Method for evaluating estrogen dependent physiological conditions

• US 5,922,613 A
• Filed: 09/22/1997
• Issued: 07/13/1999
• Est. Priority Date: 03/23/1995
• Status: Expired due to Term

• Current Assignee: Oratel Diagnostics, LLC
• Original Assignee: Dorothee E.F. Goldman
• Inventors: Goldman, Dorothee E. F.
• Primary Examiner(s): Chin, Christopher L.
• Assistant Examiner(s): Phan, Quang N.
• Application Number:
  US08/913,758
• Time in Patent Office: 659 Days
• Field of Search: 435/805, 435/806, 435/970, 436/63, 436/65, 436/64, 436/164, 436/169, 436/817, 436/906
• US Class Current: 436/169
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G01N 33/743 Steroid hormones
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/806 Fertility tests
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/817 Steroids or hormones
• CPC Class Codes: Y10S 436/906 Fertility tests

Abstract

A method and apparatus for evaluating estrogen dependent physiological conditions includes a substrate having an anthocyanin pigment applied thereto. The pigment yields a color response indicative of how the body fluid responds to changes in its capacity to absorb free estrogens. The pigment is contacted by the body fluid sample, and the response thereto is connected through color response or optical density measurements to predetermined physiological conditions.

Claims

1. Method for screening for endometriosis, comprising the steps of:

a) originating with a female human a saliva sample;

b) providing an anthocyanin 3,5-diglucoside pigment at a concentration of between about 8×

10^-5 M and 1×

10^-3 M at a pH of between about 5.0 and 7.5 responsive to the capacity of the saliva sample to change its free estrogen solubility level;

c) contacting the pigment with the saliva sample and permitting a color response to occur; and

d) detecting from the color response of the pigment whether there are imbalances in how the saliva sample responds to changes in its capacity to absorb free estrogen and thereby screening for endometriosis.

2. Method of claim 1, wherein detecting the color response through one of visual perception, optical density determination, and chromatography.

3. Method of claim 2, including the step of:

a) providing a color chart having at least two preselected colors, one color indicative of whether the saliva sample has achieved its maximal capacity to absorb free estrogen; and

b) evaluating the color response of the pigment by comparison with the color chart.

4. Method of claim 3, wherein the anthocyanin pigment is selected so as to generate a blue color response to the saliva sample having achieved maximum capacity to absorb free estrogen.

5. Method of claim 2, wherein the color response is detectd by optical measurement, the optical density determination being performed between 500 nm and 620 nm.

6. Method of claim 1, wherein the pigment on the substrate is at a concentration between about 5×

10^-5 M to 1×

10^-3 M.

7. Method of claim 1, wherein the saliva sample is at a temperature of less than 100°

F.

8. Method of claim 1, including the steps of:

adding a known amount of extrogen to the saliva sample after step 6; and

repeating step c in order to determine how much of said estrogen must be added to the saliva sample in order to determine the maximum sensitivity for estrogen absorption of the saliva sample.

9. Method of claim 8, wherein the estrogen is estradiol.

10. Method of claim 8, wherein the estrogen is 17 beta estradiol.

11. Method of claim 1, wherein the pigment is malvidin 3,5 diglucoside, petunidin 3,5 diglucoside, cyanidin 3,5 diglucoside, or pelegordinin 3,5 diglucoside.

12. Method of claim 1, wherein the pigment has the following general formula:

##STR4## wherein R₁ is selected from the group consisting of hydrogen, hydroxy, and C₁ -C₄ alkoxy;

R₂ is selected from the group consisting of hydrogen, hydroxy, and C₁ -C₄ alkoxy;

R₃ is a glycoside selected from the group consisting of glucosides, rutinosides, arabinosides, sophorosides, p-cuomaroyl, rutinosides, and rhamnosides; and

R₅ is a glycoside selected from the group consisting of glucosides, and X⁺ is a cation.

13. Method of claim 1, wherein a substrate is provided allowing solid phase contact between the saliva sample and the pigment and the substrate is formed from a material selected from the group consisting of transparent glass strip, acetate, polyethylene, acrylic, and cellulose.

14. Method of claim 1, wherein components having a size in excess of 10,000 Daltons are filtered from the saliva sample prior to contact with the pigment.

15. Method of claim 14, wherein the filtering of the saliva sample is performed using a wick formed from the group consisting of cotton, cellulose, absorbent materials, and molecular sieves.

16. Method of claim 1, wherein applying a metal salt with the pigment prior to contacting the pigment with the saliva sample.

17. Method of claim 16, wherein the metal salt is calcium chloride.

18. The method of claim 1, further comprising the step of:

e) repeating steps b through d of claim 1 with a plurality of saliva samples taken over a selected time interval.

19. The method of claim 18, wherein the saliva samples are taken over a period of at least five days, with at least one sample being taken each day.

20. The method of claim 19, further including the step of:

f) recording each color response.

21. Method for indicating parturition, comprising the steps of:

a) originating with a female mammal a saliva sample;

b) providing an anthocyanin 3,5 diglucoside pigment at a concentration of from about 8×

10^-5 M to about 1×

10^-3 M at a pH of between 5.0 and 7.5 responsive to the capacity of the saliva sample to change its free estrogen solubility level;

c) contacting the pigment with the saliva sample and permitting a color response to occur; and

d) detecting from the color response of the pigment whether the body fluid has achieved its capacity to absorb free estrogen and thereby screening for an indication that parturition may be imminent.

22. Method for indicating synchrony during embryo implantation, comprising the steps of:

a) originating a plurality of saliva samples, each sample taken from a different female mammal;

b) contacting each saliva sample with an anthocyanin 3,5 diglucoside pigment at a concentration of from about 8×

10^-5 M to about 1×

10^-3 M at a pH of between 5.0 and 7.5 responsive to the capacity of the saliva samples to change their free estrogen solubility levels so that a color response occurs; and

c) evaluating the color response of each saliva sample that has been contacted with the anthocyanin pigment and thereby monitoring for synchrony in color responses between at least two of the female mammals.