SYSTEMS, METHODS, AND TEST KITS FOR ANALYTE VARIATION DETECTION

• US 20130065321A1
• Filed: 09/09/2011
• Published: 03/14/2013
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• Current Assignee: Church & Dwight Company Incorporated
• Original Assignee: Church & Dwight Company Incorporated
• Inventors: Sturman, Andy, Zin, Benedict, Cheng, Yea-Shun, Bell, Henry, Li, Shang, NAZARETH, Albert
• Granted Patent: US 9,939,385 B2
• Time in Patent Office: Days
• US Class Current: 436/500
• 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 detecting a variation in a monitored analyte level in a fluid sample from an individual, the method comprising:

collecting a series of samples over a single biological cycle of the individual;

determining a baseline from a plurality of samples in the series;

determining a threshold associated with the monitored analyte level for the individual based at least in part on the determined baseline;

generating a signal representative of the monitored analyte level in one or more samples in the series;

comparing the signal to the threshold; and

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 threshold 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 baseline 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 a plurality of monitored analyte measurements times a multiplication factor.

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

11. The method of claim 1, wherein the threshold is greater than the baseline.

12. The method of claim 1, wherein the threshold is less than the baseline.

13. The method of claim 1, wherein the baseline 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 15, wherein luteinizing hormone levels greater than or equal to the threshold predicts the onset of ovulation for the individual.

17. The method of claim 1, wherein the variation of the monitored analyte indicates an onset of menopause for the individual.

18. The method of claim 17, wherein menopause is characterized as one of natural menopause, perimenopause, induced menopause, premature menopause, or post menopause.

19. The method of claim 1, wherein the variation of the monitored analyte indicates an abnormal pregnancy for the individual.

20. The method of claim 19, wherein the abnormal pregnancy is a failed implantation or an ectopic pregnancy.

21. The method of claim 19, wherein the monitored analyte is progesterone.

22. The method of claim 21, wherein progesterone levels greater than or equal to the threshold indicates a normal pregnancy for the individual.

23. The method of claim 21, wherein progesterone levels less than the threshold indicates an abnormal pregnancy for the individual.

24. The method of claim 1, wherein the variation of the monitored analyte indicates ovarian reserve for the individual.

25. The method of claim 24, wherein the monitored analyte is follicle stimulating hormone.

26. The method of claim 1, wherein a measured value is replaced with a configurable constant when the monitored analyte level data is less than or equal to a configurable reference value.

27. The method of claim 1, wherein determining a threshold comprises generating a signal if a sample from the plurality of samples varies from a configurable exaggerated threshold.

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

29. The method of claim 1, comprising disabling the detecting.

30. The method of claim 29, wherein the disabling is based at least in part on a result of the comparing.

31. The method of claim 29, wherein the disabling is based at least in part on a number of samples collected.

32. A device for detecting a variation in a monitored analyte level in a fluid sample from an individual, the device comprising:

means for collecting a series of samples over a single biological cycle of the individual;

means for determining a baseline from a plurality of samples in the series;

means for determining a threshold associated with the monitored analyte level for the individual based at least in part on the determined baseline;

means for generating a signal representative of the monitored analyte level in one or more samples in the series;

means for comparing the signal to the threshold; and

means for generating an output signal in response to the means for comparing.

33. The device of claim 32, wherein the means for collecting a series of samples comprises a plurality of test strips.

34. The device of claim 32, wherein the means for determining a baseline comprises a baseline analysis circuit.

35. The device of claim 34, wherein the baseline analysis circuit comprises a photodetector.

36. The device of claim 32, wherein the means for determining a threshold comprises a threshold conversion circuit.

37. The device of claim 32, wherein the means for generating a signal representative of the monitored analyte level comprises a photodetector.

38. The device of claim 32, where the means for comparing the signal with the threshold comprises a comparator circuit.

39. The device of claim 32, comprising a display configured to present the output signal to a user.

40. A test kit for detecting a variation in a monitored analyte level in a fluid sample from an individual, the test kit comprising:

disposable test sticks; and

a reader, the reader comprising;

a port for accepting a test stick therein; and

a circuit configured to;

determine a baseline from a plurality of initial samples in a series of samples collected with a series of test sticks;

determine a threshold associated with the monitored analyte level for the individual based at least in part on the determined baseline;

generate a signal representative of the monitored analyte level in one or more samples in the series collected subsequent to the initial samples;

compare the signal to the threshold; and

generate an output signal based at least in part on the result of the comparing.

41. The test kit of claim 40, wherein the test sticks comprise test strips.

42. The test kit of claim 40, wherein the reader comprises an optical sensor.

43. The test kit of claim 40, wherein the threshold is an average of a plurality of monitored analyte measurement values times a multiplication factor.

44. The test kit of claim 43, wherein the multiplication factor is three.

45. The test kit of claim 40, wherein the threshold is approximately three times the baseline.

46. The test kit of claim 40, wherein the plurality of initial samples consists of three samples.