Reading device, method, and system for conducting lateral flow assays

• US 8,367,013 B2
• Filed: 12/24/2001
• Issued: 02/05/2013
• Est. Priority Date: 12/24/2001
• Status: Expired due to Fees

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Kaylor, Rosann, Yang, Difei, Knotts, Michael
• Primary Examiner(s): Alexander, Lyle
• Application Number:
  US10/035,013
• Publication Number:
  US 20030119202A1
• Time in Patent Office: 4,061 Days
• Field of Search: 422/58, 422/61, 422400-403, 436/164, 436/166, 436/169, 436/174
• US Class Current: 422/403
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• 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

Abstract

An optical reflectance kit including a reading device and membrane test strip is disclosed for conducting a lateral flow assay. The reading device is portable. Assays may be conducted on bodily fluids to detect with high sensitivity the presence of certain hormones, glucose, or other bodily fluids of interest. Membrane test strips may receive a test fluid or test sample containing an analyte to be detected. The membrane test strips may be inserted directly into a receiving port of a reading device. Shielding stray light from the receiving port improves sensitivity and reduces the entry of stray or ambient light into the reading device. The reading device also includes one or more sensors capable of detecting the intensity of reflected electromagnetic radiation.

Claims

1. A system for conducting a lateral flow assay to detect the presence or quantity of an analyte in a sample, the system comprising:

(a) a lateral flow membrane strip comprising a detection zone, wherein upon application, the sample is capable of traversing through the membrane strip to the detection zone; and

(b) a reading device comprising;

(i) a housing within which is contained an electromagnetic radiation source and a sensor capable of detecting the intensity of electromagnetic radiation, wherein the electromagnetic radiation source and sensor are positioned so that electromagnetic radiation emitted from the source is capable of being reflected from the lateral flow membrane strip to the sensor, the housing having an exterior surface;

(ii) a light barrier structure comprising a top plate and a bottom plate, the bottom plate being positioned adjacent to the exterior surface of the housing, wherein a receiving port is defined between the top plate and the bottom plate, the lateral flow membrane strip being capable of insertion into the receiving port, wherein the bottom plate defines an aperture through which electromagnetic radiation from the source is capable of passing before contacting the lateral flow membrane strip, the aperture having a size that approximates the size of the detection zone; and

(iii) a light absorbing member positioned within the receiving port to absorb stray light, the light absorbing member comprising an absorption pad that is located adjacent to the membrane strip upon insertion into the receiving port, the absorption pad covering an area under which the membrane strip is impacted by electromagnetic radiation.

2. The system of claim 1, further comprising a pressure plate that is positioned in the receiving port between the top plate and the bottom plate for bearing against the lateral flow membrane strip upon insertion.

3. The system of claim 2, wherein the pressure plate is spring loaded.

4. The system of claim 1, wherein the light-absorbing member comprises a flexible material.

5. The system of claim 1, wherein the receiving port defines a first stop position for a reference reading and a second stop position for a sample reading.

6. The system of claim 5, wherein one or more of the stop positions is formed by notches in the bottom plate.

7. The system of claim 1, wherein a capture reagent is immobilized within the detection zone, the capture reagent being configured to directly or indirectly bind to the analyte.

8. The system of claim 1, wherein the aperture is elongated.

9. The system of claim 1, wherein the aperture is circular.

10. The system of claim 1, wherein the area of the aperture is 1.8 times or less than the area of the detection zone.

11. The system of claim 1, wherein the area of the aperture is 1.3 times or less than the area of the detection zone.

12. The system of claim 1, wherein the electromagnetic radiation source comprises a light emitting diode.

13. The system of claim 1, wherein the sensor comprises a photodiode.

14. The system of claim 1, further comprising a display for providing results of the assay.

15. The system of claim 1, further comprising a sample pad in fluid communication with the membrane strip, the sample pad defining the point of application for the sample.

16. The system of claim 1, further comprising a wicking pad in fluid communication with the membrane strip.