Electronic analyte assaying device

• US 10,168,322 B2
• Filed: 05/12/2014
• Issued: 01/01/2019
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Church & Dwight Company Incorporated
• Inventors: Nazareth, Albert R., Delahanty, Francis T., Bandru, Gregory M., Wieck, Henry J., Synakowski, Stephen R.
• Primary Examiner(s): Lam, Ann Y
• Application Number:
  US14/275,135
• Publication Number:
  US 20140248717A1
• Time in Patent Office: 1,695 Days
• Field of Search: None
• 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

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 display. The 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 system includes lights 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 display otherwise, No− is displayed on the display.

Claims

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

a housing configured to receive a lateral flow diagnostic strip, said lateral flow diagnostic strip including;

a receiving end for receiving the fluid sample;

a terminal end opposite said receiving end; and

a capture region located between said receiving end and said terminal end; and

a processor configured to, upon receiving the fluid sample;

illuminate the lateral flow diagnostic strip;

measure intensity values of light reflected from the lateral flow diagnostic strip;

obtain, during a first time period, a first series of intensity value pairs, wherein each intensity value pair of the first series of intensity value pairs comprises a measurement signal and a background signal, and wherein the measurement signal and the background signal for each intensity value pair of the first series of intensity value pairs are obtained at substantially the same time;

calculate the intensity difference between the measurement signal and the background signal for each pair of the first series of intensity value pairs to generate a first series of intensity difference values;

generate, at the end of the first time period, a fluid front detection result based at least in part on the first series of intensity difference values, wherein the fluid front detection result indicates whether at least a portion of the first series of intensity difference values correspond to a threshold for identifying a fluid front;

obtain, during a second time period, a second series of intensity value pairs, wherein each intensity value pair of the second series of intensity value pairs comprises a measurement signal and a background signal, and wherein the measurement signal and the background signal for each intensity value pair of the second series of intensity value pairs are obtained at substantially the same time;

calculate the intensity difference between the measurement signal and the background signal for each pair of the second series of intensity value pairs to generate a second series of intensity difference values; and

generate, at the end of the second time period, a message indicating that the analyte is present in the fluid sample based at least in part on;

(i) the fluid front detection result generated with the first series of intensity difference values obtained during the first time period, and

(ii) the second series of intensity difference values obtained during the second time period.

2. The device of claim 1, further comprising a sensor positioned within the housing and configured to detect the quantity of light reflected from said capture region.

3. The device of claim 2, wherein the sensor is a photo detector.

4. The device of claim 1, wherein quantities of light reflected during the first time period and the second time period are reflected from said capture region.

5. The device of claim 1, further comprising a display, wherein the processor is further configured to:

increment a fluid front counter based on a comparison between the threshold and an intensity difference value obtained during the first time period, wherein the fluid front detection result is generated based at least in part on the fluid front counter; and

generate a message for presentation via the display if said fluid front detection result indicates that the fluid front was not detected after the first time period.

6. The device of claim 1, wherein the processor is configured to increment a result counter based on a comparison of at least a portion of the second plurality of intensity difference values received during the second time period and a second threshold, and wherein the processor is further configured to generate the assay result output based at least in part on the result counter.

7. The device of claim 1, further comprising:

a pair of electrical contacts separated by a gap and in physical contact with the lateral flow diagnostic strip, wherein the gap, when wetted by the fluid sample, causes a current to flow between the pair of electrical contacts; and

a current detection circuit configured to;

sense the current between the pair of electrical contacts; and

increase a level of power supplied to the processor.

8. The device of claim 7, wherein the first time period is after the level of power supplied to the processor is increased.

9. The device of claim 1, wherein the first time period is between five seconds and twenty-eight seconds.

10. The device of claim 1, wherein the processor is configured to exclude the intensity difference values obtained during the first time period when generating an assay result output.

11. The device of claim 7, wherein the processor is further configured to:

increment a fluid front counter based on a comparison between the threshold and an intensity difference value obtained during the first time period;

determine, prior to the end of the first time period, that the fluid front counter exceeds a count threshold associated with a presence of the fluid front; and

in response to said determining that the fluid front counter exceeds the count threshold, disable at least one element included in the device at least until the end of the first time period.