably with the container to position the test device within the internal space. 
     
     
         10 . A device according to  claim 8  wherein the container comprises means to re-seal the cap once the test device has been removed. 
     
     
         11 . A device according to  claim 8  wherein the test device forms a seal to the opening of the container at the second end, such that sample is retained within the container while the test device is being removed. 
     
     
         12 . A device according to  claim 1  adapted such that the intensity of the probe in a test zone indicates the concentration of pathogen or marker within the analyte. 
     
     
         13 . A device according to  claim 1  comprising a reader adapted to measure the amount of bound probe. 
     
     
         14 . A device according to  claim 13  wherein the probe comprises an optical label and the reader is an optical reader. 
     
     
         15 . A device according to  claim 14  wherein the label is a fluorescent label and the reader is a fluorescence reader. 
     
     
         16 . A device according to  claim 7  wherein the container comprises an anticoagulant. 
     
     
         17 . A device according to  claim 7  wherein the interior of the container is at a pressure below atmospheric such that in use sample is drawn into the container by pressure. 
     
     
         18 . A device according to  claim 7  wherein the container has a volume between around 0.5 ml and around 10 ml. 
     
     
         19 . A system adapted to receive a device according to  claim 7  that includes a means for receiving the container; a means for introducing a sample into the container and introducing a detection solution with a labelled probe and adapted to receive an analyte, such that the analyte contacts the first major surface and the test zones thereon, the test device being removable from the container.