Home ovulation test kit and method

• US 5,211,182 A
• Filed: 10/23/1991
• Issued: 05/18/1993
• Est. Priority Date: 10/23/1991
• Status: Expired due to Fees

• Current Assignee: Marshall E. Deutsch, Stephen M. Blinn
• Original Assignee: Marshall E. Deutsch, Stephen M. Blinn
• Inventors: Blinn, Stephen M., Deutsch, Marshall E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/781,842
• Time in Patent Office: 573 Days
• Field of Search: 128/760, 128/762, 128/771, 128/738, 206/569, 206/570, 604/317, 604/318
• US Class Current: 600/584
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004

Abstract

A testing kit and method for determining the day of ovulation in a woman who has menstruated having a plurality of test assemblies each with an upper chamber, a lower chamber in fluid communication with the upper chamber separated from the upper chamber by a screen member, a saliva-absorbable chewable plug which when chewed by the user can be compressed against the screen member to express saliva into the lower chamber which contains a reagent which produces a color change, the intensity of which is proportional to the concentration of glucose in the saliva wherein a plurality of such test assemblies are utilized one on each of successive days for determination of the peak color intensity on the day that the saliva has the greatest concentration of glucose to allow for computation from this peak day of the date of ovulation of the woman.

Claims

1. A test array for viewing and making colorimetric determinations of a scheduled series of reactions comprising:

an array of test assemblies, each test assembly including;

an upper chamber;

a lower chamber in fluid communication with said upper chamber, said lower chamber having a predetermined cross-sectional length and cross-sectional width;

transparent window means in said lower chamber for unaided viewing of any contents thereof;

a screen member positioned between said upper chamber and said lower chamber;

a fluid-absorbable chewable plug member removably positioned within said upper chamber, said plug member absorbing such fluid as is to be colorimetrically evaluated;

means for compression of said plug member after absorbing fluid and when positioned within said upper chamber to express said fluid from said plug member through said screen member into said lower chamber; and

a reagent disposed in said lower chamber capable of producing a colored reaction product after admixture with any of said fluid expressed from said plug member, said colored reaction product being viewed unaided through said window means of said lower chamber when making a colorimetric determination,

said array of test assemblies providing a viewable range of colored reaction products of specific intensities correlatable with the scheduled series of reactions.

2. The test array of claim 1 wherein said test is for determining the day of peak ovulation of a woman;

wherein said fluid is saliva obtained from a woman chewing said chewable plug; and

wherein one of said test assemblies is utilized per day over a series of successive days.

3. The test array of claim 2 wherein a series of between three to eight test assemblies are utilized in said array, one each utilized on successive days and further wherein said reagent contains a glucose oxidase enzyme and a peroxidase which reagent, when saliva is added thereto, produces a color with the intensity of the color being proportional to the concentration of glucose in said saliva with the most intense color produced on the day of greatest glucose concentration in :

he saliva.

4. The test array of claim 3 wherein there is an excess of reagent sufficient to react with all of the glucose in said saliva, said reaction being independent of the amount of saliva deposited in said test assembly.

5. The test array of claim 4 wherein said means for viewing the contents of the lower chamber of each test assembly comprises a transparent window aligned with the cross-sectional length of said lower chamber to allow viewing of said reagent/saliva mixture through said entire cross-sectional length for color intensity comparison of the contents of said lower chamber of different test assemblies.

6. A test assembly for viewing and making a colorimetric determination comprising:

an upper chamber;

a lower chamber in fluid communication with said upper chamber, said lower chamber having a predetermined cross-sectional length and cross-sectional width;

transparent window means in said lower chamber for unaided viewing of any contents thereof;

a screen member disposed between said upper chamber and said lower chamber;

a fluid-absorbable chewable plug member removably positioned within said upper chamber, said plug member absorbing such fluid as is to be colorimetrically evaluated;

means for compression of said plug member after absorbing fluid and when positioned in said upper chamber to express said fluid from said plug member through said screen member into said lower chamber; and

a reagent disposed in said lower chamber capable of producing a colored reaction product after admixture with the fluid expressed from said plug member, said colored reaction product being viewed unaided through said window means of said lower chamber when making a colorimetric determination.

7. The test assembly of claim 6 wherein said fluid is saliva and said test assembly is used for testing glucose concentration in said saliva for determination of the day of ovulation in a woman who has menstruated.

8. The test assembly of claim 7 wherein the screen member between said upper and lower chambers retains said plug within said upper chamber while allowing the saliva to pass through the openings in said screen member to react with said reagent in said lower chamber.

9. The test assembly of claim 8 wherein there is an excess of reagent over the amount needed to react with all of the glucose in the saliva causing the entire amount of glucose to react with the reagent and produce a color change with the intensity of the color produced proportional to the concentration of glucose in the saliva, such color intensity visible through said transparent wall throughout the cross-sectional length of said lower chamber, said color intensity being unaffected by the amount of saliva in said lower chamber but controlled solely by the concentration of glucose in the saliva, creating a colorimetric determination test independent of the amount of saliva in said lower chamber.

10. The test assembly of claim 9 wherein said reagent further includes a gelling agent.

11. The test assembly of claim 10 wherein said plug member is chewed and absorbs saliva and wherein said plug member contains a sialagogue to promote salivation.

12. The test assembly of claim 11 further including means to allow air escape from said lower chamber as said saliva is being expressed through said screen member by said means for compression.

13. The test assembly of claim 12 wherein said lower chamber is generally rectangular in configuration and said upper chamber is of an open-topped cylindrical configuration.

14. A method for viewing and making a colorimetric determination comprising the steps of:

introducing fluid into a fluid-absorbable plug such that said fluid is releasably absorbed by said plug;

inserting said fluid-absorbed plug into a test assembly comprising;

an upper chamber,

a lower chamber in fluid communication with said upper chamber, said lower chamber having a predetermined cross-sectional length and cross-sectional width,

window means in said lower chamber for unaided viewing of any contents thereof,

a screen member positioned between said upper chamber and said lower chamber,

means for compression of said fluid-absorbed plug member within said upper chamber to express said fluid from said plug member through said screen into said lower chamber, and

a reagent disposed in said lower chamber capable of producing a colored reaction product after admixture with any of said fluid expressed from said plug member, said colored reaction product being viewed unaided through said window means of said lower chamber when making a colorimetric determination;

compressing said plug member against said screen member;

expressing the fluid from said plug member through said screen member into said lower chamber;

allowing said reagent in said lower chamber to react with said fluid to produce colored reaction product of a specific intensity; and

viewing the intensity of said colored reaction product through said window means of said lower chamber.

15. A method for determining the date of a woman'"'"'s ovulation by viewing and making a colorimetric determination over successive test days, said method comprising the steps of:

determining a first test day occurring one week after onset of the woman'"'"'s menstruation;

then

colorimetrically evaluating the glucose in the saliva of the woman said first test day and repeatedly on each of the successive test days thereafter by

(a) chewing a saliva-absorbing plug by the woman on each of said test days such that the woman'"'"'s saliva is releasably absorbed by said plug;

(b) inserting said saliva absorbed plug of each test day into an individual test assembly in an array of test assemblies, each test assembly of said array comprising;

an upper chamber;

a lower chamber in fluid communication with said upper chamber, said lower chamber having a predetermined cross-sectional length and cross-sectional width,

window means in said lower chamber for unaided viewing of any contents thereof,

a screen member positioned between said upper chamber and said lower chamber,

means for compression of said saliva absorbed plug within said upper chamber to express said saliva from said plug member through said screen member into said lower chamber,

a reagent disposed in said lower chamber capable of reacting with glucose in said saliva, said reagent having a concentration greater than the amount needed to react with all of said glucose to produce a colored reaction product whose intensity is proportional to the concentration of glucose in said saliva, the intensity of said colored reaction product being viewed unaided through said window means of said lower chamber when making a colorimetric determination,

(c) compressing said saliva absorbed plug of each test day against said screen member;

(d) expressing the saliva from said plug of each test day through said screen member into said lower chamber; and

(e) allowing said reagent in said lower chamber to react with said saliva of each test day to produce a colored reaction product of a specific intensity;

then

retaining said colored reaction product of each test assembly in said array for each of said test days;

viewing the intensity of each colored reaction product through said window means of said lower chamber in each test assembly in said array for each of said test days; and

comparing the color intensity of each colored reaction product in each test assembly in said array to determine which of said test days yielded the greatest concentration of glucose in the saliva and was the day of ovulation for the woman.

16. A testing kit for viewing and making a colorimetric determination of the day of ovulation in a woman who has menstruated, said testing kit comprising:

a base;

a plurality of test assemblies each for use on successive test days starting one week after the onset of menstruation, said test assemblies positioned on said base, each test assembly including;

an upper chamber;

a lower chamber in fluid communication with said upper chamber, said lower chamber of a predetermined cross-sectional length and cross-sectional width;

transparent window means in said lower chamber for unaided viewing of any contents thereof through said cross-sectional length;

a screen member disposed between said upper chamber and said lower chamber;

a saliva-absorbable chewable plug member removably positioned within said upper chamber, said plug member to be chewed by said woman;

means for compression of said plug member after absorbing saliva and when positioned within said upper chamber to express said saliva from said plug member through said screen member into said lower chamber; and

a reagent disposed in said lower chamber capable of producing a colored reaction product after admixture with the saliva expressed from said plug member, said colored reaction product being viewed unaided through said window means of said lower chamber when making a colorimetric determination, the amount of said reagent being in excess over the amount of glucose in said saliva to produce a colored reaction product wherein the intensity of the color produced is proportional to the concentration of glucose in the saliva,

said plurality of test assemblies providing a viewable range of colored reaction products of specific intensities by which to determine the day of ovulation.

17. The testing kit of claim 16 wherein said reagent further includes a gelling agent.

18. the testing kit of claim 16 wherein said plug member contains a sialagogue to promote salivation.

19. The testing kit of claim 16 further including means to allow air escape from said lower chamber as said saliva is being expressed through said screen member by said means for compression.

20. The testing kit of claim 16 wherein such color intensity visible through said transparent window means through said cross-sectional length of said lower chamber is unaffected by the amount of saliva expressed into said lower chamber but such color intensity is controlled solely by the concentration of glucose in said saliva, creating a colorimetric determination testing kit independent of the amount of saliva in said lower chamber wherein the user of said kit determines the date of ovulation based on computation from the date of greatest color intensity of the reagent/saliva mixture.