KR20000054484A - Self ovulation diagnostic kit with parts for examining health indexes using the urine specimen - Google Patents

Abstract

PURPOSE: A self ovulation diagnostic kit with parts for examining health indexes is provided to help decide pregnancy or contraception by adding an external examination test to an ovulation diagnostic kit with indexes on a health state affecting the pregnancy. CONSTITUTION: A health index examination part(1) is to examine health indexes related to pregnancy by using urine. The health index examination part is attached with diagnostic tests for examining the amount of leucocyte, hematocyte, pH, protein, glucose, specific gravity, urobilinogen, bilirubin, ketones, nitrite, vitamin C and so on. A part(2) is punched to dip the urine in an examination test among ovulation diagnostic parts. The(T) is a test part mark to confirm LH-surge and the(C) is a comparison test part to confirm the normal reaction of the ovulation diagnostic sample. A Part(6) is made up of a plastic material and consisted of upper and lower face as a supporting body.

Description

Self ovulation diagnostic kit with parts for examining health indexes using the urine specimen}

The present invention relates to an in vitro diagnostic drug among diagnostic reagents of medical drugs, in particular, 11 health indicator diagnostic items using red urine (red blood cell (RBC), white blood cell (WBC), protein, glucose, hydrogen ion concentration (pH), specific gravity, Eurobilinogen, bilirubin, ketone body, nitrite, vitamin C} together with the ovulation diagnostic reagent in one kit, and in a single test to provide ovulation time prediction and pregnancy-related health information for women in a self-ovulation diagnostic kit It is about.

The existing ovulation diagnostic kit is designed to predict the ovulation date by simply checking the LH-Surge. Therefore, when the user wants to use the ovulation diagnostic kit for pregnancy, the health indicator that can confirm whether the state of health is appropriate or improper for pregnancy was not provided.

Therefore, in the present invention, the urine erythrocyte (RBC), leukocyte (WBC), protein, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone body, nitrite, vitamin C, etc. By adding in vitro diagnostic reagents that can be used to diagnose ovaries, we provide women with this diagnostic kit with predictive ovulation dates and indicators of health conditions affecting pregnancy, helping to determine pregnancy or contraception. will be.

An object of the present invention is a health indicator test site and the ovulation diagnostic site is disposed together, the health indicator test site is fixed on the absorber, the diagnostic reagent for examining the health indicator to a certain area, the ovulation diagnostic site is the upper part of the absorber ( Ovulation Diagnosis Display Window) Provides a self-ovulation diagnostic kit for diagnosing health indicators and predicting ovulation date, which includes a moving unit for moving urine, an ovulation diagnosis display window for ovulation, and an end-of-test display window for completing the test. It is.

1A is a plan view of an example (type 1) according to the present invention

Figure 1b is a plan view of the upper surface of the body in Figure 1a removed

2A is a plan view of another example (type 2) according to the present invention;

FIG. 2B is a plan view of the plastic structure 7 with the inspection site of the health indicator removed in FIG. 2A

FIG. 2C is a plan view of the upper surface of the plastic structure 8 having the ovulation diagnostic site in FIG. 2B removed.

The present invention is a self-ovulation diagnostic kit including test functions such as red blood cell (RBC), white blood cell (WBC), protein, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone body, nitrite, vitamin C, etc. For ovulation diagnostic kits and ovulation diagnostic kits and urine, red blood cell (RBC), white blood cell (WBC), protein, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone body, nitrite, vitamin C In order to make an in vitro diagnostic kit, ovulation diagnostic reagent, red blood cell (RBC), white blood cell (WBC), protein, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone body, nitrite, vitamin C diagnostic reagent It was configured to be included in one kit.

When explaining the terms and diagnostic principles used in the diagnostic kit of the present invention.

1. Principles of Ovulation Diagnosis and How It Works

Ovulation is a phenomenon in which the egg is released from the follicle by the action of human luteinizing hormone (hLH) after the ovarian follicle is matured by Follicle Stimulation Hirmone (FSH), an anterior lobe of the pituitary gland.

This hLH is secreted in small amounts during most of the menstrual cycles, but the amount of hLH increases rapidly in the middle of the cycle, called LH-Surge, and ovulation usually occurs within 24-36 hours after LH-Surge. Discharged.

Therefore, it is possible to predict the ovulation time by detecting the LH-Surge during the menstrual cycle using the antigen-antibody reaction between the hLH in the urine and the hLH single antibody attached to the ovulation diagnostic kit. Urinary hLH concentrations during the menstrual cycle are shown in Table 1.

TABLE 1

Menstruation HLH concentration in urine (mlU / ml) Foundation level 5-20 Surge-level 40-200 Postmenopausal women 10-200 male 2-15

In a conventional study, hLH antibodies were synthesized and purified from cells such as mice and goats to obtain a single antibody that specifically binds to hLH, and an ovulation diagnostic kit using the same has been produced. This ovulation diagnostic kit predicts ovulation date (24–36 hours after LH-Surge) by identifying hLH-Surge using antigen-antibody reactions between urinary hLH and hLH monoantibodies attached in ovulation diagnostic kit.

Ovulation diagnostic kit consists of urine absorption site, ovulation diagnosis site, and connection site. The urine-absorption site component is an absorbent paper, and the connection site is mouse anti-hLH monoclonal antibody-colloidal gold conjugates (with an arbitrary color) in glass fiber, absorbent paper, and cellulose paper. (5 in Fig. 1B and 11 in Fig. 2C), a goat anti hLH polyclonal antibody is applied to the ovulation display window (T in Figs. 1A and 2A) of the ovulation diagnosis site, and the ovulation diagnosis site is The goat end anti-mouse antibody (IgG) was applied to the end-of-test display window (FIGS. 1A and 2A). At this time, the amount of the mouse anti hLH monoantibody-colloidal gold particle mixture is greater than that of the chlorine anti hLH complex antibody (T) in the ovulation display window. Urine hLH detection limit for ovulation diagnostic kits is approximately 25 mIU / ml.

* hLH-Surge, ie 1-1.5 days before ovulation

Traveling on a yogurt rod, the urinary tract hLH binds to the mouse anti-hLH monoantibody-colloidal gold particle mixture. As the conjugate continues to move along the urine and stays in association with the anti-hLH complex antibody of chlorine in the ovulation display window (T), any particular color appears. And, the remaining hRH monoantibody-colloidal gold particle mixture of the surplus rat remaining on the ovulation display window moves and stays in combination with the anti-mouse antibody of the goat coated on the test display window, which causes certain specific colors to appear. Check if the test reagent is working properly. Therefore, two lines appear in the ovulation display window and the inspection end display window, respectively.

* not hLH-Surge

In this case, the hLH concentration is very low in the urine. In this case, the anti-hLH monoclonal-colloidal particle mixture of rats does not bind with the anti-hHL complex antibody of chlorine in the ovulation display window, and just passes. Any specific color will appear in combination with only the anti-mouse antibody of goats applied to the screen. Therefore, a line appears only at the end of inspection window.

2. Test Principle of Health Indicators Using Urine

1) Red blood cell test: The activity of heme peroxidase free from red blood cell hemoglobin is used. The peroxidase activity of erythrocyte hemoglobin promotes the reaction of 3.3, 5.5-tetramethylbenzidine, 2.5 dimethyl nucleic acid-2.5-dihydroperoxide and organic peroxide. As a result, the color of the reagent changes from greenish-yellow to dark blue in proportion to the amount of red blood cells in the urine.

2) Leukocyte Test: Apply the activity of esterase in neutrophils, which is the majority of leukocytes. Esterase of erythrocytes acts on the thiazole amino acid esters to convert it to hydroxy thiazole, which reacts with the diazonium salt to appear purple. That is, the amount of urine red blood cells and the concentration of purple are proportional.

3) Protein testing: It takes advantage of the property that tetrabromophenol blue reacts with proteins to discolor (change from yellow to green-blue green).

4) Glucose Test: Uses two steps of enzyme reaction. First, glucose oxidase breaks down glucose to form gluconic acid and hydrogen peroxide, and peroxidase reacts hydrogen peroxide with potassium iodide (potassium iodate chromogen) to oxidize chromogen to turn the color blue or greenish brown. Change to dark brown.

5) Hydrogen ion concentration test: The color change (orange, yellow green, or green to blue) according to the hydrogen ion concentration of methyl red and bromothymol blue is used. 6) Specific gravity test: according to the pka change with respect to the concentration of the ionized positive and Polyelectrolytes (-COOH) there is H ⁺ is released by the reaction of n in the H ⁺ reacts with the indicator to display the changes in the pH value of the color Cause

7) Eurobilinogen test: 4-methoxybenzodeazonium and eurobilinogen in urine are used to change color from pink light to reddish brown color by diazonium reaction under strong acid conditions.

8) Bilirubin test: Urinary bilirubin reacts with diazonium salts to change the indicator from brown to purple.

9) Ketone body test: The color of the indicator changes from brown to purple due to the reaction of urine acetoacetic acid and nitroprusside.

Nitrite Test: Reaction with arsanilic acid and urine nitrite to form diazonium, which is N- (1-naphthyl) ethylen ?? diamine or 3-hydroxy 1,2 Reacts with, 3,4-tetrahydro-benzo (h) quinoline to cause color change of the indicator.

11) Vitamin C: Ascorbic acid reacts with 2,6-dichlorophenol indophenol sodium to change pH, changing the color of methyl red, a pH indicator.

In vitro diagnostic reagents using this principle have been prepared and used.

3. Clinical Significance of Health Indicators

The clinical significance of the health indicators used in the present invention is shown in Table 2.

TABLE 2

Inspection items Clinical Significance Red blood cells (RBC) Nephritis, pyelonephritis, cystitis, tubular stones, acute hepatitis, neo-uropathy. Leukocytes (WBC) Nephritis, nephrase, inflammation of the urine (nephritis, pyelonephritis, cystitis, urethritis) Protein Pyelonephritis, pyelonephritis, cystitis, urinary tract, nephropathy, diabetes, nephropathy, heart failure, hemolytic disease, collagen fever, overwork, addictive disease Glucose Diabetes mellitus, hyperthyroidism, pregnancy, intracranial hypertension, taking steroids Hydrogen ion concentration (pH) Acidic: Diabetes, Gout, Nephritis, Alkaline: Urinary tract infections (modified bacteria), Antacids Administration, Hyperventilation, frequent vomiting Specific gravity If lowered: Hypothermia, diabetes insipidus (antidiuretic hormone deficiency), glomerulonephritis, pyelonephritis; elevated: congestive renal failure, proteinuria, diabetes, high fever, sweating. Eurobilinogen Hepatic dysfunction: Liver, cholangiopathy, congestive heart failure Mechanism of destruction: congestive anemia, pernicious anemia: Complete blockage of bile ducts, end of hepatic jaundice, high heart failure, antibiotics Bilirubin Hepatitis, cirrhosis, liver cancer, bile duct disease, pancreatic disease, jaundice, drug addiction, pregnancy. Ketones Diabetic asisosis, low carb high fat diet. Nitrite Pyelonephritis, cystitis, urethritis. Vitamin c The presence of vitamin C in the urine is important because it inhibits erythrocytes, glucose, and bilirubin test.

Hereinafter, an example of the present invention will be described in detail with reference to the drawings.

Such a kit may consist of a first type shown in FIG. 1 and a second type shown in FIG. 2. In FIG. 1A, the health indicator test site 1 is a site for examining health indices related to pregnancy using urine, and red blood cells (RBC), white blood cells (WBC), proteins, glucose, hydrogen ion concentration (pH), and specific gravity on a plastic plate. There are diagnostic reagents that can check the amount of eurobilinogen, bilirubin, ketone bodies, nitrites, and vitamin C. In (2), holes are drilled in order to wet the urine into the diagnostic reagent, which is the ovulation diagnostic site for predicting ovulation date using urine. (T) indicates the test site to confirm the LH-Surge, (C) is a control site (test end display window) to confirm the normal response of the ovulation diagnostic reagent. (6) is a support for supporting the diagnostic reagents, which is made of plastic and consists of an upper surface and a lower surface. In Figure 1b, (3) is the absorbent paper laid under the health indicator test site (1), (4) is the ovulation diagnostic reagent site. (5) is a mouse anti-hLH monoantibody-colloidal gold particle mixture, (T) is a goat anti-hLH complex antibody, (C) is a goat anti-mouse antibody (Immunoglobulin G: IgG), and these components are (4) Fibers, composed of cellulose paper and absorbent paper).

In Figure 2a (7) and (8) is a structure that can be separated as the main body constituting the kit. (8) is a state where two plastic structures (top and bottom) are joined. (9) is a display window of the ovulation diagnostic site for predicting ovulation date using urine. (T) and (C) have the same function as the site described in FIG.

FIG. 2B (10) shows a health indicator inspection site as shown in (1) of FIG. 1 after removing 7 of FIG. 2A. Later in (10), there is a urine absorbing rod (consisting of glass fiber, cellulose paper and absorbent paper) for reacting urine to the ovulation diagnosis site. 2C is the same component as 5 in FIG. 1B.

The composition of the present invention is shown in Table 3 below.

TABLE 3

division Furtherance Self ovulation diagnostic kit with parts for examining health indexes using the urine specimen Pregnancy Diagnosis Reagents Red Blood Cells Reagents White Blood Cells Reagents Proteins Reagents Glucose Tests Reagents Hydrogen Ion Concentration Reagents Weight Test Reagents Eurobilinogen Test Reagents Bilirubin Test Reagents Ketone Test Reagents Nitrite Test Reagents Vitamin C Test Reagents

The reagent components, the amount of use and the quantitative range of each item of the self-ovulation diagnostic kit of the present invention are specified as follows (the amount used means the amount of reagent used in one reaction site).

1. Pregnancy test site

1) Ingredients and Usage

Mouse anti-hCG single antibody-colloidal gold particles: 5.00-10.00 μg

Anti-alpha or beta hCG complex antibody of chlorine: 2.00-2.50 μg

Goat anti mouse antibody (IgG): 0.50-1.00 μg

2) Quantitative range: 0.00-250.00 IU / L

3) Range of reaction: 1,000-250,000 IU / L

2. Red blood cell test site

1) Ingredients and Usage

25.0 μg O-Tolidine

Cumin hydroperoxide 236.0 μg

or

-2.5 dimethyl nucleic acid-2.5-dihydroperoxide 400.0 μg

-3,3.5,5-tetramethylbenzidine 37.0 μg

2) Quantitative range: 0-250 RBC / μl

3) Reaction range: 10-250 RBC / μl

3. White blood cell test site

1) Ingredients and Usage

-Naphthol Aesdi Chloroacetate: 75.0 μg

2-Chloro-4-benzamide-5-methelbenzene diazonium hemizin chloride: 2.5µg

or

2-Phenylthizazole amino acid ester: 10.0 µg

Diazonium salt: 7.0 ㎍

2) Quantification range: 0-500 WBC / μl

3) Range of reaction: 10-500 WBC / μl

4. Protein Testing Site

1) Ingredients and Usage

Bromine Phenol Blue: 2.0 μg

-Citric Acid: 1.1mg

Trisodium citrate: 460.0 μg

2) Quantification range: 0.00-1000.00 mg

3) Reaction range: 5.00-1000.00 mg / 100ml

5. Glucose Test Site

1) Ingredients and Usage

Glucose Hydrogen Oxide: 4.6 units

Hydrogen peroxide: 21.0 units

Potassium iodide: 139.0 μg

2) Quantification range: 0.00 -2000.00 mg / 10ml

3) Range of reaction: 100.00-2000.00 mg / 100ml

6. Hydrogen ion concentration (pH) inspection site

1) Ingredients and Usage

Methyl red: 0.3 μg

Bromothymol Blue: 5.0 μg

2) Reaction range: pH 5.0-9.0

7. Specific gravity inspection site

1) Ingredients and Usage

Bromine mol blue: 56.0 μg

Sodium hydroxide: 556.0 µg

Poly (methylvinylether / maleic anhydride): 1.34 μg

2) Reaction Range: 1.00g / ml-1.03g / ml

8. Eurobilinogen Inspection Site

1) Ingredients and Usage

-P-dimethylaminobenzaldehyde: 145.4 μg

or

Methoxybenzenediazonium 25.0µg

Citric Acid: 300.0 μg

2) Quantitative range: Ehrlich unit (100 ml) 0.1 unit-12 unit

3) Reaction range: Ehrlich unit (100 ml) 0.1 unit-12 unit

9. Bilirubin Test Site

1) Ingredients and Usage

Sodium nitrite: 7.33 µg

or

-2,4-dichlorobenzenediazonium salt: 30.0 µg

Oxalic acid: 300.0 μg

2) Quantitative range: 0.0mg / 100ml-3.0mg / 100mg

3) Range of reaction: 0.5mg / 100ml-3.0mg / 100mg

10. Ketone body inspection site

1) Ingredients and Usage

Nitropurusidium sodium: 200.0 μg

Magnesium sulfide: 2.46 mg

2) Quantitative range: 0.0mg / 100ml-100mg / 100ml

3) Reaction range: 10mg / 100ml-100mg / 100ml

11. Nitrite Inspection Site

1) Ingredients and Usage

Arsaneyl acid: 50.0 μg

-N- (1-naphthyl) ethylenediamine: 60.0 μg

or

Arsaniyl acid: 1.4% w / w

3-hydroxyl, 2,3,4-tetrahydro-benzo (h) quinoline: 1.3% w / w

2) Range of reaction: negative and positive

12. Vitamin C Test Site

1) Ingredients and Usage

-2,6-dichlorophenol indophenol sodium: 7.5 μg

Methyl red: 7.5 μg

In the case of the ovulation diagnostic site of the above reagent components, each component is fixed or sprayed in the 1 mm x 3 mm plane range. Mouse anti-hLH monoclonal-colloidal gold particle mixtures were sprayed to move along the urine, and goat's anti-hLH complex antibody and goat's anti-mouse antibody (IgG) were fixed and applied.

In addition, test components such as red blood cell (RBC), white blood cell (WBC), protein, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone body, nitrite, vitamin C, etc. It is applied.

The range of components of the diagnostic reagents capable of diagnosing red blood cells (RBC), white blood cells (WBC), protein, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone body, nitrite, vitamin C, etc. In addition to the reagent components, red blood cells (RBC), white blood cells (WBC), proteins, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone bodies, nitrites, vitamin C, etc. In addition, the scope of the ovulation diagnostic reagent may be used to synthesize a single or complex antibody having the same purpose in another laboratory animal, in addition to the mouse anti-hLH monoantibody-colloidal gold particle mixture, goat anti-hLH complex antibody, and goat anti-mouse antibody (IgG). It includes one case.

Looking at the specific application of the present invention,

Example 1) A hLH-positive reaction at the site of ovulation diagnosis and a high concentration of eurobilinogen in urine are suspected of causing liver dysfunction, anemia, or antibiotics. Therefore, visit a specialist / clinic to determine pregnancy or contraception after diagnosis.

Example 2) If hLH-positive and high urine glucose levels are observed in the ovulation diagnostic site, diabetes is suspected. Diabetes may cause disorders in pregnancy. Therefore, visit a specialist / clinic to determine pregnancy or contraception after diagnosis.

Example 3) When hLH is positive for ovulation diagnosis and all items of urine are in the normal range, it helps to determine pregnancy.

The effect of the present invention is to diagnose the ovulation date of the user together with the health indicators that may affect pregnancy, and when the user's health condition is inappropriate for pregnancy by inducing a visit by a specialist / clinician to be diagnosed by the user Or help determine the contraceptive.

Claims (5)

The health indicator test site and the ovulation diagnosis site are arranged together, The health indicator test site is fixedly coated with a certain amount of diagnostic reagent that checks the health indicator on the upper part of the absorber. Ovulation diagnostic site is a self-ovulation diagnostic kit that can diagnose the health indicator and predict the ovulation date composed of the moving part for moving the urine to the upper part of the absorber, the ovulation display window indicating whether ovulation, and the end of the test display. The self-ovulation diagnostic kit according to claim 1, wherein the health indicator test site is located on top of the ovulation diagnosis site. The self-ovulation diagnostic kit according to claim 1, wherein the health indicator test site is positioned in parallel with the ovulation diagnosis site. The self-ovulation diagnostic kit according to claim 1, wherein a plurality of diagnostic reagents are fixedly coated at regular intervals so that the health indicator test site can diagnose the plurality of health indicators. The self-ovulation diagnosis according to claim 4, wherein the diagnostic reagent is a reagent for testing red blood cells (RBC), white blood cells (WBC), proteins, glucose, hydrogen ion concentration (pH), specific gravity, eurobilinogen, bilirubin, ketone bodies, nitrites, and vitamin C. Kit.