Methods and kit for endometriosis diagnosis

• US 8,841,130 B2
• Filed: 07/11/2012
• Issued: 09/23/2014
• Est. Priority Date: 07/11/2011
• Status: Active Grant

• Current Assignee: Diagnostrix AS
• Original Assignee: Oratel Diagnostics, LLC
• Inventors: Goldman, Dorothee
• Primary Examiner(s): Wallenhorst, Maureen
• Application Number:
  US13/546,280
• Publication Number:
  US 20130017614A1
• Time in Patent Office: 804 Days
• Field of Search: 436/63, 436/86, 436/103, 436/93, 436/164, 436/166
• US Class Current: 436/63
• CPC Class Codes: G01N 2800/364 Endometriosis, i.e. non-malignant disorder in which functioning endometrial tissue is present outside the uterine cavity
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10T 436/142222 Hetero-O [e.g., ascorbic acid, etc.]
• CPC Class Codes: Y10T 436/16 Phosphorus containing

Abstract

An endometriosis diagnostic in which a biological sample of a female mammal having had a menstrual cycle within 90 days of the biological sample having been obtained from the female mammal is subjected to an in vitro diagnostic procedure in which the biological sample is contacted with an apatite compound for an effective time to provide a responsive visual appearance. Based on the visual appearance, a determination is made whether the female mammal has endometriosis.

Claims

1. An endometriosis screening method, comprising:

contacting in vitro saliva with an apatite compound for an effective time to provide a responsive visual appearance, wherein the saliva is from a female mammal that experienced an ovulatory menstrual cycle within a period of 90 days leading up to a date on which the saliva was obtained, and further wherein the date on which the saliva was obtained within the 90-day period was not 24 to 36 hours before the female mammal experienced a luteinizing hormone surge consistent with ovulation; and

observing the responsive visual appearance and providing a screening result as to whether the female mammal has endometriosis based on the responsive visual appearance, wherein the screening result is that the female mammal does not have endometriosis if the responsive visual appearance is clear and non-cloudy to an unaided human eye, and wherein the screening result is that the female mammal has endometriosis if the responsive visual appearance is cloudy to the unaided human eye.

2. The endometriosis screening method of claim 1, wherein the female mammal is human.

3. The endometriosis screening method of claim 1, wherein the apatite compound comprises hydroxyapatite.

4. The endometriosis screening method of claim 1, wherein the female mammal is human and the apatite compound comprises hydroxyapatite.

5. An endometriosis screening method, comprising contacting in vitro saliva obtained from a female mammal during the luteal phase of a menstrual cycle with an apatite compound, a flavonol pigment, and an anthocyanin pigment for an effective time to produce a color response, and providing a screening result as to whether the female mammal has endometriosis based on the color response, wherein the color response corresponding to the screening result is affected by the anthocyanin pigment.

6. The endometriosis screening method of claim 5, wherein the screening result is that the female mammal does not have endometriosis if the color response is pink, and wherein the screening result is that the female mammal has endometriosis if the color response is blue.

7. The endometriosis screening method of claim 5, wherein the female mammal is human.

8. The endometriosis screening method of claim 5, wherein the flavonol pigment comprises quercetin.

9. The endometriosis screening method of claim 5, wherein the anthocyanin pigment has a three-position carbon with a first O-glycosyl group and a five-position carbon with a second O-glycosyl group.

10. The endometriosis screening method of claim 5, wherein the anthocyanin pigment comprises a member selected from the group consisting of cyanidin 3,5-diglycoside, petunidin 3,5-diglycoside, hirsutidin 3,5-diglycoside, pelargonidin 3,5-diglycoside, and malvidin 3,5-diglycoside.

11. The endometriosis screening method of claim 5, wherein the apatite compound comprises hydroxyapatite.

12. The endometriosis screening method of claim 5, wherein the female mammal is human and wherein the apatite compound comprises hydroxyapatite.

13. An endometriosis screening method, comprising contacting in vitro saliva obtained from a female mammal during the luteal phase of a menstrual cycle with an apatite compound, quercetin, and malvidin 3,5-diglucoside for an effective time to produce a color response, and providing a screening result as to whether the female mammal has endometriosis based on the color response, wherein the screening result is that the female mammal does not have endometriosis if the color response is pink, and wherein the screening result is that the female mammal has endometriosis if the color response is blue.

14. The endometriosis screening of claim 13, wherein the female mammal is human.

15. The endometriosis screening method of claim 13, wherein the apatite compound comprises hydroxyapatite.

16. The endometriosis screening method of claim 13, wherein the female mammal is human and the apatite compound comprises hydroxyapatite.