Electronic analyte assaying device

• US 8,828,329 B2
• Filed: 12/14/2010
• Issued: 09/09/2014
• Est. Priority Date: 10/01/2010
• Status: Active Grant

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Church & Dwight Company Incorporated
• Inventors: Sturman, Andy, Zin, Benedict, Nazareth, Albert, Bell, Henry
• Primary Examiner(s): Xu, Robert
• Application Number:
  US12/967,971
• Publication Number:
  US 20120083044A1
• Time in Patent Office: 1,365 Days
• Field of Search: None
• US Class Current: 422/402
• CPC Class Codes: G01N 21/17 Systems in which incident light is modified in accordance with the properties of the material investigated where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63
• 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 2201/062 LED's
• CPC Class Codes: G01N 2201/12 Circuits of general importance; Signal processing
• CPC Class Codes: G01N 2333/59 Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G01N 33/493 urine
• CPC Class Codes: G01N 33/62 involving urea
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors

Abstract

An improved electronic diagnostic device for detecting the presence of an analyte in a fluid sample comprises a casing having a display, a test strip mounted in the casing, a processor mounted in the casing, and a first sensor mounted in the casing and operatively coupled to the processor. The processor is configured to receive a signal from the first sensor when the device is exposed to ambient light thereby causing the device to become activated. The device includes a light shield that exerts pressure across a width of the test strip to prevent fluid channeling along the length of the test strip. The processor is configured to present an early positive test result reading when a measured value exceeds a predetermined early reading threshold value at any time after a predetermined early testing time period.

Claims

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

a casing having a display;

a test strip mounted in said casing;

a battery mounted in said casing;

a processor mounted in said casing coupled to said battery;

a light source mounted in said casing and operatively coupled to said processor, said light source configured to illuminate a portion of said test strip;

a first sensor mounted inside said casing coupled to said battery and operatively coupled to said processor; and

an opening in said casing through which the first sensor can receive ambient light;

wherein said processor is configured to receive a signal from said first sensor when said device is exposed to ambient light thereby causing said device to become activated.

2. The device of claim 1, wherein when said device is activated, said device performs a self-diagnostic test to ensure that the device is operating within pre-established parameters.

3. The device of claim 1, further comprising a second sensor mounted in said casing and operatively coupled to said processor, said second sensor being positioned to sense an area corresponding to a test result site on said test strip.

4. The device of claim 3, further comprising a third sensor mounted in said casing and operatively coupled to said processor, said third sensor being positioned to sense an area adjacent to the test result site on said test strip.

5. The device of claim 4, wherein said processor is configured to:

receive a signal from said second and third sensors; and

perform a comparison of said second sensor signal reading with said third sensor signal reading,

wherein said comparison further comprises calculating a difference value by subtracting one of said second signal reading and said third signal reading from the other of said second signal reading and said third signal reading.

6. The device of claim 5, wherein said processor is configured to confirm the detection of a valid fluid front when said difference value exceeds a predetermined valid fluid front threshold value.

7. The device of claim 5, wherein said processor is configured to display a positive test result message on said display if said difference value is greater than an early positive result threshold value at any time after a predetermined time period from the detection of a valid fluid front.

8. The device of claim 7, wherein said predetermined time period is less than a standard time period.

9. The device of claim 8, wherein said predetermined time period is approximately 90 seconds.

10. The device of claim 5, wherein said processor is configured to display within a predetermined time period from the detection of a valid fluid front

a positive test result message on said display if said difference value exceeds a predetermined threshold value, and

a negative test result message on said display if said difference value is less than said predetermined threshold value.

11. The device of claim 10, wherein said predetermined time period is approximately 3 minutes.

12. The device of claim 1, further comprising a light shield mounted in said casing, wherein said light shield is configured to apply pressure across a width of said test strip to inhibit uneven channeling of fluid flow along a length of said test strip.

13. The device of claim 4, further comprising a light shield mounted in said casing, wherein said light shield is configured to apply pressure across a width of said test strip to prevent channeling of fluid, said light shield further comprising:

a first through hole configured to direct light from said light source onto a portion of said test strip; and

a second through hole configured to direct reflected light from said portion of said test strip to said second sensor and said third sensor.

14. The device of claim 1, further comprising a sample receiving member coupled to said test strip at a first end for receiving a fluid sample on said test strip.

15. The device of claim 3, wherein said light source is a light emitting diode;

and wherein said first and said second sensors are photo sensors.

16. The device of claim 1, wherein said display is mounted on a first side of said casing and said first sensor is mounted on a second side of said casing, said second side being opposite to said first side.

17. The device of claim 1, wherein said casing is elongated.

18. The device of claim 5, wherein said processor is programmed with a normal test result time, a normal test result threshold, an early test result time, and an early test result threshold, wherein said processor is configured to provide a positive result message if the difference value exceeds the early test result threshold after the early test result time and before the normal test result time, or if the difference value exceeds the normal test result threshold at the normal test result time.

19. The device of claim 18, wherein the early test result threshold is greater than the normal test result threshold.