Article for detecting the fertile period and method for using same

• US 3,875,013 A
• Filed: 02/16/1973
• Issued: 04/01/1975
• Est. Priority Date: 02/16/1973
• Status: Expired due to Term

• Current Assignee: Adolfo Rosado Garcia, Jorge Martinez Manautou
• Original Assignee: Adolfo Rosado Garcia, Jorge Martinez Manautou
• Inventors: Manautou, Jorge Martinez, Garcia, Adolfo Rosado
• Primary Examiner(s): Tanenholtz, Alvin E.
• Application Number:
  US05/333,029
• Time in Patent Office: 774 Days
• Field of Search: 195/13.5R,13.5C
• US Class Current: 435/18
• CPC Class Codes: C12Q 1/34 involving hydrolase
• CPC Class Codes: C12Q 2334/10 p-Nitrophenol derivatives
• CPC Class Codes: G01N 2333/924 acting on glycosyl compounds (3.2)
• CPC Class Codes: Y10S 435/806 Fertility tests

Abstract

An article of manufacture and a test is provided for detecting the fertile period or the presence of pregnancy in the female. The article is comprised of a porous support impregnated with at least one color developing compound such as p-nitrophenyl-nacetyl- Beta -d-glucosaminide and at least one buffer that develops a color when contacted with a female biological medium. The development of the marked color is coincident with the fertile period, which indication of the fertile period can be used either for achieving fertilization or for preventing conception by the rhythmic method. Also, in the days preceding the expected menstrual period, the development of the marked color is coincident with the presence of pregnancy.

Claims

1. A TEST ARTICLE USEFUL FOR DETECTING AN INCREASE OF N-ACETYLB-GLUCOSAMINADASE IN A FEMALE BIOLOGICAL MEDIA WHICH IS COINCIDENT WITH THE ONSET OF THE FERTILE PERIOD OF A FEMALE, WHICH ARTICLE IS COMPRISED OF A BIBULOUS MATERIAL CONTAINING IMPREGNATED THEREIN A NON-TOXIC BUFFER CAPABLE OF MAINTINING THE PH IN THE RANGE OF 4 TO 5 AND AN EFFECTIVE AMOUNT OF THE COLOR INDICATOR P-NITROPHENYL-N-ACETYL-B-D-GLUCOSAMINIDE WHICH IN THE PRESENCE OF AN INCREASE OF N-ACETYL-BGLUCOSAMINADASE IN THE FEMALE BIOLOGICAL MEDIA FORMS A COLOUR DEVELOPING COMPOUND USEFUL FOR DETECTING THE FERTILE PERIOD.

2. A test article useful for detecting an increased N-acetyl-Beta -glucosaminadase activity according to claim 1 which additionally includes as a color intensifier a separate buffer capable of maintaining the pH in the range of 9 to 11.

3. A test article useful for detecting an increase of N-acetyl-Beta -glucosaminadase in a female biological media which is coincident with the presence of pregnancy in a female, which article is comprised of a bibulous absorbent strip-shaped material containing impregnated therein a non-toxic buffer capable of maintaining the pH in the range of 4 to 5 and an effective amount of a color indicator selecteD from the group of indicators consisting essentially of p-nitrophenyl-n-acetyl- Beta -d-glucosaminide, Alpha -naphthol-n-acetyl- Beta -d-glucosaminide, 1-(p-nitrocatechol)-n-acetyl- Beta -d-glucosaminide and 3,3-bis(p-hydroxyphenyl)phthalid-n-acetyl- Beta -d-glucosaminide which indicator in the presence of an increase of N-acetyl- Beta -glucosamindase in the female biological media forms a color developing compound wherein the color developed indicates the presence of pregnancy.

4. A diagnostic test for the detection of the fertile period of a female warm-blooded animal which test is comprised of adding a female media selected from the group consisting of saliva, cervical fluid and vaginal fluid to a composition consisting of the color indicator p-nitrophenyl-n-acetyl- Beta -d-glucosaminide in an amount sufficient to develop a color in the presence of N-acetyl- Beta -glucosaminadase in the media indicating fertility and ovulation and a biologically acceptable first buffer capable of maintaining the pH in the range of 4 to 5 to form a color developing compound, then adding a second buffer capable of maintaining the pH in the range of 9 to 11 to further develope the color which indicates the presence of said fertile period of the female.

5. A method for indicating when to use rhythmic contraception adapted to a female which method is comprised of determining the fertile period of the female by adding a female media selected from the group consisting of saliva, cervical mucosa and vaginal mucosa to a mixture consisting of the color indicator p-nitrophenyl-n-acetyl- Beta -d-glucosaminide present in an amount sufficient to develop a color in the presence of N-acetyl- Beta -glucosaminadase in the media and a biological acceptable buffer capable of maintaining the pH in the range of 4 to 5 to form a color developing compound, then adding a buffer capable of maintaining the pH in the range of 9 to 11 to further develop the color, which color indicates the fertile period that occurs during ovulation of the female which developed color is a means for determining when to use said method of rhythmic contraception.

6. A method for indicating the fertile period of the female that occurs during ovulation by detecting an increase in the enzyme N-acetyl- Beta -glucosamindase which is coincident with the fertile period of the female wherein the method is comprised of contacting female saliva containing the increase of N-acetyl-Beta -glucosamindase with the color indicator substrate p-nitrophenyl-n-acetyl- Beta -d-glucosaminide which is present in an effective amount to form the color developing compound p-nitrophenyl in the presence of a buffer capable of maintaining the pH in the range of 4 to 5, then adding another buffer capable of maintaining the pH in the range of 9 to 11 to further develop the color which color indicates the fertile period of the female.

7. A method for indicating the presence of pregnancy in a female by detecting an increase in the enzyme N-acetyl- Beta -glucosaminidase which is coincident with pregnancy, wherein the method is comprised of contacting a female fluid excretion with a composition containing the color indicator substrate p-nitrophenyl-n-acetyl- Beta -d-glucosaminide which is contained in the composition in an effective amount to form the color developing compound p-nitrophenyl in the presence of a buffer capable of maintaining the pH in the range of 4 to 5, then adding a buffer capable of maintaining the pH in the range of 9 to 11 to further develop the color which color indicates the presence of pregnancy in the female.

8. A test article useful for detecting an increase of N-acetyl-Beta -glucosaminadase in a female biological media which increase is coincident with the onset of the fertile period of a female, which article is comprised of a bibulous material containing impregnated therein a non-toxic buffer capable Of maintaining the pH in the range of 4 to 5 and an effective amount of the color indicator Alpha -naphthol-n-acetyl- Beta -d-glucosaminide which in the presence of an increase of N-acetyl- Beta -glucosaminadase in the female biological media forms a color developing compound useful for detecting the fertile period.

9. A test article useful for detecting an increase of N-acetyl-Beta -glucosaminadase in a female biological media which increase is coincident with the onset of the fertile period of a female, which article is comprised of a bibulous material containing impregnated therein a non-toxic buffer capable of maintaining the pH in the range of 4 to 5 and an effective amount of the color indicator 1-(p-nitrocatechol)-n-acetyl- Beta -d-glucosaminide which in the presence of an increase of N-acetyl- Beta -glucosaminadase in the female biological media forms a color developing compound useful for detecting the fertile period.

10. A test article useful for detecting an increase of N-acetyl-Beta -glucosaminadase in a female biological media which increase is coincident with the onset of the fertile period of a female, which article is comprised of a bibulous material containing impregnated therein a non-toxic buffer capable of maintaining the pH in the range of 4 to 5 and the color indicator 3,3-bis(p-hydroxyphenyl)-phthalid-n-acetyl- Beta -d-glucosaminide in an effective amount which in the presence of an increase of N-acetyl- Beta -glucosaminadase in the female biological media forms a color developing compound useful for detecting the fertile period.