Systems, methods, and test kits for analyte variation detection

• US 9,939,385 B2
• Filed: 09/09/2011
• Issued: 04/10/2018
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Church & Dwight Company Incorporated
• Inventors: Nazareth, Albert, Sturman, Andy, Zin, Benedict, Cheng, Yea-Shun, Bell, Henry, Li, Shang
• Primary Examiner(s): Brown, Melanie Yu
• Application Number:
  US13/229,156
• Publication Number:
  US 20130065321A1
• Time in Patent Office: 2,405 Days
• Field of Search: 436 65, 436500, 436814, 436817, 436906
• 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

Abstract

Systems, methods, and test kits for monitoring and detecting variation in an analyte level in a fluid sample from an individual variation using a uniquely determined analyte threshold value. In one implementation, luteinizing hormone is the monitored analyte and is compared with the determined threshold value to predict the onset of ovulation for the individual.

Claims

1. A method of using a test strip reader to detect a variation in a monitored analyte level in a fluid sample from an individual, the method comprising:

(i) contacting the fluid sample from the individual with a test strip associated with the test strip reader, wherein the test strip reader is configured to receive a plurality of test strips and wherein the test strip reader comprises one or more sensors;

(ii) detecting, via the one or more sensors, an analyte concentration within the test strip reader to generate a sample value;

(iii) storing the sample value;

(iv) repeating steps (i)-(iii) a corresponding series of times using the plurality of test strips over a plurality of days during a single biological cycle of the individual to generate a plurality of stored sample values;

(v) generating a set of baseline values from the plurality of stored sample values via processing circuitry in the test strip reader, wherein the processing circuitry determines the set of baseline values by discarding a sample value that is identified as an outlier, and substituting the discarded sample value with a constant or with a later acquired sample value, wherein the set of baseline values is generated from fluid samples obtained during the first three days or any one or more of the third through tenth days from onset of menses of a menstrual cycle of the individual;

(vi) generating, via the processing circuitry, a personal threshold level associated with the monitored analyte level for the individual based at least in part on the set of baseline values;

(vii) generating via the one or more sensors a signal representative of the monitored analyte level in one or more samples in the series;

(viii) comparing via the processing circuitry the signal to the personal threshold level; and

(ix) generating an output based at least in part on a result of the comparing.

2. The method of claim 1, wherein the monitored analyte is a hormone or hormone metabolite.

3. The method of claim 1, wherein the monitored analyte is selected from a group comprising follicle stimulating hormone, thyroid stimulating hormone, luteinizing hormone, human chorionic gonadotropin, estrogen, progesterone, testosterone, or metabolites thereof.

4. The method of claim 1, wherein the fluid sample is urine.

5. The method of claim 1, wherein generating a signal representative of the monitored analyte level comprises analyzing a test strip.

6. The method of claim 1, wherein the signal representative of the monitored analyte level comprises a photometric or an electroactive signal.

7. The method of claim 1, wherein the set of baseline values is generated from at least some fluid samples obtained on any one or more of the third through the tenth day from the onset of menses of a menstrual cycle of the individual.

8. The method of claim 1, wherein the set of baseline values is generated from fluid samples obtained after cessation of menses of a menstrual cycle of the individual.

9. The method of claim 1, wherein the threshold is an average of the set of baseline values times a surge factor.

10. The method of claim 9, wherein the surge factor is three.

11. The method of claim 1, wherein the threshold is greater than an average of the set of baseline values.

12. The method of claim 1, wherein the threshold is less than an average of the set of baseline values.

13. The method of claim 1, wherein the set of baseline values is derived from monitored analyte level data from a biological cycle in which the variation is to be detected.

14. The method of claim 13, wherein the variation indicates an onset of a menstrual cycle ovulatory phase for the individual.

15. The method of claim 13, wherein the monitored analyte is luteinizing hormone.

16. The method of claim 13, wherein the monitored analyte is progesterone.

17. The method of claim 1, wherein comparing the signal comprises comparing the signal to a configurable signal range.

18. The method of claim 1, further comprising disabling the test strip reader based at least in part on the result.