ELECTRONIC ANALYTE ASSAYING DEVICE

• US 20100239460A1
• Filed: 06/03/2010
• Published: 09/23/2010
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Church & Dwight Company Incorporated
• Inventors: Delahanty, Francis T., Bandru, Gregory M., Synakowski, Stephen R., Wieck, Henry J., Nazareth, Albert R.
• Granted Patent: US 8,722,395 B2
• Time in Patent Office: Days
• US Class Current: 422/58
• 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 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads

Abstract

The invention is an electronically processed single-step test device for detecting the presence of a preselected analyte in a fluid. The device includes a hollow rectangular outer casing, disposed within co-joined upper and lower sections of the casing are assay material, an electronic processing system, and a LCD display. The LCD display is observable through a viewing window. The assay material is a sorptive material including a fluid sample application region in the form of a sample wick in fluid communication with a test strip. The test strip includes an analyte capture region adjacent to a light shield. The electronic processing system includes red and green LEDs which are alternately pulsed or energized over predetermined periods of time to determine if fluid test results show a marker or markers in the capture region indicative of the presence of a preselected analyte in the fluid. If so, Yes+ is displayed on the LCD. If not, No− is displayed on the LCD.

Claims

1. A diagnostic device for detecting the presence of an analyte in a fluid sample, the device comprising:

a. a casing having a display;

b. a light shield having

(i) a first surface and a second surface,

(ii) a first end and a second end, and

(iii) a first and a second passageway extending between said light shield first and second surfaces, each passageway defining an opening in said light shield first and second surfaces,

wherein said light shield is received in said casing;

c. a lateral flow diagnostic strip having a capture region,

d. a processor received in said casing;

e. at least one light source received in said casing adjacent said first passageway at said light shield second surface, said at least one light source being operatively coupled to said processor;

f. at least one sensor received in said casing adjacent said second passageway at said light shield second surface, said at least one sensor being operatively coupled to said processor;

wherein said lateral flow diagnostic strip is positioned adjacent said light shield second surface so that a gap exists between said lateral flow diagnostic strip and said first and said second passageway openings at said light shield second surface.

2. The device of claim 1, said lateral flow diagnostic strip further comprising a registration recess configured to receive a portion of said light shield to properly align said lateral flow diagnostic strip capture region with at least one of said first and said second passageways.

3. The device of claim 1, wherein

a. said at least one light source is a light emitting diode;

and

b. said at least one sensor is a photo detector.

4. The device of claim 1, further comprising a printed circuit board mounted adjacent to said light shield first surface, said processor, said at least one light source and said at least one sensor being mounted on said printed circuit board.

5. The device of claim 4, wherein said display is a digital display that is operatively coupled to said printed circuit board.

6. The device of claim 1, said light shield further comprising first and second longitudinal rails formed on said light shield second surface and extending between said light shield first and second ends.

7. The device of claim 6, wherein said first and second longitudinal rails terminate prior to reaching said light shield first and second ends.

8. The device of claim 6, wherein said lateral flow diagnostic strip rests on said light shield first and second longitudinal rails so that a surface of said lateral flow diagnostic strip is spaced apart from said light shield second surface to form said gap between said lateral flow diagnostic strip and said second surface first and second passageway openings.

9. The device of claim 1, wherein said processor is a software driven processor.

10. The device of claim 1, wherein said processor is a state machine.

11. A diagnostic device for detecting the presence of an analyte in a fluid sample, the device comprising:

a. a casing having a display window;

b. a light shield having

(i) first and second surfaces,

(ii) first and second ends, and

(iii) first and second passageway extending between said light shield first and second surfaces, each passageway defining an opening in said light shield first and second surfaces,

wherein said light shield is received in said casing;

c. a lateral flow diagnostic strip received in said casing adjacent said light shield second surface so that a gap exists between a surface of said lateral flow diagnostic strip and said light shield second surface passageway openings,

d. a processor mounted in said casing;

e. at least one light emitting diode mounted in said casing and operatively coupled to said processor so that light emitted from said diode is projected through said light shield second surface first passageway opening;

f. at least one photo detector mounted in said casing and operatively coupled to said processor so that light reflected from said lateral flow diagnostic strip surface is received in said light shield second surface second passageway opening and directed to said at least one photo detector.

12. The device of claim 11, said lateral flow diagnostic strip further comprising a registration opening configured to receive a portion of said light shield to properly align said lateral flow diagnostic strip with at least one of said first and said second passageways.

13. The device of claim 11, further comprising a printed circuit board, said processor, said at least one photo detector and said at least one light emitting diode being mounted on said printed circuit board.

14. The device of claim 13, wherein said printed circuit board is mounted adjacent said light shield first surface.

15. The device of claim 11, said light shield further comprising first and second supports formed on said light shield second surface.

16. The device of claim 15, wherein said light shield first and second supports engage said lateral flow diagnostic strip surface to space said first and said second light shield second surface passageway openings apart from said lateral flow diagnostic strip surface.

17. The device of claim 15, wherein said first and said second light shield supports extend longitudinally along a length of said lateral flow diagnostic strip.

18. The device of claim 11, wherein said processor is a software driven processor.

19. A diagnostic device for detecting the presence of an analyte in a fluid sample, the device comprising:

a. a casing;

b. a light shield having

(i) first and second surfaces, wherein a portion of said second surface is recessed,

(ii) first and second ends, and

(iii) at least one passageway extending between said light shield first and second surfaces, said at least one passageway defining an opening in said light shield first surface and said second surface recess,

wherein said light shield is received in said casing;

c. a lateral flow diagnostic strip received in said casing adjacent said light shield second surface recess so that a gap exists between a surface of said lateral flow diagnostic strip and said light shield second surface passageway opening,

d. a processor mounted in said casing;

e. at least one light emitting diode mounted in said casing and operatively coupled to said processor so that light emitted from said diode is projected on said lateral flow diagnostic strip;

f. at least one photo detector mounted in said casing and operatively coupled to said processor so that light reflected from said lateral flow diagnostic strip surface is received in said light shield second surface at least one passageway opening and directed to said at least one photo detector.

20. The device of claim 19, further comprising a second passageway extending between said light shield first and second surfaces, said second passageway defining an opening is said light shield first surface and said second surface recess, wherein said at least one light emitting diode is mounted adjacent said light shield first surface second passageway so that light is projected onto said lateral flow diagnostic strip

21. The device of claim 19, wherein said processor is a software driven processor.