DEVICE AND METHOD FOR DETECTION OF ANALYTES
The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.
1 . A device for detecting the presence or amount of a substance of interest in a liquid sample, the device comprising:
a sample receiving zone for receiving a liquid sample,
a sample filtering zone for filtering the liquid sample, wherein the sample receiving zone and the sample filtering zone are integral with a first element;
a second element including one or more specific binding pair members at a detection zone, the one or more specific binding pair members comprising a binding pair member for C. difficile glutamate dehydrogenase (GDH) that specifically binds to C. difficile GDH,
wherein the first and second elements are separate elements,
wherein at least a portion of the liquid sample received in the sample receiving zone is permitted to move in a substantially random, non-directional manner in an area comprising at least a portion of the detection zone.
2 . The device of claim 1 , wherein the one or more specific binding pair members further comprise a specific binding pair member for C. difficile toxin A that specifically binds to C. difficile toxin A.
3 . The device of claim 2 , wherein the one or more specific binding pair members further comprise a specific binding pair member for C. difficile toxin B that specifically binds to C. difficile toxin B.
4 . The device of claim 3 , wherein the first and second elements are in physical contact with one another.
5 . The device of claim 4 , wherein the first element comprises a porous material.
6 . The device of claim 5 , wherein the second element comprises a porous membrane.
7 . The device of claim 1 , wherein the specific binding pair member for C. difficile GDH is an antibody.
8 . The device of claim 2 , wherein the specific binding pair member for C. difficile toxin A is an antibody.
9 . The device of claim 3 , wherein the specific binding pair member for C. difficile toxin B is an antibody.
10 . The device of claim 1 , wherein the detection zone of the second element is positioned on top of at least a portion of the first element.
11 . The device of claim 1 , wherein the liquid sample comprises fecal matter.
12 . A device for detecting the presence or amount of a substance of interest in a liquid sample, the device comprising:
a porous material that comprises: 1) a sample receiving zone for receiving a liquid sample; and 2) a sample filtering zone for filtering at least a portion of the liquid sample received at the sample receiving zone, wherein the sample receiving zone and the sample filtering zone are integral with the porous material; and
a porous membrane that is a separate element than the porous material, the porous membrane comprising one or more specific binding pair members immobilized to at least a portion of the porous membrane, wherein the one or more specific binding pair members comprise: 1) a specific binding pair member for C. difficile glutamate dehydrogenase (GDH) that specifically binds to C. difficile GDH; 2) a specific binding pair member for C. difficile toxin A that specifically binds to C. difficile toxin A; and a specific binding pair member for C. difficile toxin B that specifically binds to C. difficile toxin B,
wherein at least a portion of the liquid sample received in the sample receiving zone is permitted to move in a substantially random, non-directional manner in an area comprising at least a portion of the detection zone.
13 . The device of claim 12 , wherein the porous material and the porous membrane are in physical contact with one another.
14 . The device of claim 13 , wherein the porous material and the porous membrane are in physical contact with one another in an area comprising the detection zone.
15 . The device of claim 14 , wherein the porous membrane is at least partly on top of the porous membrane over the area comprising the detection zone.
16 . The device of claim 12 , wherein the specific binding pair member for C. difficile GDH is an antibody, wherein the specific binding pair member for C. difficile toxin A is an antibody, and wherein the specific binding pair member for C. difficile toxin B is an antibody.
17 . The device of claim 12 , wherein the liquid sample comprises fecal matter.