Visual test strips 'Uripolian -1 he' (Urigem) # 50

PURPOSE

Indicator test strips Uripolian-1he are intended for qualitative and semi-quantitative determination of blood (free hemoglobin) in urine in medical institutions, as well as at home (for express analysis of in vitro diagnostics).

Applications - self-testing, clinical laboratory diagnostics, clinical medicine, emergency express diagnostics.

Qualitative and semi-quantitative determination of blood (free hemoglobin) in urine is used as an auxiliary method, which makes it possible to control the level of urine according to the above analyte (parameter), as well as monitor the course of treatment of many pathologies, including the kidneys and urinary tract.

Urine is the end product of the kidneys, which is one of the main components of metabolism and reflects the state of blood and metabolism.

It contains water, metabolic products, electrolytes, trace elements, hormones, desquamated tubule cells and urinary tract mucosa, leukocytes, salts, mucus.

The set of physical and chemical parameters of urine, as well as the analysis of the content of various metabolic products in it, makes it possible to assess not only the function of the kidneys and urinary tract, but also the state of some metabolic processes, as well as to identify violations in the work of internal organs.

Blood / hemoglobin:

Hemoglobin and myoglobin catalyze the oxidation reaction of the chromogen contained in the sensor element of the Test strip, due to organic peroxides. Spotted coloration or the appearance of green dots and spots on the sensor element indicate the presence of intact (whole) erythrocytes (in this case, the approximate threshold of sensitivity is 10.0 eri / Ојl, which approximately corresponds to the content of 0.3 mg of hemoglobin or myoglobin in 1 liter of urine ). The more dots and spots on the sensory element, the more intact erythrocytes. Therefore, the second color scale is given, as a kind of mock-up for the correct interpretation of the appearance of dots and spots on the sensor element. The presence of hemoglobin, hemolyzed erythrocytes and myoglobin in the urine indicates uniform staining of the sensory element. The test is equally sensitive to hemoglobin,and to myoglobin. The threshold of sensitivity for the presence of hemoglobin is 10.0 erythrocytes in 1 microliter of urine (eri / Ојl) or 0.3 mg / l. High concentrations of nonspecific oxygen acceptors, such as ascorbic acid, gentisic acid, glutathione, etc., can reduce the sensitivity of the test. Inflated or false positive results can be caused by insufficient cleanliness of the urine collection container, as well as with traces of detergents and disinfectants.Inflated or false positive results can be caused by insufficient cleanliness of the urine collection dishes, as well as with traces of detergents and disinfectants.Inflated or false positive results can be caused by insufficient cleanliness of the urine collection container, as well as with traces of detergents and disinfectants.

Test strips are intended for in vitro diagnostics.

Test strips are for single use only.

Potential risk class - 2a.

DEFINITION

To determine, use freshly collected (no more than 2 hours before analysis) urine in a clean dish, not centrifuged and thoroughly mixed.

1. Control at a temperature (+ 15� + 30 ° С).

2. Open the case or open the bag, remove the test strip from it.

If the test strips are packaged in a pencil case, immediately close the lid tightly.

3. Submerge the test strip sensor (s) completely in the urine.

4. After 2-3 seconds, remove the Test Strip and remove the excess urine on the sensor (s) by gently touching the edge of the strip to clean filter paper (clean paper towel, paper towel, toilet paper, etc.) for 2 -3 seconds.

5. Place the test strip on a flat, dry surface with the sensor element (s) facing up.

6. After 1 minute from the moment of immersion of the sensory element (s) in urine, compare its color with the corresponding color scale in good light.

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Registration of the obtained analysis results can be carried out visually.

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Do not compare the color of the sensor element with the color scale in direct sunlight.

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During the test, do not touch the sensor elements of the Test Strip with your hands.

A change in the color of any sensory element (s) indicates the presence of one of the analytes (parameters) in the urine (qualitative determination).

Semi-quantitative determination is carried out by comparing the color of the sensor (s) element (s) with the corresponding color scales.

The label contains color scales, consisting of a number of color fields, next to each of which the concentration of the corresponding analyte (parameter) is indicated.

Changes in color, which can only occur at the edges of the sensory area (edging), are not diagnostic.

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Strict adherence to the instructions for use is essential to obtain reliable results!

CONDITIONS OF STORAGE, OPERATION AND DISPOSAL OF THE PRODUCT

Test strips should be stored in the manufacturer's packaging in a dry place at temperatures up to 30 В° C (in the absence of acid, alkali and organic solvent vapors) for the entire shelf life of 24 months.

Biochemical research of water should be carried out at a temperature of + 10- + 35 В° C.

Improper storage and use will result in the loss of functionality of the test strips.

Keep out of the reach of children.

It is necessary to protect the indicator strips from high humidity and direct sunlight.

Avoid direct sunlight on the color scale.

Each indicator strip is designed for one determination.

After opening the case, the indicator strips should be used within no more than 5 months.

The test strip taken out of the package should be used for analysis within 15 minutes.

Do not use after the expiration date.

In case of testing after use, all components and packaging should be thrown into the waste container.

Specifications

Amount in a package

fifty

Manufacturer country

Russia

Brand name

Biosensor AN OOO

A type

Test strips

Package weight, g

thirty