AU1453001A - Personal pregnancy testing kit - Google Patents

Description

WO 01/33222 PCT/USOO/30117 PERSONAL PREGNANCY TESTING KIT FIELD OF THE INVENTION The present invention relates in general to personal pregnancy testing kits that determine whether a woman is pregnant by testing the woman's saliva. The kit tests for 5 the presence of elevated levels of one or more hormones, which are produced by the woman following conception, such as Beta "HCG," estrogen, or progestrogen in the woman's saliva by testing for the enzyme marker related to that hormone in the saliva. The present invention also relates to the packaging for storing the enzyme-sensitive pads of a personal pregnancy testing kit and to the method for testing the woman's saliva to 10 determine whether she is pregnant. The invention is also applicable to the storage of the hormone-sensitive pads which must be protected from any contact with ultraviolet light, moisture, or air. BACKGROUND OF THE INVENTION There are personal test kits that are widely available for determining whether a 15 woman is pregnant, before there are any noticeable physical signs of pregnancy. These tests are designed to test for the presence of certain hormones in the woman's urine. Upon the detection of the particular hormone, the test strip will change to a particular color, which indicates to the user that she is pregnant. If no hormones are detected, there will not be any color change, or a change to a different color. 20 These personal pregnancy tests, although effective for their intended purpose, can be improved. For instance, the hormones that these tests are intended to detect cannot be detected with the necessary accuracy using the urine tests until approximately one month after actual conception. The one month delay from conception until detection provides a disadvantage in that the pregnant woman who does not know that she is pregnant cannot 25 enjoy early doctor intervention and cannot modify her behavior in accordance with her pregnancy. There thus exists the need for a personal pregnancy test that can detect that a woman in pregnant as soon as possible after conception and that has the benefits of the urine test in that it can be easily and safely performed at home by the woman. The kit 30 should also be self-contained, that is, all the necessary items, including instructions and WO 01/33222 PCT/USOO/30117 any charts or graphs, should be included within or on the packaging. The test kit should also be easy to administer -- easy enough so that any one can use the test kit without any specialized training. A testing kit that is able to detect one or more hormones, or other pregnancy 5 markers, by testing for enzymes the user's saliva may be capable of meeting these needs. For example, it is known that a person's saliva contains certain enzymes which are markers indicating that certain materials may also be present in the person's blood. One example of the testing of a person's saliva is the determination of a.person's blood alcohol level. A person's saliva contains the same concentration of alcohol as in that 10 person's blood. Test kits have been developed for detecting the level of a person's blood alcohol in that person's saliva. These test kits utilize alcohol-sensitive pads that are formed from paper saturated with alcohol oxidase enzyme, alcohol peroxidase enzyme, dyes and a buffer. When these alcohol-sensitive pads are saturated with a person's saliva, they will change color according to the level of alcohol in that saliva. Such a personal 15 blood alcohol testing kit is disclosed in U.S. Patent No. 5,563,073. Accordingly, there exists a need fora personal testing kit to detect the presence of elevated levels of certain pregnancy-indicating hormones by testing the person's saliva. SUMMARY OF THE INVENTION In accordance with the present invention, a personal pregnancy testing kit that is 20 capable of determining whether a woman is pregnant is provided. The test kit determines whether certain hormones are present by analyzing the woman's saliva, rather than their urine. The test kit is comprised of the packaging and the pad or pads that are stored within the packaging. The pads are chemically sensitive to elevated levels of certain 25 predetermined hormones contained in the saliva, such as Beta "HCG," estrogen, or progesterone, and are preferably impregnated with at least one enzyme that is sensitive to the particular enzyme marker related to the hormone that it is searching for, at least one dye, and at least one buffer. The pads change color when it is contacted with the user's saliva, but only if the user's saliva contains the particular enzyme related to the hormone WO 01/33222 PCT/USOO/30117 for which the pad is intended to test. This change in color indicates that the woman's saliva contains this particular hormone's enzyme, and thus the test will reveal by this change in color that the woman is pregnant. The test kit of the present invention provides the benefit that it is capable of 5 detecting whether the woman is pregnant as early as five (5) to seven (7) days after conception. This is because the hormone-sensitive pads of the present invention are capable of testing for enzymes indicating the presence of such hormones as Beta "HCG" at concentrations from five (5) units an greater. Elevated levels of Beta "HCG" that are detectable by the hormone-sensitive pads are produced by the body within five to seven 10 days after conception. These hormones are not detectable by the urine tests that are currently being used. Instead, those tests look for elevated levels of certain other hormones. The elevated levels of these hormones that are necessary for detection by the urine tests do not appear until the woman has missed her period, which could occur within a minimum of 30 days after conception. 15 Each enzyme -sensitive pad comprises a piece of paper saturated with one or more enzymes that are sensitive to an enzyme related to the hormone that is being tested. The paper is also saturated with dyes and a buffer. The enzyme-sensitive pads are preferably cut into small pieces less than one-half square inch in size. The enzyme-sensitive pads are attached to the end of a stick so that the user may place the enzyme-sensitive pad 20 within her mouth to saturate the pad with saliva or may dip the enzyme-sensitive pad into saliva that has been collected in a cup. The enzyme-sensitive pads are stored in a package. The package includes a first side wall comprised of a plurality of layers coupled together with at least one of the layers being formed from aluminum foil and a second side wall also comprised of a plurality of 25 layers coupled together with at least one of the layers being formed from aluminum foil. The aluminum foil of the first and second side walls of the package may be formed from high-grade surgical aluminum foil. Similarly, the aluminum foil may coated with a polymer. In either case, the package is formed by coupling together the outer edge of the first side wall with the outer edge of the second side wall to form an interior for storing at 3 WO 01/33222 PCTUSOO/30117 least one hormone-sensitive pad. The package is intended to protect the enzyme-sensitive pads from ultraviolet light, moisture, and air. The instructions for use may be printed on the outside surface of one of the side walls of the packaging. Thus, by printing the instructions for use on the exterior of the 5 package, a self-contained personal pregnancy testing kit is provided. The user performs the personal pregnancy test after abstaining from eating or drinking for at least fifteen minutes prior to taking the test. The test is administered by saturating the enzyme-sensitive pad or pads at the end of the stick with the user's saliva. Once the pad or pads are completely saturated, the user waits approximately two minutes 10 for the hormone-sensitive pad or pads to change color. If any of the pads changes color, this indicates the presence of the hormone for which that particular pad is testing. If there is no change in color, then that hormone is not present. Thus, an easy-to-administer test is provided that is accurate and reproducible and does not require the taking of urine. Other objects, features and advantages of the invention will become apparent from 15 a consideration of the following detailed description and from the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top plan view of the package for storing the hormone-sensitive pads of a personal pregnancy testing kit showing a plurality of the hormone-sensitive pads and 20 sticks with which one embodiment of the present invention can be used; FIG. 2 is a side cross-sectional view taken along the line 2-2 in FIG. 1 containing four sticks with pads; and FIG. 3 is a top elevational view of the exterior of the package showing the instructions for use and color changes printed thereon with which one embodiment of the 25 present invention can be used. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is embodied in a personal pregnancy testing kit for testing the presence of any one of a number of enzyme markers in the user's saliva related to 4 WO 01/33222 PCT/USOO/30117 pregnancy hormones in a user and includes the enzyme-sensitive pads and the packaging for storing the enzyme-sensitive pads. In the particular embodiment shown in the drawings and herein described, the personal pregnancy testing kit 10 (see FIGS. 1 and 2) comprises at least one enzyme 5 sensitive pad 12 that is attached to a stick 14. The sticks 14 and pads 12 are stored within a package 16. The enzyme-sensitive pads 12 may include one or more enzymes. These enzymes are sensitive to ultraviolet light, moisture, and air and will lose their activity if exposed to these elements for any substantial amount of time. Accordingly, these pads need to be stored in a package which prevents their exposure to these elements. 10 Each enzyme-sensitive pad 12 is designed so that, when exposed to a person's saliva, the pads 12 are capable of detecting the presence of an enzyme marker for a predetermined hormone. If the enzyme for the hormone that the pad is designed to detect is in fact detected, buffers and dyes, that are also present on the enzyme-sensitive pad 12, are activated so that they will cause a change in color of the pad 12. The user can then 15 examine the change in color and determine whether they are pregnant. At least one enzyme-sensitive pad' 12 is provided within the interior 18 of the package 16. (FIGS. 1 and 2). The enzyme-sensitive pads 12 are preferably formed from a piece of paper saturated with one or more enzymes, one or more dyes, and one or more buffers. Each enzyme-sensitive pad is designed to be sensitive to the enzyme marker for 20 a particular, specific hormone. In other words, the pad may be sensitive to enzyme marker for the hormone Beta "HCG." Thus, this pad would be saturated with the enzyme or enzymes that are sensitive to the enzyme marker for Beta "HCG" that will be present in a person's saliva when the person is pregnant and elevated levels of this hormone are found in the person's bloodstream. One benefit to this method of detection of the enzyme 25 marker for Beta "HCG" is that the enzyme pads can detect concentrations of Beta "HCG" as low as five (5) units and greater. In addition, this pad 12 should further include one or more dyes and buffers which will cause a change in color when the Bets "HCG"-sensitive enzyme or enzymes are activated by the Beta "HCG" marker in the saliva. Any enzyme. dye, and buffer, or combination thereof, may be selected, so long as the enzyme, dye, and 30 buffer combination are capable of detecting the presence of the marker for Beta "HCG" in 5 WO 01/33222 PCT/USOO/30117 the person's saliva, and, when such marker is detected, are capable of causing the hormone-sensitive pad to change color. The use of an enzyme in the pad that is sensitive to the marker found in saliva for Beta "HCG" is merely exemplary -- any enzyme may be chosen so long as it is capable of detecting the marker for elevated levels of a hormone in 5 the user's saliva that indicates that the user is pregnant. Examples of other such hormones are estrogen and progestrogen. The fact that the test kit of the present invention is capable of detecting the presence of elevated levels of hormones, such as Beta "HCG" provides the benefit that it is capable of detecting whether the woman is pregnant as early as five (5) to seven (7) 10 days after conception. Elevated levels of Beta "HCG" that are detectable by the hormone-sensitive pads are produced by the body within five to seven days -after conception. These hormones are not detectable by the urine tests that are currently being used. Instead, those tests look for elevated levels of certain hormones. The elevated levels of these hormones that are necessary for detection by the urine tests do not appear 15 until the woman has missed her period, which could occur within a minimum of 30 days after conception. The enzyme-sensitive pads 12 are preferably mounted by any adhesive well known in the art to one end of a thin plastic stick 14. (See FIGS. 1 and 2). Any type of plastic that can be formed into thin flexible sticks that is well-known in the art may be 20 used to form stick 14. The stick 14 is preferably as wide as the enzyme-sensitive pad 12 and long enough so that the user can place the enzyme-sensitive pad within his mouth without placing the user's hand into the user's mouth. Additionally, the stick may be formed from any other substantially rigid and inert material, such as wood or metal, if desired. 25 Each enzyme-sensitive pad 12 is cut into small pieces and are rectangularly shaped, preferably being one quarter inch long by three-eighths inches wide. If desired, the pads 12 may be cut into any shape so long as the pad will fit onto the end portion of the stick 14 that can be easily inserted into the user's mouth and saturated with saliva. The end of the stick 14 that contains the pads may be wider than the remainder of the 6 WO 01/33222 PCT/USOO/30117 stick that does not contain the pads 12 to make it clear to the user which portion of the stick 14 should be saturated with the saliva. The enzymes that are used on the pads 12 are sensitive to exposure to ultraviolet light, moisture, and air and will lose their activity if they are exposed to any of these 5 elements for an appreciable amount of time. Thus, the package 16 of the present invention is particularly suited for storing the enzyme-sensitive pads 12 of the testing kit 10 without exposing them to ultraviolet light, moisture, or air. The package 16 preferably comprises a first side wall 22 and a second side wall 24. Both the first and second side walls (22 and 24, respectively) preferably comprise an inner and outer layer, (26 and 28, 10 respectively, for the first side wall and 30 and 32, respectively, for the second side wall). The inner layer 26 of the first side wall 22 and the inner layer 30 of the second side-wall 24 is preferably formed from aluminum foil. The aluminum foil used is preferably a high grade surgical aluminum foil. It has been found that the high grade surgical aluminum foil is preferred over other types of 15 aluminum foils because this type of aluminum foil does not give off any oils that could damage the hormone-sensitive pads during prolonged storage times. Conventional aluminum foils that are typically used in packaging may give off the oils and residues that are imparted to the aluminum foil during manufacture when exposed to elevated temperatures, such as room temperature and the temperatures found when stored in a 20 warehouse or on an automobile dashboard. For this reason, high grade surgical aluminum foil may be chosen instead. High grade surgical aluminum foil differs from conventional aluminum foil in that it is specially washed during manufacture to remove the impurities normally found in conventional aluminum foil. Thus, the term high grade surgical aluminum foil is used herein to describe aluminum foil that is in a condition wherein it is 25 free from impurities such as oils and other foreign matter. The use of the high grade surgical aluminum foil therefore provides the distinct benefit of allowing the hormone sensitive pads 12 of the present invention to be stored within a package 16, without exposing the pads 12 to ultraviolet light, moisture, air, or any other impurities. Further, the packaging provides the additional benefit that the pads 12 do not have to be stored 7 WO 01/33222 PCT/USOO/30117 under refrigerated conditions, but, rather can be stored at room temperature, or even in a warehouse or on the dashboard of a car. In the alternative, the inner layers 26, 30 of the first and second side walls 22 and 24 of the packaging 16 may comprise conventional aluminum foil which has been coated 5 on at least one surface with a polymer. If the surface of the aluminum foil having the polymer is utilized as the inner layer of the side walls that contacts the hormone-sensitive pads, then the polymer coating will prevent the oils of the conventional aluminum foil from coming into contact with the hormone-sensitive pads that are located within the package. Any polymer and any means for coating the conventional aluminum foil known 10 in the art may be used, so long as the foil/polymer combination are capable of providing a packaging which prevents the hormone-sensitive pads from coming into contact -with ultraviolet light, moisture, or air. The outer layer 28 of the first side wall 22 and the outer layer 32 of the second side wall 24 are preferably formed from paper. By providing a first and second side wall, 15 22 and 24, that are formed from paper and aluminum, the first and second side walls of the package 28, 32, are easily opened by tearing by the user. Although paper is preferred as the outer layer of the first and second side walls, 22, 24, any material may be used that will provide a carrier for the aluminum foil that comprises the inner layer 26, 30 of the side walls 22, 24 and provide the benefit of preventing exposure of the enzyme-sensitive 20 pads contained within the packaging to ultraviolet light, moisture, and any other impurities. As shown in FIG. 2, the first side wall 22 is formed by coupling together the surface 34 of the layer 28 of the first side wall 22 with the surface 36 of the inner laver 26 of the first side wall 22. When coupled together, the outer edge 38 of the outer layer 28 is 25 preferably contiguous with the outer edge 40 of the inner layer 26. Any type of adhesive material that is well-known in the art for coupling aluminum foil to paper may be used for coupling together these two layers. The second side wall 24 is formed by coupling together the surface 42 of the inner layer 30 of the second side wall 24 with the surface 44 of the outer layer 32 of the second side wall 24. When coupled together, the outer edge 8 WO 01/33222 PCT/USOO/30117 46 of inner layer 30 is preferably contiguous with the outer edge 48 of the outer layer 32. Again, any adhesive well-known in the art may be used for coupling these layers together. The package 16 for storing the enzyme-sensitive pads of the personal pregnancy testing kit 10 of the present invention is then preferably formed by coupling together the 5 outer edge 40 of the inner layer 26 of the first side wall 22 with the outer edge 46 of the inner layer 30 of the second side wall 24 to form an interior 18 for storing at least one enzyme-sensitive pad 12. (See FIG. 2). The inner layer 26 of the first side wall 22 and the inner layer 30 of the second side wall 24, which are both preferably fopned from high grade surgical aluminum, are facing each other and form the inside lining of the interior 10 18 of the package 16. When the first side wall 22 and the second side wall 24 are coupled together, the enzyme-sensitive pads 12, which are attached to sticks 14, are placed between the two side walls in a vacuum environment so that the enzyme-sensitive pads do not contact any air when they are placed into the package 16 or when they are stored in the interior 18 of 15 the package 16. Thus, the enzyme-sensitive pads 12 of the testing kit 10 are maintained within an environment in which their only contact is with the inner layer 26 of the first side wall 22 and the inner layer 30 of the second side wall 24, both preferably formed from the high grade surgical aluminum foil. The exterior of the package 16 that is exposed to ultraviolet light, moisture and air, are the outer layer 28 of the first side wall 20 22 and the outer layer 30 of the second side wall 32, which are formed from paper. The package 16, having the high grade surgical aluminum foil interior (or polymer coated aluminum interior) and paper exterior is able to store the enzyme-sensitive pads 12 of the testing kit in its interior 18 without exposing the enzyme-sensitive pads 12 to any ultraviolet light, moisture or air. 25 The instructions for administering the pregnancy test may also be printed on the exterior 50 of the package 16 along with the location of the particular pads, as described above. By printing the instructions and the location of the pads, a self-contained personal blood test is provided, that is, the entire test is contained within and on the packaging. The hormone-sensitive pads 12 are designed to change color if the marker for the 30 desired hormone is detected in the user's saliva. Thus. if the hormone marker is detected. 9 WO 01/33222 PCT/USOO/30117 the pad 12 will change color and the test will be positive for pregnancy. The dye and, therefore, the color change may be shaped as a "plus" sign as shown in Fig. 3. If no hormone marker is detected, there will be no change in color and the test for pregnancy is negative. Thus, after application of the saliva, if there is a color change, the user can very 5 easily compare the color changes of the pad 12 and compare it with color change indicated on the exterior 50 of the packaging 16. The user would therefore be capable of easily and quickly determining the results of the test. The user preferably performs the pregnancy test as follows. First.he user should abstain from eating or drinking for at least 15 minutes prior to taking the test. The user 10 then opens the package 16 by tearing open the first and second side walls, 22 and 24, respectively, to reveal the enzyme-sensitive pads 12 and sticks 14 within the interior 18. The user then preferably saturates the enzyme-sensitive pads 12 with the user's saliva, preferably by either placing the enzyme-sensitive pad end of the stick 14 into the mouth and saturating the enzyme-sensitive pad 12 with saliva. The user may also place their 15 saliva in a cup and saturate the enzyme-sensitive pad 12 in the saliva. The user then preferably waits approximately two minutes for the enzyme-sensitive pad 12 to become activated and change color, if the presence of the hormone being tested is detected. The user then compares the color change of the hormone-sensitive pad 12, if any, with the color that is printed on the exterior 50 of the package 16. If no color change is detected, 20 then the test is negative for pregnancy. If the pad 12 changes color, then the user is pregnant. Thus, as can be seen, the test is easy to administer and does not require the testing of urine by the user. Further, it can be seen that the test is self-contained and requires no other outside parts other than the user's saliva to perform. In a further preferred embodiment of the present invention, the first and second 25 side walls 22 and 24 respectively, are rectangularly shaped. It is preferable that the package containing the personal pregnancy testing kit be portable so that it can be discreetly carried in a wallet, pocket or purse. Thus, one size for making the first and second side walls 22, 24 is a size approximating that of a business card, which are commonly held within a wallet. This size is preferably rectangular, being three and a half 30 inches long by two inches wide. 10 WO 01/33222 PCT/USOO/30117 In another embodiment of the present invention, the first side wall 22 further comprises a plastic covering layer 52 coupled together with the upper surface 54 of the outer layer 28 of the first side wall 22. (See FIG. 2). The plastic covering layer 52 may also be coupled to the lower surface 56 of the outer layer 32 of the second side wall 24 5 (Not shown in FIG. 2). The plastic covering layer 52 is substantially rigid to protect the hormone-sensitive pads 12 and sticks 14 contained within the package 16 from any bending that may occur while the package is stored within a wallet, pocket or purse of the user. The plastic covering layer is preferably formed from any plastic that can be formed into thin, substantially rigid sheets that can be imprinted with color printing. 10 While a particular form of the invention has been illustrated and described, it will be apparent that various modifications can be made without departing from the scope of the invention. For instance, the size and shape of the first and second side walls 22, 24 may be chosen as preferred by the manufacturer in any size and shape so long as the sticks 14 and the hormone-sensitive pads 12 are contained within the interior of the 15 package. Accordingly, it is not intended that the invention be limited by the specific embodiment disclosed in the drawings and described in detail hereinabove. 11

Claims (29)

1. A personal pregnancy testing kit, comprising: at least one pad being chemically sensitive to a predetermined hormone; and a package, the pads being stored within the package.

2. The personal pregnancy testing kit of claim 1 further including at least one stick having an end wherein the pad is attached to the end of the stick and wherein the stick is stored within the package.

3. The personal pregnancy testing kit of claim 1 wherein the pad is formed from paper and is impregnated with at least one enzyme that is sensitive to the predetermined hormone, at least one dye and at least one buffer, wherein when the hormone-sensitive enzyme comes in contact with the user's saliva, the dye changes color 5 only if the predetermined hormone is present in elevated amounts in the system of the user.

4. The personal pregnancy testing kit of claim I wherein the package has an exterior having the instructions for use of the personal pregnancy testing kit printed thereon.

5. The personal pregnancy testing kit of claim 1, wherein the predetermined hormone is selected from the group comprising: Beta "HCG", estrogen, and progestrogen.

6. The personal pregnancy testing kit of claim 1, wherein the package has an exterior surface and an interior surface and wherein the interior surface comprises aluminum foil.

7. The personal pregnancy testing kit of claim 6, wherein the aluminum foil is high-grade surgical aluminum foil.

8. The personal pregnancy testing kit of claim 6, wherein the aluminum foil is coated with a polymer. 12 WO 01/33222 PCT/USOO/30117

9. A personal pregnancy testing kit, comprising: at least one pad being chemically sensitive to a predetermined hormone; and a package having an interior being formed from high grade surgical aluminum foil, the pads being stored within the package.

10. The personal pregnancy testing kit of claim 9 further including at least one stick having an end wherein the pad is attached to the end of the stick and wherein the stick is stored within the package.

11. The personal pregnancy testing kit of claim 9 wherein there exterior of the package comprises paper.

12. The personal pregnancy testing kit of claim 9 wherein the pad is formed from paper and is impregnated with at least one enzyme that is sensitive to the predetermined hormone, at least one dye and at least one buffer, wherein when the hormone sensitive enzyme comes in contact with the user's saliva, the dye changes color 5 only if the predetermined hormone is present in elevated amounts in the system of the user.

13. The personal pregnancy testing kit of claim 9 wherein the package has an exterior having the instructions for use of the personal pregnancy testing kit printed thereon.

14. The personal pregnancy testing kit of claim 9 wherein the package has an enclosed interior, the enclosed interior containing substantially no air.

15. The personal pregnancy testing kit of claim 8, wherein the predetermined hormone is selected from the group comprising: Beta "HCG", estrogen, and progestrogen.

16. A personal pregnancy testing kit, comprising: at least one pad being chemically sensitive to the predetermined hormone, the pad being formed from paper and being impregnated with at least one hormone-sensitive 13 WO 01/33222 PCT/USOO/30117 Docket No enzyme, at least one dye and at least one buffer, wherein when the hormone-sensitive 5 enzyme comes in contact with the user's saliva, the dye changes color; and a package for storing the pad, the package being formed from paper and high grade surgical aluminum foil.

17. The personal pregnancy testing kit of claim 16 wherein the package includes: a first side wall having an outer edge and being comprised of a plurality of layers coupled together, at least one of the layers being formed from aluminum foJl; and 5 a second side wall having an outer edge and being comprised of a plurality of layers coupled together, at least one layer being formed from aluminum foil, wherein the outer edge of the first side wall is coupled together with the outer edge of the second side wall to form an interior for storing at least one hormone-sensitive pad.

18. The personal pregnancy testing kit of claim 15 further including at least one stick having an end wherein the hormone-sensitive pad is attached to the end of the stick and wherein the stick is stored within the interior of the package.

19. The personal pregnancy testing kit of claim 17 wherein one of the layers of the first side wall is a substantially rigid plastic layer.

20. The personal pregnancy testing kit of claim 17 wherein one of the layers of the first side wall is printed with the instructions for use of the pregnancy testing kit.

21. The personal pregnancy testing kit of claim 17 wherein at least one of the layers of the first side wall and at least one of the layers of the second side wall are formed from paper.

22. The personal pregnancy testing kit of claim 17 wherein the aluminum foil layer of the first side wall and the aluminum foil layer of the second side wall comprises a high grade surgical aluminum foil. 14 WO 01/33222 PCTUSOO/30117

23. The personal pregnancy testing kit of claim 17 wherein the aluminum foil layer of the first side wall and the aluminum foil layer of the second side wall is coated with a polymer.

24. The personal pregnancy testing kit of claim 16 wherein the interior of the package contains substantially no air.

25. The personal pregnancy testing kit of claim 16, wherein the predetermined hormone is selected from the group comprising: Beta "HCG", estrogen, and progestrogen.

26. A method for determining whether a woman is pregnant, comprising: opening a package comprising aluminum foil and containing at least one pad being chemically sensitive to a predetermined hormone; saturating one of the pads with the user's saliva; and 5 waiting approximately two minutes to determine whether the pad has detected the presence of the hormone by changing its color.

27. The method of claim 26 wherein the package comprises a high grade surgical aluminum foil.

28. The method of claim 26 wherein the aluminum foil of the package is coated with a polymer.

29. The personal pregnancy testing kit of claim 26, wherein the predetermined hormone is selected from the group comprising: Beta "HCG". estrogen, and progestrogen. 15