Combur⁹ Test Cobas

Combur⁹ Test Cobas

1. Intended use

   • Nine‑patch test strip for the semi‑quantitative determination of leukocytes, nitrite, pH, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by visual reading. For professional use only.

2. Summary

   • Urine test strips are used to measure certain constituents in urine which are significant of renal, urinary, hepatic and metabolic disorders.

3. Test principle

   • Leukocytes (LEU): The test reveals the presence of granulocyte esterases. These esterases cleave an indoxyl ester, and the indoxyl so liberated reacts with a diazonium salt to produce a violet dye. Bacteria, trichomonads or erythrocytes present in the urine do not affect the reaction.
   • Nitrite (NIT): The test is based on the principle of the Griess test and is specific for nitrite. The reaction reveals the presence of nitrite and hence indirectly nitrite-forming bacteria in the urine by a pink-to-red coloration of the test patch. Even a slight pink coloration is indicative of significant bacteriuria.
   • pH: The test paper contains the indicators methyl red, phenolphthalein and bromothymol blue and reacts specifically with H + -ions. The most frequent pH values of fresh urine from healthy subjects lie between 5 and 6.
   • Protein (PRO): The test is based on the principle of the protein error of a pH indicator. It is particularly sensitive to albumin. Quinine, quinidine, chloroquine, tolbutamide and an elevated pH (up to 9) do not affect the test.

4. Precautions and warnings

   • For in vitro diagnostic use. Exercise the normal precautions required for handling all laboratory reagents. Disposal of all waste material should be in accordance with local guidelines. Safety data sheet available for professional user on request. The stopper of the test strip vial contains a non-toxic silicate-based desiccant which must not be removed. If ingested by accident, drink large quantities of water.

5. Assay For optimum performance

   • 1. Use fresh urine that has not been centrifuged. Thoroughly mix the urine sample. The sample should be at room temperature when the test is performed and should not have been standing for more than 2 hours
   • 2. Take a test strip out of the container. Close the container again with the original desiccant stopper immediately after removal of the strip. This is important as otherwise the test areas may become discolored due to environmental influences such as moisture or nitrite gases in the air. Incorrect results may be obtained.
   • 3. Briefly (about 1 second) dip the test strip into the urine making sure that all test areas are moistened.
   • 4. When withdrawing the test strip, wipe the edge against the rim of the vessel to remove excess urine
   • 5. After 60 seconds (60-120 seconds for the leukocyte test area), compare the reaction colors of the test areas with the colors on the label and assign always the value of the nearest color block.

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