Analyte assaying device

• US 6,277,650 B1
• Filed: 12/31/1998
• Issued: 08/21/2001
• Est. Priority Date: 10/24/1997
• Status: Expired due to Term

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Carter-Wallace Incorporated
• Inventors: Nazareth, Albert R., Boyle, Mary Beth, Cheng, Yea-Shun
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/224,950
• Time in Patent Office: 964 Days
• Field of Search: 422/55-58, 422/68.1, 422/69, 422/70, 435/4, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/810, 435/970, 435/971, 436/514, 436/518, 436/805, 436/810
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/971 Capture of complex after antigen-antibody reaction
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/814 Pregnancy
• CPC Class Codes: Y10S 436/818 Human chorionic gonadotropin

Abstract

The invention is an improved single-step test device for detecting the presence of a pre-selected analyte in a urine stream. The device includes a hollow rectangular outer casing and an assay material disposed within co-joined upper and lower sections of the casing. The outer casing includes a urine inlet port; a viewing window in the upper section; at least the upper section consisting of transparent material; and may also include at least one drainage vent spaced about the urine inlet port. The assay material is a sorptive material including: 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 a liquid sample between the urine sample application region and the analyte capture region. The flow of urine in the fluid path is observable through the transparent upper section for confirming a test is operative. 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.

Claims

1. A method for producing a device that detects the presence of an analyte in a urine stream, the method comprising the steps of:

providing an assay material in one portion having a capture region for binding the analyte, and in another portion a urine sample receiving region;

providing a casing defining;

a hollow housing for receiving the assay material, said housing including an upper section co-joined to a lower section;

a urine inlet port for permitting urine applied directly from a urine stream to enter the casing and to contact the urine sample receiving region of the assay material, and to travel by sorptive transport therefrom to said capture region of the assay material; and

a window in said upper section spaced apart from the urine inlet port for viewing the capture region;

enclosing the assay material within the casing; and

making said upper section of said casing of transparent material for permitting a user, immediately after applying urine into said urine inlet port, to observe movement of urine and a reconstituted direct labeled reagent along a flow path of said assay material from proximate said urine sample region toward said capture region, to thereby determine that a test is working.

2. The method of claim 1, further including the step of providing said casing with at least one drainage vent to permit excess urine entering the casing through the urine inlet port to exit the casing thereby to minimize hydraulic flooding of the casing.

3. The method of claim 1, further including making the lower section of said casing of opaque material.

4. The method of claim 1, further including making the lower section of said casing of transparent material.

5. The method of claim 1, further including making said casing rectangular.

6. A method for producing a device that detects the presence of an analyte in a urine stream, the method comprising the steps of:

providing a housing enclosing a test strip having in one portion a capture region for binding said analyte, and in another portion a urine stream sample receiving region;

providing an open urine inlet port in one section of said housing over said urine stream sample receiving region;

providing an open window in another section of said housing over said capture region; and

making at least a portion of said housing between said urine stream sample receiving region and said capture region of transparent material, for permitting a user to view the movement of reagents and/or sample liquid along said test strip inside said housing, to thereby determine that a test is working.

7. The method of claim 6, further including the step of:

providing at leas t one drainage vent in said housing for permitting excess urine to exit said housing.