Analytical test device and method of use

• US 6,140,136 A
• Filed: 09/18/1998
• Issued: 10/31/2000
• Est. Priority Date: 09/18/1998
• Status: Expired due to Fees

• Current Assignee: Syntron Bioresearch, Inc.
• Original Assignee: Syntron Bioresearch, Inc.
• Inventors: Lee, Jin Po
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/156,770
• Time in Patent Office: 774 Days
• Field of Search: 436/518, 436/524, 436/530, 436/541, 436/807, 435/7.1, 435/7.93, 435/7.94, 435/287.7, 435/287.9, 435/288.7, 435/970, 422/56, 422/99, 422/58, 422/104, 422/59, 422/60
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• 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 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

The present invention provides an analytical test device for conducting assays of biological fluids. Methods for carrying out the assays with the disclosed analytical test device are also provided.

Claims

1. An analytical test device, comprising a housing comprising:

(a) a top having one or more display ports;

(b) a bottom;

I) the top or the bottom further having a receiving port or together the top and the bottom forming a receiving port for receiving a container comprising an absorbent sample receiving pad;

(c) a test strip comprising an absorbent membrane, a reaction membrane having one or more reagents that form a reaction complex with an analyte in a fluid sample;

(d) an absorbent sample receiving pad in a container; and

(e) a stopping means,

wherein the absorbent membrane and the reaction membrane are in fluid flow contact with one another;

the strip is placed in the bottom such that the reaction membrane is visible through the one or more display ports and the absorbent membrane is towards the receiving port; and

in the assembled top and bottom the absorbent sample receiving pad is slidably insertable through the receiving port until further insertion is stopped by the stopping means, which places the absorbent sample receiving pad in fluid flow contact with the absorbent membrane.

2. The analytical test device of claim 1, wherein the bottom further comprises a slope with an upper and lower end, and upper plan attached to the upper end of the slope, and a lower plane attached to the lower end of the slope.

3. The analytical test device of claim 2, wherein the top further comprises a vertical bar that deflects the absorbent membrane to follow the contour of the slope.

4. The analytical test device of claim 1, wherein the stopping means is the container contacting the outside of the assembled top and bottom at the receiving port.

5. The analytical test device of claim 1, wherein the bottom further comprises a horizontal bar inside the assembled top and bottom and is the stopping means.

6. The analytical test device of claim 5, wherein the stopping means is the horizontal bar contacting the container.

7. The analytical test device of claim 1, further containing one or more labeled reagents which migrates with the sample and are deposited on the absorbent membrane at a point spatially separated from the point at which the absorbent sample receiving pad first contacts the absorbent membrane.

8. The analytical test device of claim 7, wherein immobilized to the reaction membrane is:

(a) an immobilized reagent complementary to an analyte in the fluid sample at a point beneath a first display port; and

(b) an immobilized control reagent complementary to the labeled reagent at a point beneath a second display port.

9. The analytical test device of claim 7, wherein bound to the reaction membrane at a point beneath a first display port is an immobilized reagent, wherein the analyte and the labeled reagent compete for binding to the immobilized reagent, or wherein the immobilized reagent and the analyte compete for binding to the labeled reagent.

10. The analytical device of claim 1 further comprising a groove along one side of the housing and a knob connected to said container, wherein said knob slides along said groove to control movement of said container in said housing.

11. A method for detecting an analyte in a fluid sample, comprising the steps of:

(a) adding the fluid sample to the absorbent sample receiving pad of the analytical test device claim 1;

(b) inserting the absorbent sample receiving pad into the receiving port until the absorbent sample receiving pad is stopped by the stopping means;

(c) detecting the analyte by observing a reaction complex through the one or more display ports.

12. The method according to claim 11, wherein the reaction complex is visible.

13. A method for detecting an analyte in a fluid sample using the device of claim 10, comprising the steps of:

(a) sliding the container comprising the absorbent sample receiving pad into a position for receiving a sample;

(b) adding fluid sample to the absorbent sample receiving pad;

(c) sliding the container comprising the absorbent sample receiving pad into a position in fluid flow contact with the absorbent membrane;

(d) detecting the analyte by observing a reaction complex through the one or more display ports.