RU2804643C1 - Method of conducting a general clinical urine analysis using a diaper - Google Patents

Abstract

FIELD: medicine; clinical and laboratory diagnostics.

SUBSTANCE: group of inventions can be used to evaluate general clinical urine analysis in children under 1 year of age and in bedridden patients. A method of conducting a general clinical analysis of urine using a diaper is as follows: a strip with reagents for conducting a general clinical analysis of urine is placed in the absorbent layer of the diaper, the indicators of the said strip are located in a non-woven surface layer divided by an inactive non-woven material into ten equal signed parts: pH, specific gravity, erythrocytes, leukocytes, protein, glucose, ketone bodies, nitrites, bilirubin, and urobilinogen. When the patient's urine interacts with the reagents, a chemical reaction occurs, accompanied by a change in the color of the reagents depending on the qualitative and quantitative composition of the indicators of the general clinical analysis of urine, on the surface non-woven layer of the diaper, each of the ten parts of the indicator strip changes color depending on the qualitative and quantitative composition of the analyzed indicators of the general clinical analysis urine, the change in the color of the indicator strip is compared with the colors of the reference graduated indicator strip supplied with the diaper, the color of each analyzed indicator of the general clinical analysis of urine on the reference graduated indicator strip corresponds to the composition of the analyzed indicators of the general clinical analysis of urine. A variant of the method of conducting a general clinical analysis of urine using a diaper is also disclosed.

EFFECT: group of inventions provides a simplification of the solution of the issue of conducting a general clinical analysis of urine, as well as its interpretation.

2 cl, 3 ex, 3 dwg

Description

The invention relates to medicine, in particular to clinical and laboratory diagnostics. It can be used in the clinic for rapid assessment of general clinical urine analysis parameters.

The technical result of the invention is to simplify the solution to the issue of conducting a general clinical urine test in children and bedridden patients, as well as its interpretation.

The essence of the invention (according to the formula).

The proposed method for determining a general clinical urine analysis using a diaper is that a strip with reagents for conducting a general clinical urine analysis is placed in the absorbent layer of the diaper, the indicators of which are located in the non-woven surface layer - indicators of general clinical urine analysis in the form of a graduated white indicator strip, divided inactive nonwoven material into ten equal parts labeled: pH, specific gravity, red blood cells, white blood cells, protein, glucose, ketone bodies, nitrites, bilirubin, urobilinogen (Fig. 1). When the patient's urine interacts with reagents for determining the indicators of a general clinical urine test, a chemical reaction occurs in the adsorbent layer, accompanied by a change in the color of the reagents depending on the qualitative and quantitative composition of the indicators of a general clinical urine test. On the surface non-woven layer of the diaper, each of the ten parts of the indicator strip begins to change color depending on the qualitative and quantitative composition of the analyzed indicators of a general clinical urine test.

Compare the color change of the indicator strip on the surface non-woven layer of the diaper with the colors of the reference graduated indicator strip supplied with the diaper (Fig. 2). The color of each analyzed indicator of a general clinical urine test on the reference graduated indicator strip corresponds to the qualitative or quantitative composition of the analyzed indicators of a general clinical urine test. The higher the concentration of the analyzed indicators of a general clinical urine test, the darker the color of the graduated indicator strip on the surface non-woven layer of the diaper becomes.

They focus on the color of each analyzed indicator of a general clinical urine analysis of a graduated indicator strip on the surface non-woven layer of the diaper and compare it with the color of each indicator of a reference graduated strip, draw a conclusion about the qualitative and quantitative composition of the patient’s urine, on the basis of which a decision is made on the need for additional diagnostic and therapeutic measures .

• pH: This test field contains a dual indicator that gives a wide range of colors in the pH range from 5.0 to 9.0 (orange (pH 5.0), yellow (pH 6.0-6.5), light green (pH 7.0-8.0) turquoise (pH 8.5-9.0) The indicator does not react to protein.

• Specific Gravity: This test field contains the detergent and indicator bromothymol blue, which reacts in the presence of ions contained in urine, changing color from blue to orange (violet 1.000, dark turquoise 1.005, dark green 1.010, green 1.015, light green - 1.020, light brown - 1.025, orange - 1.030). A reddish dye is impregnated in the test field, resulting in a yellow-brown color.

• Red Blood Cells: This buffered test field contains organic peroxidase and chromogen. The peroxidase activity of hemoglobin and myoglobin causes a green color (light yellow - negative test, light yellow with single splashes of green - 5-10 erythrocytes in the urine, light green with a small number of splashes of green - 25 erythrocytes in the urine, green with more the number of inclusions of green color - 50 erythrocytes in the urine, dark green - more than 250 erythrocytes).

• Leukocytes: This test field contains indoxyl ether and diazonium salts. Granulocyte esterase breaks down the ester, as a result of which free indoxyl can react with diazonium salts, giving a violet color (yellow - negative, beige - doubtful (±), pink - weakly positive (+), light purple - positive (++), dark purple - sharply positive (+++).

• Protein: This buffered test field is impregnated with a yellow indicator that turns green in the presence of protein. This color change is based on the "protein shift" of the pH indicator, particularly responsive to albumin. Light olive color - protein concentration in urine 0.1 g/l, olive color - protein concentration in urine 0.3 g/l, green color - protein concentration in urine 1.0 g/l, light emerald color - concentration protein in urine is 3.0 g/l, emerald color - protein concentration is more than 10 g/l.

• Glucose: This test is based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen peroxide with the oxidation of glucose. Yellow color - glucose concentration 0.0 mmol/l, light green - glucose concentration 2.8 mmol/l, light green - glucose concentration 5.6 mmol/l, green - glucose concentration 14.0 mmol/l, dark green - glucose concentration is 28.0 mmol/l, deep dark green - glucose concentration is more than 56.0 mmol/l.

• Ketone bodies: This test is based on the Legal method in which the test field contains glycine and sodium nitroprusside in an alkaline buffer. The presence of methyl ketones gives a violet color to the test field. Light beige - ketone concentration 0.0 mmol/l, beige - ketone concentration 0.5 mmol/l, beige-pink - ketone concentration 1.5 mmol/l, pink-sand - ketone concentration 4.0 mmol/l, light purple - ketone concentration 8.0 mmol/l, dark purple - ketone concentration more than 16.0 mmol/l.

• Nitrites: This test depends on the transformation of nitrates into nitrites by Gram+ bacteria in the urine. This buffered test field is impregnated with an amine and an activator. Nitrites present in urine react to diazotize the amine. The reaction that occurs gives a pink color. Pale yellow - the absence of nitrites in the urine, pink color - the presence of nitrites in the urine.

• Bilirubin: The test is based on the binding of bilirubin to diazonium salts in a strongly acidic environment. The intensity of the yellow-brown color is proportional to the concentration of bilirubin. Beige - absence of bilirubin in urine, sandy - bilirubin concentration 9.0 µmol/l, light brown - bilirubin concentration 17.0 µmol/l, powdery-sandy - bilirubin concentration 50.0 µmol/l.

• Urobilinogen: This test field contains stabilized diazonium salts and buffer. Urobilinogen interacts with the field, producing a pink to red color. Yellow - urobilinogen concentration 3.5 µmol/l, peach - urobilinogen concentration 17.5 µmol/l, orange-pink - urobilinogen concentration 35.0 µmol/l, pink - urobilinogen concentration 70 µmol/l, crimson - urobilinogen concentration 140 µmol /l, dark crimson - urobilinogen concentration more than 210 µmol/l.

Example 1.

Child, 6 months. Within two days there is anxiety, general weakness, loss of appetite, and an increase in body temperature to 38.5°C. On examination, there are no catarrhal symptoms: no hyperemia of the pharynx and mucous discharge from the nose. When using a diaper with an indicator strip, it was found that changes in the child’s urine indicate the presence of inflammation: leukocytes (dark purple color of the indicator strip, which is responsible for the presence of leukocytes in the urine, +++), nitrites (rich pink color of the indicator strip, responsible for the presence of nitrites in the urine), protein (rich dark green color of the indicator strip, responsible for the presence of protein in the urine), an increase in the specific gravity of urine to 1.025 (yellow color of the indicator strip, responsible for the specific gravity of urine). This analysis, carried out using a diaper with an indicator strip, made it possible to quickly suspect an infectious disease of the urinary system and make a decision in favor of additional research methods to make an accurate diagnosis. When conducting a general clinical urine test and a general clinical blood test in a hospital setting, signs of inflammation were confirmed using analyzers, a bacteriological blood test revealed a large number of E. coli bacteria, and an ultrasound of the kidneys showed an expansion of the pyelocaliceal system, which allowed, based on anamnesis, clinical examination and additional research methods to diagnose “Acute pyelonephritis”. Thus, early diagnosis of the inflammatory process in the urinary system made it possible to quickly make the correct diagnosis and prescribe the necessary therapy.

Example 2.

Patient, 67 years old, bedridden, with a history of stroke. Within two days, paroxysmal pain in the left hypochondrium, nausea, one-time vomiting, an increase in body temperature to 37.0 ° C were noted; during the last day, yellowness of the skin and sclera appeared. A general clinical urine test was performed at home using a diaper with an indicator strip. It was found that the urine contains an increased concentration of bilirubin (the indicator strip is colored rich yellow-brown, which is responsible for the presence of bilirubin in the urine). When analyzing the clinical symptoms and conducting a general clinical urine test using a diaper with an indicator strip, the local doctor suspected a pathology in the hepatobiliary system. The patient was sent to the hospital to clarify the diagnosis, where the presence of bilirubin in the urine was confirmed using an analyzer, and an ultrasound of the abdominal organs revealed a violation of the outflow of bile due to blockage of the bile ducts by a neoplasm. Rapid diagnosis made it possible to quickly make a diagnosis and choose further tactics for patient management.

2. Compare the number of vertical stripes of the indicator strip formed on the surface non-woven layer of the diaper with the number of vertical stripes of the graduated indicator strip supplied with the diaper (Fig. 3). The number of vertical stripes on the reference graduated indicator strip corresponds to the qualitative or quantitative composition of the analyzed indicators of general clinical urine analysis. The higher the concentration of the analyzed indicators of general clinical urine analysis, the more vertical stripes there are on the graduated indicator strip on the surface non-woven layer of the diaper.

They focus on the number of vertical stripes that appear for each analyzed indicator of a general clinical urine analysis of a graduated indicator strip on the surface non-woven layer of the diaper and compare it with the number of vertical stripes of each indicator of a reference graduated strip, draw a conclusion about the qualitative and quantitative composition of the patient’s urine, on the basis of which a decision is made on the need for additional diagnostic and therapeutic measures.

• pH: This test field contains a dual indicator that gives a wide range of pH from 5.0 to 9.0 (one strip (pH 5.0), two strips (pH 6.0-6.5), three strips (pH 7.0-8.0) four strips (pH 8.5-9.0).The indicator does not react to protein.

• Specific Gravity: This test field contains a detergent and bromothymol blue indicator that reacts in the presence of ions found in urine (one strip 1.000, two strips 1.005, three strips 1.010, four strips 1.015, five strips 1.020, six strips 1.025 and more).

• Red Blood Cells: This test field contains organic peroxidase and chromogen. The peroxidase activity of hemoglobin and myoglobin causes the appearance of indicators (one strip - a negative test, two strips - 5-10 red blood cells in the urine, three strips - 25 red blood cells in the urine, four strips - 50 red blood cells in the urine, five strips - more than 250 red blood cells).

• Leukocytes: This test field contains indoxyl ether and diazonium salts. Granulocyte esterase breaks down the ester, as a result of which free indoxyl can react with diazonium salts (one stripe - negative, two stripes - doubtful (+), three stripes - weakly positive (+), four stripes - positive (++), five stripes - strong positive (+++).

• Protein: This test field is impregnated with a yellow indicator, the presence of protein contributes to the appearance of the indicators. One strip - no protein, two strips - protein concentration in urine 0.1 g/l, three strips - protein concentration in urine 0.3 g/l, four strips - protein concentration in urine 1.0 g/l, five strips color - protein concentration in urine 3.0 g/l.

• Glucose: This test is based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen peroxide with the oxidation of glucose. One strip - glucose concentration 0.0 mmol/l, two strips - glucose concentration 2.8 mmol/l, three strips - glucose concentration 5.6 mmol/l, four strips - glucose concentration 14.0 mmol/l, five strips - glucose concentration is 28.0 or more mmol/l.

• Ketone bodies: This test is based on the Legal method in which the test field contains glycine and sodium nitroprusside in an alkaline buffer. One strip - ketone concentration 0.0 mmol/l, two strips - ketone concentration 0.5 mmol/l, three strips - ketone concentration 1.5 mmol/l, four strips - ketone concentration 4.0 mmol/l, five strips - ketone concentration 8.0 mmol/l or more.

• Nitrites: This test depends on the transformation of nitrates into nitrites by Gram+ bacteria in the urine. This buffered test field is impregnated with an amine and an activator. Nitrites present in urine react to diazotize the amine. One strip - the absence of nitrites in the urine, two stripes - the presence of nitrites in the urine.

• Bilirubin: The test is based on the binding of bilirubin to diazonium salts in a strongly acidic environment. One strip - absence of bilirubin in urine, two strips - bilirubin concentration 9.0 µmol/l, three strips - bilirubin concentration 17.0 µmol/l, four strips - bilirubin concentration 50.0 µmol/l.

• Urobilinogen: This test field contains stabilized diazonium salts and buffer. One strip - urobilinogen concentration 3.5 µmol/l, two strips - urobilinogen concentration 17.5 µmol/l, three strips - urobilinogen concentration 35.0 µmol/l, four strips - urobilinogen concentration 70 µmol/l, five strips - concentration urobilinogen 140 µmol/l and above.

Example 3.

Bedridden patient, 64 years old, diagnosed with type 1 diabetes mellitus. Due to increased stress, I felt weakness, dizziness, drowsiness, nausea, once - vomiting, and increased thirst. When conducting a general clinical urine test using a diaper, it was revealed that the glucose level was about 14 mmol/l (4 strips), and the level of ketones in the urine was around 4 mmol/l (4 strips), which made it possible to quickly diagnose diabetic ketoacidosis and carry out therapeutic procedures to relieve this condition.

Example 4.

A child, 5 months old, has an increase in body temperature to 37.1°C, frequent urination, crying when urinating. When conducting a general clinical analysis of urine using a diaper, the presence of leukocytes (4 strips), as well as nitrites in the urine (2 strips), was detected, which contributed to the correct diagnosis of urinary tract infection and the further prescription of timely and adequate antimicrobial therapy.

Thus, the proposed method is quite simple and informative, reduces the time for obtaining results of a general clinical urine test, which allows it to be used for the initial diagnosis of diseases of the urinary system and conditions characterized by changes in urine parameters, to assess the effectiveness of therapy, and reduces financial costs and time for the diagnosis of diseases of the urinary system in infants and bedridden patients.

Claims (2)

1. A method for conducting a general clinical analysis of urine using a diaper, which consists in placing a strip with reagents for conducting a general clinical analysis of urine in the absorbent layer of the diaper, the indicators of which are located in the non-woven surface layer, divided by an inactive non-woven material into ten equal signed parts: pH, specific gravity, red blood cells, white blood cells, protein, glucose, ketone bodies, nitrites, bilirubin, urobilinogen, pH test field contains dual indicator, specific gravity test field contains detergent and bromothymol blue indicator, buffered red blood cells test field contains organic peroxidase and chromogen, the test field for the determination of leukocytes contains indoxyl ether and diazonium salts, the buffered test field for the determination of protein is impregnated with a yellow indicator, the test field for the determination of glucose is based on a double sequential enzyme reaction, the test field for the determination of ketone bodies contains glycine with sodium nitropusside in an alkaline buffer, in a buffered test field for the determination of nitrites, an amine and an activator are impregnated, the test field for the determination of bilirubin contains diazonium in a strongly acidic medium, the test field for the determination of urobilinogen contains stabilized diazonium salts and a buffer, when the patient’s urine interacts with the reagents, a chemical reaction occurs, accompanied by a change in the color of the reagents depending on the qualitative and quantitative composition of the indicators of a general clinical urine analysis; on the surface non-woven layer of the diaper, each of the ten parts of the indicator strip changes color depending on the qualitative and quantitative composition of the analyzed indicators of a general clinical urine analysis; compare the color change of the indicator strip with the colors of the reference graduated indicator strip supplied with the diaper, the color of each analyzed indicator of a general clinical urine analysis on the reference graduated indicator strip corresponds to the composition of the analyzed indicators of a general clinical urine analysis; the higher the concentration of the analyzed indicators of a general clinical urine analysis, the more color the indicator graduated strip on the surface non-woven layer of the diaper becomes dark or another color, compare the color of the indicator strip with the color of each indicator of the reference graduated strip - test field for determining pH: orange pH 5.0, yellow pH 6.0-6.5, light green pH 7.0-8.0, turquoise pH 8.5-9.0; test field for determining specific gravity: purple - 1.000, dark turquoise - 1.005, dark green - 1.010, green - 1.015, light green - 1.020, light brown - 1.025, orange - 1.030; test field for determining red blood cells: light yellow - negative test, light yellow with single splashes of green - 5-10 red blood cells in the urine, light green with a small number of splashes of green - 25 red blood cells, green with a large number of splashes of green - 50 red blood cells in the urine, dark green - more than 250 red blood cells; test field for determining leukocytes: yellow - negative, beige - doubtful, pink - weakly positive, light purple - positive, dark purple - strongly positive; test field for determining proteins: light olive color - protein concentration in urine 0.1 g/l, olive color - protein concentration in urine 0.3 g/l, green color - protein concentration in urine 1.0 g/l, light emerald color - protein concentration in urine is 3.0 g/l, emerald color - protein concentration in urine is more than 10 g/l; test field for determining glucose: yellow - glucose concentration 0.0 mmol/l, light green - glucose concentration 2.8 mmol/l, light green - glucose concentration 5.5 mmol/l, green - glucose concentration 14.0 mmol/l, dark green - glucose concentration 28.0 mmol/l, deep dark green - glucose concentration 56.0 mmol/l; test field for determining ketone bodies: light beige - ketone concentration 0.0 mmol/l, beige - ketone concentration 0.5 mmol/l, beige-pink - ketone concentration 1.5 mmol/l, pink-sand - ketone concentration 4.0 mmol/l, light purple - ketone concentration 8.0 mmol/l, dark purple - ketone concentration more than 16.0 mmol/l; test field for determining nitrites: pale yellow - absence of nitrites in urine, pink color - presence of nitrites in urine; test field for determining bilirubin: beige - absence of bilirubin in urine, sandy - bilirubin concentration 9.0 µmol/l, light brown - bilirubin concentration 17.0 µmol/l, powdery sand - bilirubin concentration 50.0 µmol/l; test field for determining urobilinogen: yellow - urobilinogen concentration 3.5 µmol/l, peach - urobilinogen concentration 17.5 µmol/l, pink - urobilinogen concentration 70 µmol/l, crimson - urobilinogen concentration 140 µmol/l, dark crimson - urobilinogen concentration is 210 µmol/l, a conclusion is drawn about the qualitative and quantitative composition of the patient’s urine, and a decision is made on the need for additional diagnostic and therapeutic measures. 2. A method for conducting a general clinical analysis of urine using a diaper, which consists in placing a strip with reagents for conducting a general clinical analysis of urine in the absorbent layer of the diaper, the indicators of which are located in the non-woven surface layer, divided by an inactive non-woven material into ten equal signed parts: pH, specific gravity, red blood cells, white blood cells, protein, glucose, ketone bodies, nitrites, bilirubin, urobilinogen, pH test field contains dual indicator, specific gravity test field contains detergent and bromothymol blue indicator, buffered red blood cells test field contains organic peroxidase and chromogen, the test field for the determination of leukocytes contains indoxyl ether and diazonium salts, the buffered test field for the determination of protein is impregnated with a yellow indicator, the test field for the determination of glucose is based on a double sequential enzyme reaction, the test field for the determination of ketone bodies contains glycine with sodium nitropusside in an alkaline buffer, in a buffered test field for the determination of nitrites, an amine and an activator are impregnated, the test field for the determination of bilirubin contains diazonium in a strongly acidic medium, the test field for the determination of urobilinogen contains stabilized diazonium salts and a buffer, when the patient’s urine interacts with the reagents, a chemical reaction occurs, accompanied by the appearance of vertical stripes on the surface non-woven layer of the diaper in each area of the analyzed indicator, compare the number of vertical stripes of the indicator strip with the number of vertical stripes of the reference graduated indicator strip supplied with the diaper; the higher the concentration of the analyzed indicators of general clinical urine analysis, the more vertical stripes of the graduated indicator strip strips on the surface non-woven layer of the diaper, test field for determining pH: one strip pH 5.0, two strips pH 6.0-6.5, three strips pH 7.0-8.0, four strips pH 8.5-9 ,0; test field for determining specific gravity: one strip - 1.000, two strips - 1.005, three strips - 1.010, four strips - 1.015, five strips - 1.020, six strips - 1.025 or more; test field for determining red blood cells: one strip - negative test, two flats - 5-10 red blood cells in the urine, three strips - 25 red blood cells, four strips - 50 red blood cells in the urine, five strips - 250 red blood cells or more; test field for determining leukocytes: one strip - negative, two stripes - doubtful, three stripes - weakly positive, four stripes - positive, five stripes - strongly positive; test field for determining proteins: one strip - no protein, two strips - protein concentration in urine 0.1 g/l, three strips - protein concentration in urine 0.3 g/l, four strips - protein concentration in urine 1.0 g/l, five stripes - protein concentration in urine 3.0 g/l or more; test field for determining glucose: one strip - glucose concentration 0.0 mmol/l, two strips - glucose concentration 2.8 mmol/l, three strips - glucose concentration 5.6 mmol/l, four strips - glucose concentration 14.0 mmol/l, five strips - glucose concentration 28.0 mmol/l or more; test field for determining ketone bodies: one strip - ketone concentration 0.0 mmol/l, two strips - ketone concentration 0.5 mmol/l, three strips - ketone concentration 1.5 mmol/l, four strips - ketone concentration 4, 0 mmol/l, five strips - ketone concentration 8.0 mmol/l or more; test field for determining nitrites: one strip - the absence of nitrites in the urine, two flats - the presence of nitrites in the urine; test field for determining bilirubin: one strip - absence of bilirubin in urine, two strips - bilirubin concentration 9.0 µmol/l, three strips - bilirubin concentration 17.0 µmol/l, four strips - bilirubin concentration 50.0 µmol/l; test field for determining urobilinogen: one strip - urobilinogen concentration 3.5 µmol/l, two strips - urobilinogen concentration 17.5 µmol/l, three strips - urobilinogen concentration 70 µmol/l, four strips - urobilinogen concentration 140 µmol/l, five strips - urobilinogen concentration 210 µmol/l, make a conclusion about the qualitative and quantitative composition of the patient’s urine, decide on the need for additional diagnostic and therapeutic measures.