METHODS FOR PREDICTING THE ONSET OF MENARCHE

• US 20100105071A1
• Filed: 02/27/2008
• Published: 04/29/2010
• Est. Priority Date: 02/28/2007
• Status: Abandoned Application

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Feldman, Henry, Laufer, Marc
• Application Number:
  US12/528,814
• Publication Number:
  US 20100105071A1
• Time in Patent Office: Days
• US Class Current: 435/7.100
• CPC Class Codes: G01N 2800/361 Menstrual abnormalities or abnormal uterine bleeding, e.g. dysmenorrhea
• CPC Class Codes: G01N 2800/60 Complex ways of combining multiple protein biomarkers for diagnosis
• CPC Class Codes: G01N 33/743 Steroid hormones

Abstract

Embodiments of the invention provide methods for predicting the onset of menarche, i.e. a females first menstrual period, through the measurement of salivary hormone levels (e.g. 17-β estradiol, testosterone, progesterone, and/or 17 hydroxy-progesterone (17-OHP)). In particular, the methods described herein enable a reliable determination that menarche will, or will not occur, within varied time intervals, e.g. 1 to 30 days, 1 to 45 days, 1 to 60 days and 1 to 90 days. Diagnostic kits and products of manufacture comprising the kits are also provided.

Claims

1-59. -59. (canceled)

60. A device for predicting that menarche is anticipated in a human female within a known time interval comprising a solid support and at least one antibody against at least one hormone in a body fluid, wherein the hormone is selected from the group consisting of testosterone, 17-beta estradiol, progesterone, 17-hydroxyprogesterone, and wherein said antibody is on the solid support.

61. The device of claim 60, wherein the hormones testosterone and 17-hydroxyprogesterone are selected.

62. The device of claim 60, wherein the hormones testosterone, 17-beta estradiol and progesterone are selected.

63. The device of claim 60, wherein the hormones testosterone, 17-beta estradiol and 17-hydroxyprogesterone are selected.

64. The device of claim 60, wherein the hormones progesterone, 17-beta estradiol and 17-hydroxyprogesterone are selected.

65. The device of claim 60, wherein the hormones testosterone, 17-beta estradiol, 17-hydroxyprogesterone, progesterone and are selected.

66. The device of claim 60, wherein said antibody is immobilized on the solid support.

67. The device of claim 60, wherein said antibody is of a defined quantity just enough to bind the hormone when the hormone is at a threshold level.

68. The device of claim 67, wherein the threshold level is selected from the group consisting of:

a range between 0.01-0.05 nanograms per milliliter for testosterone, a range between 0.5-10.0 picograms per milliliter for 17-beta estradiol, a range between 0.01-0.05 nanograms per milliliter for progesterone, and a range between 0.01-0.10 nanograms per milliliter for 17-hydroxyprogesterone.

69. The device of claim 60, wherein said antibody is in excess of an amount just enough to bind the hormone when the hormone is at a threshold level.

70. The device of claim 69, wherein the threshold level is selected from the group consisting of:

a range between 0.01-0.05 nanograms per milliliter for testosterone, a range between 0.5-10.0 picograms per milliliter for 17-beta estradiol, a range between 0.01-0.05 nanograms per milliliter for progesterone, and a range between 0.01-0.10 nanograms per milliliter for 17-hydroxyprogesterone.

71. The device of claim 60, wherein the antibody produces a detectable signal.

72. The device of claim 60, wherein said antibody is conjugated to colloidal gold beads or latex beads.

73. The device of claim 60, further comprising a second antibody against a hormone in a body fluid, wherein the hormone is selected from the group consisting of testosterone, 17-beta estradiol, progesterone, 17-hydroxyprogesterone, and wherein said second antibody is on the solid support.

74. The device of claim 60, wherein the body fluid is selected from a group consisting of saliva, tears, urine, sweat, blood plasma, or vaginal secretion.

75. The device of claim 60, wherein the device performs an immunoassay wherein an antibody-hormone complex is formed.

76. The device of claim 60, wherein the device is a dip stick or a test-strip.

77. The device of claim 60, wherein said time interval is between 1 to 60 days.

78. The device of claim 60, wherein said time interval is between 1 to 90 days.

79. The device of claim 60, wherein said time interval is between 1 to 30 days.

80. The device of claim 60, wherein said time interval is between 1 to 45 days.