URO-DIP 10e

URO-DIP 10e

1. SUMMARY AND EXPLANATION

   • Uro-dip Reagent Strips are dip-and-read test strips for In Vitro Diagnostic Use only for testing above items in urine. Test result may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and urinary tract infection

2. CHEMICAL PRINCIPLES OF PROCEDURE AND INGREDIENTS:

   • Specific gravity
     • The test is based on the principle of ion exchange, which runs between polyelectrolyte and ions present in urine. Its result is colour change of acid-base indicator from blue-green colour in urine with low concentration of ions, through green and yellow-green in urine with increased concentration of ions, to umber yellow colour. Using this test it is possible to determine specific gravity of urine in the range of 1.000 up to 1.030. The first morning urine of healthy person should be in the range of 1.015 up to 1.025.
   • Leucocytes: The test is based on enzymatic reaction. The test pad contains an indoxyl ester, that is cleaved by granulocyte esterases. The released indoxyl reacts with a diazonium salt and pink or violet coloration is formed.
   • Nitrite - The test is based on conversion of nitrate to nitrite by the action of certain species of bacteria contained in urine. The colour test is based on the principle of the Griess test. Some degree of pink coloration should be interpreted as a positive nitrite test suggestive of 105 or more organisms in 1 ml of urine specimen
   • pH - The test is based on the double indicator principle and gives a range of colours from orange through yellow and green to blue and permits differentiation to within 0.5 pH unit in the range pH 5 to 9.
   • Protein - The test is based on colour change of acid-base indicator, which is caused by presence of proteins. It is particularly sensitive to albumin, but is much less sensitive to globulin, mucoprotein, haemoglobin and Bence-Jones protein.
   • Glucose - The test is based on the specific glucose oxidase/peroxidase reaction and is specific for D-glucose. The reagent pad does not react with other sugars, it reacts with presence of D-glucose by greeny to dark-green coloration.
   • Ketones - The test is based on the principle of Legal‘s test and is more susceptible to acetoacetic acid than to acetone. Test does not react with ß-hydroxybutyric acid. The colour scale is calibrated for acetoacetic acid
   • Blood - The test is based on the peroxidase activity of haemoglobin which catalyzes the oxidation of the indicator due to the presence of the organic hydroperoxide contained in the diagnostic pad. The label contains two colour scales; for detection of intact erythrocytes and free haemoglobin. The test is highly sensitive to free haemoglobin and may detect its presence from concentrations corresponding approx. to 5 Ery/μl.

3. OBJECTIVE TEST PROCEDURE:

   • 1) Remove only as many test strips as are required, and reseal the tube immediately after use.
   • 2) Do not touch test pads of the strips.
   • 3) Completely immerse all reagents pads in specimen (no longer than 1-2 sec.)
   • 4) Run edge of the strip againts rim of urine container to remove excess urine. Hold the strip in horizontal position
   • 5) Evaluate the result using the reader Uro-dipcheck® 240e or Uro-dipcheck® 400e, follow enclosed instructions for that instruments
   • Notes: For visual evaluation compare the tests pads to the corresponding colour scale on the label after approx. 60 sec. and for leucocytes after 120 sec. According to the different spectral sensitivity of the human eye and the optical system it is not possible to guarantee the exact correspondence between visual reading and reading by analysers

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