Specification :

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.
SUMMARY
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. The Urinalysis Reagent Strips ( Urine) can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.1, 2
PRINCIPLE AND EXPECTED VALUES
Ascorbic acid: This test involves decolorization of Tillmann’ s reagent. The presence of ascorbic acid causes the color of the test field to change from blue-green to orange.
Glucose: This test is based on the enzymatic reaction that occurs between glucose oxidase, peroxidase and chromogen. Glucose if first oxidized to produce gluconic acid and hydrogen peroxide in the presence of glucose oxidase. The hydrogen peroxide reacts with potassium iodide chromogen in the presence of peroxidase. The extent to which the chromogen is oxidized determines the color which is produced, ranging from green to brown. Low amounts of glucose are normally excreted in urine.3 Glucose concentrations as low as 100 mg/ dL, read at either 10 or 30 seconds, may be considered abnormal if results are consistent. At 10 seconds, results should be interpreted qualitatively. For semi-quantitative results, read at 30 seconds only.
Bilirubin: This test is based on azo-coupling reaction of bilirubin with diazotized dichloroaniline in a strongly acidic medium. Varying bilirubin levels will produce a pinkish-tan color proportional to its concentration in urine. In normal urine, no bilirubin is detectable by even the most sensitive methods. Even trace amounts of bilirubin require further investigation. Atypical results ( colors different from the negative or positive color blocks shown on the color chart) may indicate that bilirubin-derived bile pigments are present in the urine specimen, and are possibly masking the bilirubin reaction.