KR20100098606A - A diagnostic device for identifying rupture of membrane during pregnancy - Google Patents

Abstract

The present invention relates to a diagnostic device for identifying amnion rupture during pregnancy, the support layer; Two reagent holding parts disposed on the support layer; And a dry reagent provided in the reagent holding unit, wherein the dry reagent is neither an enzyme nor an antibody, and performs a chemical reaction with creatinine, an alkaline phosphatase, or a protein contained in the vaginal secretion of a woman so as to visually distinguish amniotic fluid from urine. Cause

Description

A DIAGNOSTIC DEVICE FOR IDENTIFYING RUPTURE OF MEMBRANE DURING PREGNANCY}

The present invention relates to a diagnostic device for identifying amniotic rupture during pregnancy.

Different women have different moments of delivery and it is difficult to know the exact time of delivery. Childbirth is not an event but a comprehensive process of various physiological changes and events in the body. One such change or event is a tear in the amniotic membrane that surrounds the fetus in the womb, which is an indication of the imminent delivery. Amniotic rupture can occur suddenly and involves a large amount of amniotic fluid leakage. However, it is also common for pregnant women to be unaware of amniotic rupture.

If the amniotic fluid leak is not properly diagnosed in a timely manner, especially in high-risk pregnant women, poor treatment can pose a risk to the pregnant woman and the fetus. Leaking amniotic fluid can result in pain, infection, or premature birth, and very serious sequelae in both mothers and newborns.

Rapid, accurate and inexpensive instruments need to be used to greatly reduce the chance of overlooking amniotic rupture at home, and these instruments should also be available as a tool for doctors to test in hospitals.

Explain some things doctors can do now. The most widely used urine assay is to use a technique known as a "dip-and-read test strip" or "dipstick." This is an analysis band with chemical reagent attached to the reagent holding part. Generally, the strip itself consists of polymers such as polyethylene, polycarbonate, polystyrene and the like. Different reagent holding units are different. When the dipstick is immersed in the urine sample and taken out, a color reaction occurs as the reagent inside the urine sample comes into contact with it. Dipsticks are either designed as single pad test strips (for one material analysis) or multipad test bands (for testing multiple materials at once) and used either manually or in a suitable chemical analyzer. Test bands for analyzing multiple substances at once are introduced in US Pat. Nos. 4,595,439, 4,526,753, 4,160,008, 3,123,443, 3,212,855, 3,814,668, 4,038,485 and 3,531,254.

The reagent holding portion is usually an absorbent absorbing the liquid sample. As the liquid sample is absorbed by the capillary phenomenon, it comes into contact with the reagent, causing a color change that can be measured and detected. If the dipstick can measure several substances simultaneously, the color change at each reagent reservoir will be related to the amount of other substances in the liquid sample. Analyzing the results requires comparing the color change process on the dipstick to the color chart.

The reagent holder can be any material that can hold the reagent for the required analysis. Preferred reagent reservoirs are inert to the reagents and should not alter the sample or test results. The reagent holding part may be made of various materials such as fiber-containing paper such as filter paper, woven or nonwoven fabric, synthetic or modified natural polymer, sponge, cellulose, glass fiber, microporous membrane or wood. The fiber retaining portion may also differ in roughness and hardness. See US Patents 3,846,247, 3,552,928, 3,802,842, 3,418,083.

There are many instruments for analyzing urine using reagent holding parts (filter paper, microcapsules, dipsticks, etc.). The Jaffe reaction is a method of determining creatinine, which produces an orange-red color with an alkaline picric acid solution. Introduced in US Pat. No. 6,001,656 is a device for analyzing creatinine in a test solution, which uses quinoline to make reagents. Another creatinine reaction, published by Benedict and Behre in the Journal of Biological Chemistry in 1936, introduces the reaction of 3,5-ditrobenzene acid to creatinine in alkaline media. Other methods for determining creatinine in liquids such as urine are described in US Pat. Nos. 4,215,197 (using enzymes), 5,662,867 and 5,733,787. Suitable materials for detecting creatinine include picric acid, 3,5-dinitrobenzene acid, 3,4-dinitrobenzene acid, 2,4-dinitrobenzene sulfuric acid, (3,5-dinitrobenzyl) alcohol, (3 , 5-dinitrobenzo) -nitrile, (3,5-dinitrobenz) amide and N, N-diethyl- (3,5-dinitrobenz) amide. Other protein detection methods have also been reported.

These methods include the Biuret method, Lowry method, Kjeldahl method, pigment mixing method, fluorometric method and ultraviolet method. Among these methods, J. Lab. Clin. Med., 11, 981 (Mealmans Act, published in Kingbury-Clark Act Clin. Chim. Acta, 5, 757 (1960), published in 1926; Coomassie Brilliant, published in Anal Biochem. 72, 248 (1967)). The Blue method is widely used The protein assays described in US Pat. No. 4,023,933 are also widely used in almost all biochemical laboratories.In general, the proteins include CBB (coomassie brilliant blue), brominephenol blue (tetrabromophenol blue) and iosin Of course, it reacts with metal ions such as copper 2, lead 2, zinc 2, and silver monovalent, and adding a protein solution to the reaction between the dye and the metal ion causes a spectral change in the dye-metal ion solution. More protein indicators have been introduced in this series: Other protein indicators include Fast Green FCF, Light Green SF, Pyrogallol Sulfonphthalein (Pyrogallol Red), Pyrocatechol Sulfonphthalein (Pyrocatechol Violet), 3 ', 3 "-Dibromo-5 ', 5 "-dichlorophenolsulfonphthalein, fuxic acid, 2,4-dinitro-1-naphthol (Mathiose Yellow), copper, lead, zinc, silver, phloxine B, Congo red, ethyl orange or methyl There is an orange: The following list is a US patent that measures the protein in liquids such as urine using reagents used in the dipstick method: 5,424,215, 5,593,895, 6,815,210, 4,960,710, 3,485,587, 5,087,575, 4,023,933.

Urine tests for urobilinogens are also used in various dipsticks. Specific products include CHEMSTRIP and MULTISTIX. The classical urobililinogen assay, developed by Paul Ehrlich in 1901, uses paradimethylaminobenzaldehyde as a reagent that gives a brown-orange-red color in strong acids as a reagent. Examples of patents that test urobilinogens based on Ehrlich's reagent and diazonium binding reactions are U.S. Patents 3,853,466, 3,630,680, 4,665,038, 4,290,771, 3,989,462, 3,814,586. Related patents for measuring urobilinogen in urine using reagents from dipsticks are 4,158,546 and 3,447,905.

The initial alkaline phosphatase assay was introduced by Kay in the late 1930s and is widely used to measure alkaline phosphatase using p-nitrophenyl phosphate. This method is based on the fact that after exposure to a solution containing alkaline phosphatase the colorless p-nitrophenyl phosphatase turns into a yellow product, p-nitrophenol. Thus, the concentration of enzyme is determined by increasing the intensity of yellow color of the reaction product. Alkaline phosphatase is naturally present in milk, but denatures after pasteurization. Thus, alkaline phosphatase activity is used as an indicator for proper pasteurization of milk. This dry tester for alkaline phosphatase in milk is PHOSPHATESMO MI manufactured by MACHERY-NAGELT.

Janco's US patent 4,357,945 introduces a device with a pH indicator that changes color when the amniotic membrane ruptures and is exposed to amniotic fluid. Introduced in US Pat. No. 5,425,377 to Caillouett is equipped with a pH indicator that measures the pH of the vaginal fluid. U.S. Patent 5,554,504 examines growth factor binding proteins such as insulin in vaginal secretions. The kit, introduced in US Pat. No. 5,281,522 to Senyei, collects vaginal fluid from the vagina to detect rupture of the amniotic membrane. The method introduced in US Pat. No. 5,096,830 is to contact the vaginal fluid with an insoluble support to find amnion rupture.

There are also various known mechanisms related to panties and tampons that have a pH indicator. Introduced in US Pat. No. 6,149,590 is a pad with a pH response element in the middle of the upper and lower shells. The pads described in US Pat. Nos. 6,921,647 and 6,627,394 are equipped with pH indicators for detecting amniotic fluid. Introduced in US Pat. No. 5,217,444, the pH indicator in the absorber indicates the acidity or alkaline color change of the liquid in contact with it. Measuring pH of vaginal secretions only to distinguish amniotic fluid from urine is not accurate for the following reasons: 1) The pH of urine varies from 4.5 to 8 depending on kidney homeostasis; 2) The pH of the amniotic fluid is between 6.9 and 7.15 in late pregnancy. Since there is a range of overlapping pH between the two can be a misleading error.

Immunochromatographic tests based on antibodies that detect specific proteins in amniotic fluid or urine are not widely used because they are expensive due to monoclonal and polyclonal antibodies. In general, enzymatic methods are expensive due to the expensive production of enzymes.

It is an object of the present invention to provide an apparatus and method for distinguishing amniotic fluid from urine based on the analysis of one or more substances using dry chemical reactions without the use of enzymes or immunoassays.

Another object of the present invention is to provide a mechanism and method for distinguishing amniotic fluid from urine so as to overcome the aforementioned problems and to be simple, inexpensive and time-saving. If you are a woman or a nurse, you can tell if you have amniotic fluid or urine immediately by dropping a drop of fluid into the device. Another object of the present invention is to provide an apparatus and method for distinguishing urine and amniotic fluid that can be used in pregnant females, whether human or animal. Determining when to give birth to an animal female is more difficult to predict because it is impossible to consult the condition. Another object of the present invention is to rapidly and chemically analyze body fluids such as urine, saliva, sweat, cerebrospinal fluid (CSF) and milk.

In order to achieve the above object, the present invention provides a dry diagnostic device for distinguishing amniotic fluid and urine in the vaginal secretion: a support layer; Two reagent holding parts disposed on the support layer; And a dry reagent provided in the reagent holding unit, wherein the dry reagent is neither an enzyme nor an antibody, and performs a chemical reaction with creatinine, an alkaline phosphatase, or a protein contained in the vaginal secretion of a woman so as to visually distinguish amniotic fluid from urine. Provides a dry diagnostic to cause.

In the present invention, each of the reagent holding portions includes an absorbent material, and the absorbent material includes fiber-containing paper, fabric, nonwoven fabric, synthetic or modified natural polymer, sponge, cellulose, glass fiber, microporous membrane, wood, styrene-based copolymer, and latex. And microporous polymers such as cellulose-based or cotton fiber materials.

Dry reagents may also react with amniotic fluid or substances present in urine, and the concentration of the substance may be higher in amniotic fluid than urine or vice versa higher in urine than amniotic fluid. In this case, the layer included in one of the reagent holding portions may contain a creatinine reaction dye, a buffer and a dry fixative.

In addition, the reagent holding portion containing the reagent that reacts with creatinine includes two reagent layers, in which one creatinine reactive pigment is fixed by a fixing agent, and the other reagent layer maintains the test zone at a high pH value. May contain buffers.

In addition, in the above description, the creatinine reactive pigment is 3,5-dinitrobenzene acid, 2,4-dinitrobenzene acid, 3,5-dinitrobenzotrifluoride, 3,5-dinitrobenzamide, 3 It may be selected from the group of dinitro derivatives, including, 5-dinitrobenzoyl-phenylglycine, 3,5-dinitrohydroxyphenylpropionic acid.

In addition, the pigment fixing agent is a polymerized quaternary ammonium selected from the group consisting of poly DADMAC (polydiallyldimethylammonium chloride), polymonoallyltrimethylammonium chloride, polytrimethylaminoethyl methacrylate chloride, polyvinylbenzyltrimethylammonium chloride, polyvinylmethylpyridine-chloride It may be a cation.

In addition, the creatinine reactive pigment and the dye fixer may be buffered to maintain the pH in the range of 9-13.5.

The buffer may also be selected from the group comprising sodium metasilicate, sodium hydroxide, potassium chloride, potassium carbonate, glycine-sodium hydroxide and sodium borate.

In addition, one of the reagents in one reagent compartment may react with the protein, wherein the reagent is 3 ', 3 ", 5', 5" -tetrabromophenolsulfonephthalein, CBB (coomassie brilliant blue), fast. Fast green, light green, pyrogallol sulfonephthalein (pyrogallol red), pyrocatechol sulfonephthalein (pyrocatechol violet), 3 ', 3 "-dibromo-5', 5 "-dichlorophenolsulfonphthalein, fuxic acid, 2,4-dinitro-1-naphthol (Matius yellow), copper, lead, zinc, silver, phloxine B, Congo red, ethyl orange and methyl orange It may be a pigment selected from the group containing. In addition, the dry diagnostic apparatus of the present invention may further include a buffer selected from the group containing potassium citrate, potassium chloride, potassium sulfate, potassium iodide and potassium phosphate.

On the other hand, in the above-described dry diagnostic device of the present invention, one of the reagents in one reagent holding part may react with alkaline phosphatase, which is p-nitrophenyl phosphatase, indoxyl phosphatase, 4-methylumbehyperyl phosphatase (4- methylumbeHiferyl phosphate) and alpha-naphthyl-phosphatase.

In addition, the reagent holding portion may be covered with a transparent protective layer, or an adhesive layer may be disposed below the support layer, in which case the protective layer is covered on the outer surface of the adhesive layer.

In addition, the dry diagnostic device of the present invention may further include a metal ion selected from the group containing copper, lead, zinc, silver.

The present invention also provides a kit having a color index and a dry diagnostic device as described above, wherein the color of the diagnostic device after contacting the dry diagnostic device with amniotic fluid or urine is distinguished from the amniotic fluid and urine.

1 is a cross-sectional view of a diagnostic device according to the present invention;
2 to 5 are various diagnostics attached to the female panties in accordance with the present invention;
6 is a diagnostic pad according to the present invention;
7 is an animal diagnostic pad according to another embodiment of the present invention.

The present invention is used in the last trimester as a "band-aid" type device, in the form of a disposable pad containing a chemical indicator. The diagnostic apparatus of the present invention is a concept including a diagnostic pad. The pad is small in size and consists of at least two layers, an absorber layer containing an adhesive support layer and an indicator. Attach the diagnostic device to your panties with the test zone facing the skin. If using a panty liner, attach the diagnostic device to the top of the liner. Rapid chemical reactions in the test zone of the diagnostic device result in clear color changes when amniotic fluid leaks and other color changes occur when urine reaches the test zone. The diagnostic apparatus of the present invention can know whether the amniotic fluid or urine contained in the secretion solution by comparing with the color index.

According to a second aspect of the present invention, a pad-type diagnostic device containing an indicator can be independently attached to a female body. If the diagnostic device is pressed against the wet underwear or the panty liner after detecting the leakage of fluid, the reagent in the reagent holding part contacts the body fluid and a color change occurs due to a chemical reaction. In addition, women who use this diagnostic device can check whether the fluid contains amniotic fluid or urine.

According to a third aspect of the present invention, an indicator contained in a diagnostic device wearing a panty liner can distinguish amniotic fluid from urine. Pregnant women only need to attach the diagnostic device to their underwear. The reagent portion should be located immediately before the vagina. In this case, the pantyliner is in contact with the body fluids of the woman.

In the present invention, if storage is required, the sample may be transferred to a suitable storage container. If immediate processing of the sample is required, the sample may be dropped and tested by dropping the sample into the reagent holding part of the diagnostic apparatus.

Also, it can be used as an animal diagnostic device, in which case the adhesive part surrounds the reagent holding part and can be easily attached to the vaginal opening. Thus, contact with animal body fluids can be easily achieved. The diagnostic device can also be used without direct contact with the animal's body, in which case the fluid is collected to obtain a sample solution.

According to the present invention, it is possible to determine whether a woman's secretion has amniotic fluid or urine by color change, not by an enzyme or an immunological reaction. In most cases, the concentration difference of only one substance in the urine or amniotic fluid is measured, and the present invention measures the presence of various substances such as: protein, creatinine, urea, urobilinogen, blood, alkaline phosphatase as well as pH. It can be measured. Basically, protein and alkaline phosphatase are present in higher concentrations in nutrients than in urine, while urea and urobilinogen are present in higher concentrations in urine. Chemicals used to distinguish body fluids in accordance with the present invention change their spectral properties when combined or reacted with the materials described above.

Thus, a diagnostic device having a reagent holding section containing a chemical indicator can measure pH as well as protein, creatinine, urea, urobilinogen, blood, and alkaline phosphatase. The present invention is based on the following facts: 1) the protein concentration in the amniotic fluid is about 15 times higher than urine, 2) the concentration of creatinine and urobilinogen in the urine is about 10 times higher than the amniotic fluid, and 3) Concentration is twice as high as amniotic fluid, 4) Amniotic phosphatase is 7 times higher than urine, and 5) Outgoing amniotic fluid contains blood while the amniotic membrane is ruptured, while healthy women contain urine. have. Therefore, even if a small amount of amniotic fluid is present in the vaginal fluid, when it comes into contact with the diagnostic apparatus or the diagnostic pad of the present invention, the diagnostic apparatus can diagnose amniotic tear with a very high accuracy. Of course, other substances with similar concentration differences can be detected.

The diagnostic apparatus 10 of the present invention of FIG. 1 has a plurality of reagent holding portions 12. The diagnosis device 10 is attached to a female body, and covers the diagnosis device with the first layer 14 of a soft and comfortable material that does not irritate the skin, so that the diagnosis device is attached to the skin and panties are worn. The first layer 14 prevents direct contact between the reagents of the diagnostic apparatus 10 and the human skin. This first layer may be transparent to distinguish the colors of the layers below it.

The support layer 16 of the diagnostic device 10 supports the reagent holding unit 12 for analysis. The reagent holding part 12 includes an absorbent absorbing the sample liquid, and should not react with chemicals, but should not change the test results or the properties of the sample. In addition, fiber-containing paper such as manure paper, woven or nonwoven fabrics, synthetic or modified natural polymers, sponges, cellulose, glass fibers, microporous membranes, wood, styrene-based copolymers, microporous polymers such as latex-based, cellulose-based or cotton fiber materials Reagent holding section 12 may be made of various materials, including. The reagent holding portions 12 may be different in roughness or hardness.

In the manufacturing process, the reagent holding part may be made into a multilayer structure, and may have different reagents in each test zone. Arbitrary combinations of the support layer and the reagent holding part are also included in the scope of the present invention. The adhesive layer and the protective layer 20 are sequentially disposed under the support layer 16. These two layers are similar in nature to the layers formed on the panties. The reagent holding portions 12 are organized into groups, and each group includes indicators representing one of the substrates listed above. Hereinafter, the Example of the method of manufacturing a reagent and a test zone is demonstrated.

Example

Creatinine test zone preparation

Creatinine levels are about 10 times higher in urine than amniotic fluid. The creatinine dry test is done in two ways:

A two-layer system in which creatinine reactive pigments and buffers that keep the pH of the system high are placed in different layers, each with two reagent layers;

One layer system in which creatinine reactive pigment, buffer and fixer are all placed on the same layer so that one reagent layer is used.

The creatinine reactive pigments are 3,5-dinitrobenzene acid, 2,4-dinitrobenzene acid, 3,5-dinitrobenzenetrifluoride, 3,5-dinitrobenzamide, 3,5-dinitrobenzoyl- Dinitro derivatives such as phenylglycine, 3,5-dinitrohydroxyphenylpropionic acid. The fixing agent for this pigment is a polymerized quaternary ammonium cation such as polydiallyldimethylammoniumchloride (polydiallyldimethylammoniumchloride), polymonoallyltrimethylammonium chloride, polytrimethylaminoethylmethacrylate chloride, polyvinylbenzyltrimethylammonium chloride, polyvinylmethylpyridine-chloride ( contains quats).

The buffer should have a strong base that can keep the pH stable in the range of 9 to 13.5, for example sodium metasilicate, sodium hydroxide, potassium chloride, potassium carbonate, glycine-sodium hydroxide, sodium borate.

Non-volatile solid reagents may also be added to the pigment to increase reactivity.

Two-layer system; Example 1

A creatinine test indicator consisting of two reagent holding sections was installed in the support layer of the diagnostic device. As a water-soluble fixative, creatinine reactive dye, 3,5-dinitrobenzene acid (dBA), and poly DADMAC were imbibed into the first reagent reservoir (which could be Whatman filter paper or endinkin), and poly DADMAC is optional. The dBA solution was mixed in sodium carbonate buffer. The second reagent reservoir was wetted with sodium metasilicate buffer. After both reagent reservoirs were dried, the first reagent reservoir was placed on the second reagent reservoir infiltrated with sodium metasilicate buffer. Both dry reagent holding portions were placed on the support layer of the diagnostic apparatus and pressed.

When the vaginal discharge meets the dry reagent holding section, the color changes significantly to indicate the presence of amniotic fluid or urine.

Two-layer system; Example 2

Two reagent holders were soaked in each solution, dried and placed on the support layer of the diagnostic apparatus. Specifically, Solution 1 consisting of dBA as a creatinine reactive dye, a nonvolatile solid reagent as a fixative, and poly DADMAC was absorbed into the first reagent holding portion. Solution 2 containing sodium hydroxide was absorbed into the second reagent reservoir. Both reagent holders were dried and then the reagent holder of Solution 1 was placed on the reagent holder of Solution 2, and both reagent holders were pressed on the support layer of the diagnostic device.

One-tier system; Example 1

As mentioned above, the "1st floor system" is basically the same as the "2nd floor system" except that all chemicals are in one reagent reservoir, and both systems use creatinine to separate urine and amniotic fluid. For the purpose of

A creatinine tester with the same absorbent and retention as a two-layer system was prepared. The reagent holding part is composed of creatinine reactive colorant, nonvolatile solid reagent, fixed solution and buffer, all of which are placed on the reagent holding part and dried. 3,5-dinitrobenzene acid (reserved solution made of acetonitrile) as a reaction pigment, poly DADMAC as fixed solution, and potassium hydroxide (in ethyl alcohol solution) as buffer solution were used. All of these reagents were dried and then prepared for urine or amniotic fluid sample testing.

One-tier system; Example 2

An emulsion consisting of 3,5-dinitrobenzene acid, poly DADMAC, styrene acrylic acid, sodium metasilicate and a nonvolatile solid reagent was prepared. The latex substrate was sprayed with a thin film of emulsifier and then dried. The dried substrate was placed on the support layer of the diagnostic apparatus and pressed.

Total Protein Test Zone Preparation

Amniotic fluid is about 15 times higher than urine. The protein reaction between the dye and the metal ion results in a spectral change in the dye-metal ion solution. When absorbing the diagnostic device of the present invention, 3 ', 3 ", 5', 5" -tetrabromophenol sulfone phthalein, CBB (coomassie brilliant blue), fast green, light green ), Pyrogallol sulfonephthalein (pyrogallol red), pyrocatechol sulfonphthalein (pyrocatechol violet), 3 ', 3 "-dibromo-5', 5" -dichlorophenolsulfonphthalein, fucin Acids, 2,4-dinitro-1-naphthol (Matius yellow), copper, lead, zinc, silver, phloxine B, Congo red, ethyl orange or methyl orange can be used as pigments and metal ions.

The reagent holding portion of the protein tester is an absorbent and may be made of a styrenic copolymer, a microporous polymer of latex or cellulose or a surface substrate. This reagent holding portion (introduced in US Pat. No. 5,124,266) contains a polymerized urethane-based compound that contains an indicator reagent that acts on a protein to produce a visually recognizable reaction. To reduce variability due to the difference in density of urine, low pH potassium-based buffers such as potassium citrate, potassium chloride, potassium sulfate, potassium iodide and potassium phosphate can be added to the tester.

Protein Testing: Examples

The protein test solution is a mixture of two pigment solutions and a buffer solution. 3 ', 3 ", 5', 5" -tetrabromophenolsulfonphthalein was dissolved in a weak organic acid such as citric acid and used as a dye solution. Potassium citrate dissolved in a weak organic acid at pH 3.5 was used as a buffer.

Subsequently, after diluting the dye solution with the buffer solution, the solution was sprinkled with a thin film on the reagent holding portion and dried. When urine and amniotic fluid were brought into contact with the reagents of the diagnostic device, the color reaction of the urine was markedly different.

Alkaline Phosphatase Test Zone Preparation

The activity in amniotic fluid of alkaline phosphatase is much higher than in normal urine. Thus, this activity can be used to distinguish amniotic fluid from urine in vaginal discharge, in which case dry testers are used that come into contact with vaginal discharge and cause a pronounced color change. Dropping vaginal secretions into the dry reaction zone causes color changes in the vaginal secretions, which can be used to distinguish whether the vaginal secretions contain amniotic fluid or urine.

Alkaline Phosphatase Test: Examples

Reaction reagents for the detection of alkaline phosphatase include dry buffer solutions of alkaline phosphatase such as p-nitrophenyl phosphatase, indoxyl phosphatase, 4-methylumbeHiferyl phosphate and alpha-naphthyl-phosphatase. Indicators such as bromocresol green were contained.

The diagnostic apparatus attached to the panties for women according to the present invention will be described with reference to FIGS. All the diagnostic devices shown have a support layer 22 having a layer structure similar to that of FIG. 1, and can be directly attached to the women's panties. The layer having the test zone described below is positioned at the female vaginal inlet. In the drawings, for convenience of description, the protective film will be described in a peeled state. The test zone of the diagnostic device 20 of FIG. 2 is divided into five reagent holding parts 24 to 32. The indicator contained in each reagent holding portion is used to identify a specific substrate as described above, specifically, creatinine, protein, alkaline phosphatase, and the like can be tested.

The diagnostic apparatus 40 of FIG. 3 has three test zones 12, each of which is divided into five reagent holding sections, and each of the reagent holding sections includes a separate indicator for distinguishing urine and amniotic fluid.

The diagnostic device 50 of FIG. 4 is similar to the diagnostic device 20 described above, but has four reagent holding parts 54-58. The diagnostic device 60 of FIG. 5 has three test zones 12, and the reagent holding portions 62-68 of each test zone have separate indicators for distinguishing urine and amniotic fluid.

As described above, the reagent holding portion of the diagnostic device according to the present invention is two or more in a linear, circular or other form, it is possible to distinguish the urine and amniotic fluid through the change in the color of the two or more indicators.

The diagnostic pad according to another embodiment of the present invention of Figure 6 is pressed against the wet panties, so that the pad does not directly contact the skin. Basically, this pad is to be bonded without the adhesive layer.

Reagent holding portions 74-79 having different indicators are disposed on the support layer 72 of the pad 70 of FIG. 6A. Each reagent reservoir is used to identify a substance as described above. The reagent holding portion is also disposed in the support layer 82 of the pad of FIG. 6B. Such a reagent holding part may be arranged like the reagent holding parts 94 to 98 of FIG. 6C or the reagent holding parts 104 to 106 of FIG. 6D.

7 is a diagnostic device for livestock, and the diagnostic device 120 is basically similar to the human one, but the adhesive part 122 surrounds the test zone 124 of the diagnostic device 120.

Claims (27)

In a dry diagnostic device to distinguish amniotic fluid from urine in vaginal fluid:
Support layer;
Two reagent holding parts disposed on the support layer;
Includes; a dry reagent provided in the reagent holding portion;
The dry reagent is neither an enzyme nor an antibody, and a dry diagnostic apparatus for causing a chemical reaction with creatinine, an alkaline phosphatase or a protein contained in a vaginal secretion of a female so as to visually distinguish amniotic fluid from urine. The method of claim 1, wherein each of the reagent holding portion comprises an absorbent material, the absorbent material is fiber-containing paper, woven fabric, non-woven fabric, synthetic or modified natural polymer, sponge, cellulose, glass fiber, microporous membrane, wood, styrene-based nose A dry diagnostic apparatus comprising a polymer, a microporous polymer such as latex, cellulose, or cotton fiber materials. The dry diagnostic apparatus according to claim 1, wherein the dry reagent may react with a substance present in amniotic fluid or urine, and the concentration of the substance is higher in amniotic fluid than urine or vice versa. 2. The reagent holding part according to claim 1, wherein the reagent holding portion containing the reagents reacting with creatinine comprises two reagent layers, wherein one reagent layer is fixed with a creatinine reactive pigment by a fixing agent, and the other reagent layer has a high test zone. Dry diagnostic apparatus characterized in that it contains a buffer that can be maintained at a pH value. The dry diagnostic apparatus according to claim 3, wherein the layer included in one of the reagent holding portions contains a creatinine reaction dye, a buffer, and a dry fixative. The method according to claim 4, wherein the creatinine reactive pigment is 3,5-dinitrobenzene acid, 2,4-dinitrobenzene acid, 3,5-dinitrobenzotrifluoride, 3,5-dinitrobenzamide, 3 Dry diagnostic group, characterized in that selected from the group of dinitro derivatives, including, 5-dinitrobenzoyl-phenylglycine, 3,5-dinitrohydroxyphenylpropionic acid. The method according to claim 5, wherein the creatinine reactive pigment is 3,5-dinitrobenzene acid, 2,4-dinitrobenzene acid, 3,5-dinitrobenzotrifluoride, 3,5-dinitrobenzamide, 3 Dry diagnostic group, characterized in that selected from the group of dinitro derivatives, including, 5-dinitrobenzoyl-phenylglycine, 3,5-dinitrohydroxyphenylpropionic acid. The method of claim 4, wherein the pigment fixing agent is selected from the group comprising polydiallyldimethylammoniumchloride (poly DADMAC), polymonoallyltrimethylammonium chloride, polytrimethylaminoethyl methacrylate chloride, polyvinylbenzyltrimethylammonium chloride, polyvinylmethylpyridine-chloride Dry diagnostic apparatus characterized in that the polymerized quaternary ammonium cation (quats). The method of claim 5, wherein the pigment fixing agent is selected from the group comprising polydiallyldimethylammoniumchloride (poly DADMAC), polymonoallyltrimethylammonium chloride, polytrimethylaminoethyl methacrylate chloride, polyvinylbenzyltrimethylammonium chloride, polyvinylmethylpyridine-chloride Dry diagnostic apparatus characterized in that the polymerized quaternary ammonium cation (quats). The dry diagnostic apparatus according to claim 4, wherein the creatinine reactive pigment and the dye fixative are buffered to maintain the pH in the range of 9 to 13.5. The dry diagnostic apparatus according to claim 5, wherein the creatinine reactive pigment and the dye fixative are buffered to maintain the pH in the range of 9 to 13.5. The dry diagnostic apparatus according to claim 4, wherein the buffer is selected from the group consisting of sodium metasilicate, sodium hydroxide, potassium chloride, potassium carbonate, glycine-sodium hydroxide and sodium borate. 6. The dry diagnostic apparatus according to claim 5, wherein the buffer is selected from the group consisting of sodium metasilicate, sodium hydroxide, potassium chloride, potassium carbonate, glycine-sodium hydroxide and sodium borate. The dry diagnostic apparatus according to claim 1, wherein one of the reagents of one reagent holding part reacts with the protein. The method of claim 14, wherein the reagent reacting with the protein is 3 ′, 3 ″, 5 ′, 5 ″ -tetrabromophenolsulfonphthalein, coomassie brilliant blue, fast green, light green. green), pyrogallol sulfonephthalein (pyrogallol red), pyrocatechol sulfonphthalein (pyrocatechol violet), 3 ', 3 "-dibromo-5', 5" -dichlorophenolsulfonphthalein, fu Characterized in that it is a pigment selected from the group comprising xynic acid, 2,4-dinitro-1-naphthol (Matius yellow), copper, lead, zinc, silver, phloxine B, Congo red, ethyl orange and methyl orange Dry diagnostics. 16. The dry diagnostic apparatus according to claim 15, further comprising a buffer selected from the group comprising potassium citrate, potassium chloride, potassium sulfate, potassium iodide and potassium phosphate. The dry diagnostic apparatus according to claim 1, wherein one of the reagents of one reagent holding part reacts with an alkaline phosphatase. 18. The method of claim 17 wherein the reagent reacting with alkaline phosphatase is selected from the group comprising p-nitrophenyl phosphatase, indoxyl phosphatase, 4-methylumbeHiferyl phosphate and alpha-naphthyl-phosphatase Dry diagnostics characterized in that. The dry diagnostic apparatus according to claim 1, wherein the reagent holding part is covered with a transparent protective layer. The dry diagnostic apparatus according to claim 1, wherein an adhesive layer is disposed under the support layer. The dry diagnostic apparatus according to claim 20, wherein a protective layer is covered on an outer surface of the adhesive layer. The dry diagnostic apparatus according to claim 15, further comprising a metal ion selected from the group consisting of copper, lead, zinc, and silver. In a kit with a color index and the dry diagnostic device of claim 1:
The dry diagnostic device after the contact with the amniotic fluid or urine kits, characterized in that to distinguish between the amniotic fluid and urine by comparing the color index. The dry diagnostic apparatus according to claim 20, wherein a protective layer is covered on an outer surface of the adhesive layer. The dry diagnostic apparatus according to claim 1, wherein the two reagent support portions are formed in parallel and parallel. The dry diagnostic apparatus according to claim 1, wherein the two reagent support portions are concentric circles. The dry diagnostic apparatus according to claim 1, wherein the reagent support is surrounded by an adhesive material so that the test zone can contact the diagnostic device when the test zone is located at the vaginal opening of the female animal.

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