Test methods, devices and test kits

• US 7,044,919 B1
• Filed: 04/02/1999
• Issued: 05/16/2006
• Est. Priority Date: 04/02/1998
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Catt, Michael, May, Keith, McNae, Fiona, Phelan, Andrew P, Habeshaw, Rosie L
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/285,060
• Time in Patent Office: 2,601 Days
• Field of Search: 600/551, 436/65
• US Class Current: 600/551
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: G01N 33/743 Steroid hormones
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors

Abstract

A method for determining the time of maximum fertility in the mammalian ovulation cycle, for the purpose of assisting conception, wherein testing is conducted over a period of days in the current ovulation cycle on samples of body fluid obtained from an individual human subject to detect an elevated concentration of first analyte, such as luteinising hormone (LH) indicative of the event of ovulation, and additionally testing is conducted over a period of days in the current ovulation cycle on samples of body fluid obtained from the individual subject to detect an elevated concentration of a second analyte, such as estradiol or a metabolite thereof, especially estradiol-3-glucuronide (E3G), to provide advance warning of ovulation.

Claims

1. A monitoring device for use in conjunction with one or more body fluid testing devices to provide an indication of the time of maximum fertility in the mammalian ovulation cycle, said monitoring device comprising:

a) a reading means for reading for reading test signals provided by said one or more testing devices, said reading means being operationally connected to said testing devices, said signals including a signal proportional to the concentration of a first analyte in a body fluid, which first analyte exhibits a detectable concentration change at about the time of ovulation in said cycle, and a signal proportional to the concentration of a second analyte in a sample of body fluid, which second analyte exhibits a detectable concentration change after the commencement of said cycle but before the concentration change of said first analyte becomes detectable; and

b) an electronic processing means for interpreting said test signals obtained in a series of tests conducted following the commencement of said cycle, wherein said electronic processing means of said monitoring device is operationally connected to said reading means, said electronic processing means providing an indication that fertility is elevated when said concentration change of said second analyte has been detected, and an indication that fertility is maximum when said concentration change of said first analyte has been detected.

2. A monitoring device according to claim 1 wherein said first analyte is luteinising hormone (LH).

3. A monitoring device according to claim 1 wherein said second analyte is selected from the group consisting of estradiol and metabolites thereof.

4. A monitoring device according the claim 3 wherein said second analyte is estrone-3-glucuronide (E3G).

5. A monitoring device according to claim 1 wherein said body fluid is urine.

6. A monitoring device according to claim 1 wherein said mammalian ovulation cycle is the human ovulation cycle.

7. A monitoring device according to claim 1 wherein no indication of maximum fertility is provided unless said concentration change of said second analyte has already been detected in the current cycle or is detected no later than the time at which said concentration change of said first analyte is detected.

8. A monitoring device according to claim 1 further comprising a receiving means for receiving said signals from said one or more testing devices said receiving means providing said test signals to said reading means, and a display means for providing said indications of fertility.

9. A monitoring device according to claim 8, wherein said display means includes a visual indication in the form of a bar or similar symbol the height or length of which is altered in either a continuous or step-wise manner as the likelihood of conception increases, attaining a maximum height or length to indicate the most appropriate time in the cycle to attempt conception.

10. A monitoring device according to claim 1 including interface means for communicating with transmitting means for transmitting electronic data.

11. A monitoring device according to claim 10, wherein said transmitting means is a semi-conductor memory device.

12. A test kit comprising a monitoring device according to claim 1 together with at least one body fluid testing device to provide said readable test signals.

13. A test kit comprising a monitoring device according to claim 1 together with a plurality of body fluid testing devices to provide said readable test signals.

14. A test kit according to claim 13 wherein each of said testing devices provides a test signal proportional to said concentration of said first analyte and a test signal proportional to said concentration of said second analyte.

15. A test kit according to 14 wherein each of said test devices uses a single sample of said body fluid.

16. A test kit according to claim 15 wherein said ovulation cycle is the human ovulation cycle, said body fluid is urine, said first analyte is LH and said second analyte is E3G.

17. A method for determining the time of maximum fertility in the human ovulation cycle comprising obtaining samples of body fluid of a human subject, conducting testing over a period of days in the current ovulation cycle on said samples of body fluid to detect an elevated concentration of luteinising hormone (LH) indicative of the event of ovulation and conducting additional testing over a period of days in the current ovulation cycle on additional samples of body fluid obtained from the individual human subject to detect an elevated concentration of an analyte selected form the group consisting of estradiol and metabolites thereof indicative of the imminent event of ovulation.

18. A method according to claim 17, wherein an analyte selected from the group consisting of estradiol and metabolites thereof are detected in the same body fluid samples as is used in the LH tests.

19. A method according to claim 17, or claim 18, wherein an elevated LH concentration apparently indicative of the event of ovulation is disregarded unless an elevated concentration of an analyte selected from the group consisting of estradiol and metabolites thereof has already been detected in the current cycle or is detected concurrently with the elevated LH concentration.

20. A method according to claims 17, or claim 18, wherein a single test is used to determine both LH and said analyte selected from the group consisting of estradiol and metabolites thereof in a single body fluid sample.

21. A test kit for use in a method according to claim 17 comprising:

a) at least one body fluid testing device that provides a readable signal proportional to the concentration of LH in a sample of said body fluid;

b) at least one body fluid testing device that provides a readable signal proportional to the concentration of said analyte selected from the group consisting of estradiol and metabolites thereof in a sample of said body fluid;

c) an electronic monitor having reading means for reading said readable signals and incorporating computer means for interpreting said readable signals and to determine therefrom in conjunction with data from previous body fluid tests whether the event of ovulation in the current cycle is about to occur or has just occurred.

22. A test kit according to claim 21, comprising a plurality or testing devices each of which provides a readable signal proportional to said LH concentration and a readable signal proportional to said estradiol/metabolite concentration in a single sample of the body fluid.

23. A test kit according to claim 21, wherein the electronic monitor includes interface means for communicating with a transmitting means for transmitting electronic data.

24. A test kit according to claim 23, wherein said transmitting means is selected from the group consisting of a smart card and a floppy disk.

25. A test kit according to claim 23, wherein said transmitting means is a semi-conductor memory device.

26. A method of patient management comprising testing a patient by analysis of a body fluid of said patient, wherein said analysis is accomplished by:

(i) providing;

a) one or more testing devices that provide test signals, including a signal proportional to the concentration of a first analyte in a body fluid, which first analyte exhibits a detectable concentration change at about the time of ovulation in said cycle, and a signal proportional to the concentration of a second analyte in a sample of body fluid, which second analyte exhibits a detectable concentration change after the commencement of said cycle but before the concentration change of said first analyte becomes detectable;

b) a monitoring device comprising receiving means for receiving one of said one or more testing devices, reading means associated with said receiving means for reading said test signals, electronic processing means for interpreting said test signals, and interface means for communicating with electronic data transmission means; and

c) electronic data transmission means for transmitting electronic data;

(ii) downloading electronic data from said monitoring device onto said electronic data transmission means;

(iii) inputting said downloaded electronic data into said electronic processing means, from which said electronic processing means a health professional thereby derives patient-related information.

27. A method according to claim 26, wherein said electronic data transmission means is a semi-conductor memory device.

28. A method according to claim 26 wherein said first analyte is luteinising hormone (LH).

29. A method according to claim 26 wherein said second analyte is selected from the group consisting of estradiol and metabolites thereof.

30. A method according to claim 29 wherein said second analyte is estrone-3-glucuronide (E3G).

31. A method according to claim 26 wherein said body fluid is urine.

32. A method according to claim 26 wherein said mammalian ovulation cycle is the human ovulation cycle.

33. A method according to claim 26, wherein in response to test signals provided by said one or more testing devices used in a series of tests conducted following the commencement of said cycle, said monitoring device provides an indication that fertility is elevated when said concentration change of said second analyte has been detected, and an indication that fertility is maximum when said concentration change of said first analyte has been detected.

34. A method according to claim 33 wherein no indication of maximum fertility is provided unless said concentration change of said second analyte has already been detected in the current cycle or is detected no later than the time at which said concentration change of said first analyte is detected.

35. A method according to claim 26, wherein said monitoring device includes display means for providing an indication of fertility, said display means including a visual indication in the form of a bar or similar symbol the height or length of which is altered in either a continuous or step-wise manner as the likelihood of conception increases, attaining a maximum height or length to indicate the most appropriate time in the cycle to attempt conception.

36. A method according to claim 26 wherein each of said testing devices provides a test signal proportional to said concentration of said first analyte and a test signal proportional to said concentration of said second analyte.

37. A method according to claim 36 wherein each of said test devices uses a single sample of said body fluid.

38. A method according to claim 26 wherein said ovulation cycle is the human ovulation cycle, said body fluid is urine, said first analyte is LH and said second analyte is E3G.

39. A method according to claim 26 for determining the time of maximum fertility in the mammalian ovulation cycle, wherein testing is conducted over a period of days in the current ovulation cycle on samples of body fluid to detect a change in the concentration of an analyte indicative of the actual event of ovulation and wherein testing is conducted over a period of days in the current ovulation cycle on samples of body fluid to detect a change in the concentration of an analyte indicative of the imminent event of ovulation.

40. A method according to claim 26 for determining the time of maximum fertility in the human ovulation cycle, wherein testing is conducted over a period of days in the current ovulation cycle on samples of body fluid obtained from an individual human subject to detect an elevated concentration of luteinising hormone (LH) indicative of the event of ovulation, wherein additional testing is conducted over a period of days in the current ovulation cycle on samples of body fluid obtained from the individual human subject to detect an elevated concentration of an analyte selected from the group consisting of estradiol and metabolites thereof indicative of the imminent event of ovulation.

41. A method according to claim 40, wherein an analyte selected from the group consisting of estradiol and metabolites thereof are detected in the same body fluid samples as are used in the LH tests.

42. A method according to claim 40 or claim 41 wherein an elevated LH concentration apparently indicative of the event of ovulation is disregarded unless an elevated concentration of an analyte selected from the group consisting of estradiol and metabolites thereof has already been detected in the current cycle or is detected concurrently with the elevated LH concentration.

43. A method according to claim 40 or claim 41, wherein a single test is used to determine both LH and said an analyte selected from the group consisting of estradiol and metabolites thereof in a single body fluid sample.

44. A method according to claim 26, wherein said electronic data transmission means is selected from the group consisting of a smart card and a floppy disk.

45. A method according to claim 26, wherein said electronic data transmission means is interfaced with said monitor to record an event occurring during an ovulation cycle.

46. A method according to claim 45, wherein said event is an act of intercourse.

47. A method according to claim 45, wherein said event is the occurrence of a physiological symptom.

48. A method according to claim 26, wherein said electronic data transmission means is interfaced with said monitoring device to download a result of a specific test for which a specific testing device is provided.

49. A method according to claim 48, wherein said specific test is a test for an analyte selected from the group consisting of human chorionic gonadotrophin (hCG), pregnanediol-3-glucuronide (P3G) and follicle stimulating hormone (FSH).