Urinalysis Reagent Strips (Urine) Package Insert

Urinalysis Reagent Strips (Urine) Package Insert

1. Urine undergoes many changes during states of disease or body dysfunction before blood composition is altered to a significant extent. Urinalysis is a useful procedure as an indicator of health or disease, and as such, is a part of routine health screening

2. INTENDED USE: The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the detection of one or more of the following analytes in urine: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes.

3. PRINCIPLE AND EXPECTED VALUES. Glucose: This test is based on the enzymatic reaction that occurs between glucose oxidase, peroxidase and chromogen. Nitrite: This test depends upon the conversion of nitrate to nitrite by the action of Gram negative bacteria in the urine

   • Bilirubin: This test is based on azo-coupling reaction of bilirubin with diazotized dichloroaniline in a strongly acidic medium.
   • Blood: This test is based on the peroxidase-like activity of hemoglobin which catalyzes the reaction of cumene-hydroperoxide and 3,3',5,5'-tetramethylbenzidine.
   • pH: This test is based on a double indicator system which gives a broad range of colors covering the entire urinary pH range
   • Urobilinogen: This test is based on a modified Enhrlich reaction between p-diethylaminobenzaldehyde and urobobilinogen acid in strongly acidic medium to produce a pink color
   • Leukocytes: This test reveals the presence of granulocyte esterases. The esterases cleave a derivatized pyrazole amino acid ester to liberate der

4. PRECAUTIONS • For in vitro diagnostic use only. Do not use after the expiration date. • The strip should remain in the closed canister until use. • Do not touch the reagent areas of the strip. • Discard any discolored strips that may have deteriorated. • All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. • The used strip should be discarded according to local regulations after testing.

5. DIRECTIONS FOR USE Allow the strip, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing. 1. Remove the strip from the closed canister and use it as soon as possible. Immediately close the canister tightly after removing the required number of strip(s). 2. While removing the strip from the urine, run the edge of the strip against the rim of the urine container to remove excess urine. Hold the strip in a horizontal position and bring the edge of the strip into contact with an absorbent material (e.g. a paper towel) to avoid mixing chemicals from adjacent reagent areas and/or soiling hands with urine. 3. Compare the reagent areas to the corresponding color blocks on the canister label at the specified times. Hold the strip close to the color blocks and match carefully. . Note: Results may be read up to 2 minutes after the specified times.

6. QUALITY CONTROL For best results, performance of reagent strips should be confirmed by testing known positive and negative specimens/controls whenever a new test is performed, or whenever a new canister is first opened. Each laboratory should establish its own goals for adequate standards of performance.

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