Manufacturers of Thermometers, Exporters of Digital Thermometers, Suppliers of Thermometers in India, Indian Manufacturers of Medical Equipments, Hicks Thermometers (INDIA) Ltd.

LIMITATION
As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single test result or method.

STORAGE
Do not remove desiccants from the bottle. Store at room temperature (2-30°C). Store the bottle out of direct sunlight. Do not use after expiry date. Do not touch any reagent area.

REGEANT AREA INFORMATION

Leukocytes
Normal urine specimens generally yield negative results; positive results are clinically significant. Individually observed “Trace” results may be of questionable clinical significance; however ”Trace” results observed repeatedly may be clinically significant. “Positive” results may occasionally be found with random specimens from females due to contamination of the specimen by vaginal discharge. Higher glucose concentration (166mmol/L) or high specific gravity may cause decreased test results. The presence of cephalexin, cephalothin or high concentrations of oxalic acid may also cause decreased test results. Tetracycline may cause decreased reactivity and high levels of that drug may cause a false negative reaction. Nitrofuration gives a brown color to the urine that may mask the color reaction on the reagent pad. Any substance that causes abnormal urine color may obscure the color reaction.

Nitrite
This test is specific for nitrite in urine. Pink spots or pink edges should not be interpreted as a positive re
sult. Any degree of uniform pink color development should be interpreted as a positive nitrite test, suggesting the presence of 1 ~ or more organisms per ml. but color development Is not proportional to the number of bacteria present. A negative result does not prove that there is no significant bacteriuria. Prolonged urinary retention in bladder (4-8 hours) is essential in order to obtain an accurate result; or lest is reduced for urine with high specific gravity. Ascorbic acid concentrations of 1.42 mmol/L or greater may cause false negative results with specimens containing small amounts of nitrite ion (13µmol/L or less).

Urobilinogen
A result of 3.3µmol/L represents the transition from normal to abnormal, and the patient and/or urine specimen should be evaluated further. The reagent area may react with substances known to interfere with Ehrlich’s reagent, such as p-aminosalicylic acid and sulphonamides. Atypical color reactions may be obtained in the presence of high concentrations of paminobenzoic acid. False negative results may be obtained if formalin is present. Highly colored substances, such as azo dyes and riboflavin may mask color development on the test area. Strip reactivity increases with temperature; the optimum temperature is 22-26°C. The absence of urobilinogen cannot be determined with the test.

Protein
The reaction is extremely sensitive to albumin. A ”Negative” result does not rule out the presence of other proteins. Normally no protein is detectable in urine by conventional methods although a minute amount is excreted by the normal kidney. A color matching any block greater than “Trace” indicates significant proteinuria. For urine of high specific gravity, highly buffered or alkaline urine, the lest area may most closely match the “Trace” color block even though only normal concentrations of protein are present. Further evaluation is needed or “Trace” results. False positive results may also be obtained by contamination of the urine specimen with quatemary ammonium compounds or chilorhexidin based disinfectants.

pH
The pH area measures pH value range of 5-8.5 visually and 5-8.5 instrumentally.

Blood
The significance of the “Trace” reaction may vary among patients, and clinical judgment is required for assessment in each individual case. Development of green spots or green color on the reagent area within 60 seconds indicates the need for further investigation. Blood is often found in the urine of menstruating females. This test is highly sensitive to hemoglobin and thus complements the microscopic examination. The test is equally sensitive to myoglobin as !o hemoglobin. Higher specific gravity or captopril may reduce the reactivity of the blood test. Certain oxidizing contaminants, such as hypochloritle or microbial perioxidase associated with urinary tract infection may produce false positive results.

Specific Gravity
This test reflects the ion concentration of urine and correlates well with the refractometric method. If pH is equal to or greater than 6.5, then add 0.005 to SG obtained. Instrumental readings are automatically adjusted for pH by the instrument. The test is affected neither by certain nonionic urine constituents such as glucose nor by the presence of radiopaque dye. Highly buffered alkaline urines may cause low readings relative to other methods. Higher specific gravity readings may be obtained in the presence of moderate quantities (1 -7.5g/L) of protein.

Ketones
The test reads with acetoacetic acid in urine. It does not react with acetone or ß-hydroxybutyric acid. Some high specific gravity/low pH urine may give reactions up to and including “Trace”. Clinical judgment Is needed to determine “Trace” results. Normal urine specimens usually yield negative results. Detectable levels of ketone may occur in urine during physiological stress conditions such as fasting, pregnancy and frequent strenuous exercise. In ketoacidosis, starvation or with other abnormalities of carbohydrate or lipid metabolism, ketones may appear in the urine in large amounts before serum ketone is elevated. False positive results (Trace) may occur with highly pigmented urine specimens or those containing large amounts of levodopa metabolites, Compounds such as Mesna that contain sulfhydryl groups may cause false positive results or an atypical color reaction.

Bilirubin
Normally no bilirubin Is detected In the urine by even me most sensitive methods. Even trace amounts of bilirubin are sufficiently abnormal to require further investigation. Atypical colors may indicate that bilirubin-derived bile pigments are present in the urine sample end may be masking the bilirubin reaction. These colors may indicate the urine specimen should be tested further. Indican (indoxyl sulfate) can, produce a yellow-orange to red color response which may interfere with the bilirubin reading. Ascorbic acid concentrations of 1.4 mmol/L or greater may cause false negatives.

Glucose
The test is specific for glucose. In dilute urines containing less than 0.28mmolIL ascorbic arid, as little as 2-2mmol/L. of glucose, may produce a color change that might be interpreted as positive. Ascorbic concentrations of 2.84mmol/L or greater and/or high ketone concentrations (4mmol/L) may give false negatives for specimens containing small amount of glucose (4-7mmol/L). The reactivity may also vary with temperature. Small amount of glucose is normally excreted by the kidney. These amounts are usually below me sensitivity of this test, bill no occasion may produce a color between the “Negative” and the 5.5mmol/L color blocks and that is interpreted by the instrument as positive.

Ascorbic Acid
The test is based on the principle of Tillman’s reagent. Ascorbic avid can reduce indicator and cause color changing, from blue into orange. This test can be used to determine ascorbic cod concentration in sample and decide ascorbic acids interference.

SPECIFIC CHARACTERISTICS
In clinical specimens, the sensitivity depends upon several factors; the variability of color perception, specific gravity, pH, and the lighting conditions when the product is read visually. Each color block or instrumental display value represents range of values. Because of specimen and reading variability, specimens with analytic concentrations that tall between two levels may give results at either level. Exact, agreement between visual results and instrumental results may not be found because of the inherent differences between the perception of the human eye and the optical system of the instruments.

The following table lists the generally delectable levels of analyses in contrived urine; however, concentrations may be detected under certain conditions: