Diagnostic detection device

The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device has a hollow outer casing and an assay material disposed within the casing. The outer casing defines: a urine inlet port; a viewing window; and at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material defining: a urine sample application region adjacent to, and in fluid communication with the urine inlet port; a capture region adjacent to the viewing window; and a fluid flow path for transporting liquid sample between the urine sample application region and the analyte capture region. The drainage vent is located to permit excess urine entering the casing from the urine stream to exit the casing thereby to minimize hydraulic pressure induced flooding of the assay material disposed within the casing and to reduce the frequency of false test results.

What is claimed is:

1. A single-step device for detecting the presence of an analyte in a urine stream, the device comprising:

an assay material comprising a release medium of a first material and a releasable, visually detectable analyte binding reagent disposed thereon for release therefrom, and in fluid communication and downstream thereof, a capture medium of a second, different material and a capture reagent immobilized thereon for binding the analyte; and

a casing defining

a hollow housing enclosing the assay material,

a urine inlet port through which urine applied directly from the urine stream enters the casing and contacts the assay material upstream of the release medium,

a window spaced apart from the urine inlet port for viewing the capture medium, and

at least one drainage vent spaced apart from the urine inlet port and upstream of the release medium through which excess urine entering the casing through the urine inlet port drains from the casing thereby minimizing hydraulic pressure induced flooding of the release medium or the capture medium of the assay material disposed within the casing.

2. A single-step device for detecting the presence of an analyte in a urine stream, the device comprising:

an assay material comprising a urine sample application medium, in fluid communication and downstream thereof, a release medium of a first material and a releasable, visually detectable analyte binding reagent disposed thereon for release therefrom, and in fluid communication and downstream thereof, a capture medium of a second, different material and a capture reagent immobilized thereon for binding the analyte; and

a casing defining

a hollow housing enclosing the assay material,

a urine inlet port adjacent the urine sample application medium through which urine applied directly from the urine stream enters the casing and contacts the assay material at the sample application medium,

a window spaced apart from the urine inlet port for viewing the capture medium, and

at least one drainage vent spaced apart from the urine inlet port and upstream of the release medium through which urine entering the casing through the urine inlet port drains from the casing thereby minimizing accumulation of the applied urine in an amount sufficient to flood the release medium or the capture medium of the assay material disposed within the casing.

3. The device of claim 1 or 2 wherein the casing defines three drainage vents.

4. The device of claim 1 or 2 wherein the window is located on a side of the casing opposite from the urine inlet port.

5. The device of claim 1 or 2 wherein the casing defines a single drainage vent.

6. The device of claim 1 or 2 wherein the visually detectable analyte binding reagent is a conjugate of an antibody and a visually detectable moiety.

7. The device of claim 6 wherein the antibody is a monoclonal antibody.

8. The device of claim 6 wherein the antibody is an anti-chorionic gonadotropin antibody.

9. The device of claim 6 wherein the visually detectable moiety is a colloidal gold particle.

10. The device of claim 1 or 2 wherein the release medium further comprises a biotinylated binder of the analyte releasably disposed thereon for release therefrom.

11. The device of claim 10, wherein the capture reagent is streptavidin.

12. The device of claim 1 or 2, wherein the capture medium is nitrocellulose.

13. A method for detecting the presence of an analyte in a urine stream suspected to contain the analyte, the method comprising the steps of:

(a) providing a single-step device comprising

an assay material comprising a release medium of a first material and a releasable, visually detectable analyte binding reagent disposed thereon for release therefrom, and in fluid communication and downstream thereof, a capture medium of a second, different material and a capture reagent immobilized thereon for binding the analyte, and

a casing defining

a hollow housing enclosing the assay material,

a urine inlet port through which urine applied directly from the urine stream enters the casing and contacts the assay material upstream of the release medium,

a window spaced apart from the urine inlet port for viewing the capture medium, and

at least one drainage vent spaced apart from the urine inlet port and upstream of the release medium through which excess urine entering the casing through the urine inlet port drains from the casing thereby minimizing hydraulic pressure induced flooding of the release medium or the capture medium of the assay material disposed within the casing;

(b) applying urine from the urine stream to the urine inlet port; and

(c) observing the presence or absence of an accumulation of the visually detectable analyte binding reagent immobilized at the capture medium, the accumulation of the visually detectable analyte binding reagent being indicative of the presence of the analyte in the urine.

14. A method for producing a single-step device for detecting an analyte in urine, the method comprising:

(1) providing an assay material comprising a release medium of a first material and a releasable, visually detectable analyte binding reagent disposed thereon for release therefrom, and in fluid communication and downstream thereof, a capture medium of a second, different material and a capture reagent immobilized thereon for binding the analyte;

(2) providing a casing defining

a hollow housing for receiving the assay material,

a urine inlet port through which urine applied directly from a urine stream enters the casing and contacts the assay material at a position upstream of the release medium when disposed within the casing,

a window spaced apart from the urine inlet port for viewing the capture medium of the assay material when disposed within the casing, and

at least one drainage vent spaced apart from the urine inlet port and upstream of the release medium of the assay material when disposed within the casing through which excess urine entering the casing through the urine inlet port drains from the casing thereby minimizing hydraulic pressure induced flooding of the release medium or the capture medium of the assay material when disposed within the casing; and

(3) enclosing the assay material within the casing.

15. The method of claim 14, wherein the capture medium is nitrocellulose.

16. A method for detecting the presence of an analyte in a urine stream suspected to contain the analyte, the method comprising the steps of:

(a) providing a single-step comprising

an assay material comprising a urine sample application medium, in fluid communication and downstream thereof, a release medium of a first material and a releasable, visually detectable analyte binding reagent disposed thereon for release therefrom, and in fluid communication and downstream thereof, a capture medium of a second, different material and a capture reagent immobilized thereon for binding the analyte, and

a casing defining

a hollow housing enclosing the assay material,

a urine inlet port adjacent the urine sample application medium through which urine applied directly from the urine stream enters the casing and contacts the assay material at the sample application medium,

a window spaced apart from the urine inlet port for viewing the capture medium, and

at least one drainage vent spaced apart from the urine inlet port and upstream of the release medium through which urine entering the casing through the urine inlet port drains from the casing thereby minimizing accumulation of the applied urine in an amount sufficient to flood the release medium or the capture medium of the assay material disposed within the casing;

(b) applying urine from the urine stream to the urine inlet port; and

(c) observing the presence or absence of an accumulation of the visually detectable analyte binding reagent immobilized at the capture medium, the accumulation of the visually detectable analyte binding reagent being indicative of the presence of the analyte in the urine.