For rapid detection of multiple analytes in human urine. For professional in vitro diagnostic use only.
The Reactif 11M urinalysis strips are solid plastic strips on which multiple, separated reagent fields are applied. The test is for the qualitative and semi-quantitative detection of the following analytes in urine: ascorbic acid, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes. The Reactif urinalysis strips are intended for single use at sites close to the patient (point of care) and central laboratories.
The cardboard label lists the respective analytes - compare the corresponding analyte with the fields on the colour scale. The Reactif urinalysis strips can be read optically as well as evaluated with the help of the urinalysis device and are intended for professional use only.
In the course of an illness or when the body is malfunctioning, urine undergoes many changes before the blood composition changes to a clearly recognisable extent. Urinalysis is a useful procedure as an indicator of health or disease, and as such is used in routine health screening. The Reactif urinalysis strip can be used in the determination of general health and helps in the diagnosis and monitoring of metabolic or systemic diseases affecting renal function, endocrine disorders and urinary tract diseases or disorders.
The presence of ascorbic acid causes the test field to change colour from blue-green to orange. Patients who eat an adequate diet excrete 2-10 mg/dL daily. After ingestion of large amounts of ascorbic acid, values can reach around 200 mg/dL.
No bilirubin is detectable in normal urine, even with the most sensitive methods. Even traces of bilirubin in urine require further investigation. Atypical results (colour deviations from the negative or positive colour fields on the colour scale) may indicate that biliary pigments derived from bilirubin are present in the urine sample and may mask the bilirubin reaction.
Blood is often found in the urine of women during menstruation. The significance of detected traces may vary depending on the patient and clinical judgement is required with these samples.
Glucose should not be detectable in normal urine. Small amounts of glucose may be excreted by the kidney. Glucose concentrations that continuously exceed 100 mg/dL are considered abnormal.
Ketones are not normally present in urine. Detectable ketone concentrations may occur in the urine due to physiological stress conditions such as dieting, pregnancy and exercise. During starvation or other abnormal carbohydrate metabolism, extremely high urinary ketone concentrations may occur before serum ketones are elevated.
This test indicates the presence of granulocyte esterases. Normal urine samples usually give negative results. Trace results may be of questionable clinical significance. If trace results occur, it is recommended to repeat the test with a fresh sample from the same patient. Repeated trace results and positive results are of clinical significance.
Nitrite is not detectable in normal urine. The nitrite range is positive in some infections, depending on the length of time the urine has been in the bladder prior to collection. Positive cases found with the nitrite test range from as low as 40% in cases with little urine retention time in the bladder to as high as about 80% in cases with at least 4 hours of urine retention time in the bladder.
The expected range for normal urine samples from newborns is pH 5-7. For other normal urine samples, the expected range is pH 4.5-8, with pH 6 as the average result.
Colours range from yellow to yellow-green for negative results and from green to green-blue for positive results. From a normal kidney, 1-14 mg/dL of protein can be excreted. Significant proteinuria is indicated when a colour is assigned to any colour field indicating more than trace. Clinical judgement is required to assign significance to detected traces.
In the presence of an indicator, colours range from dark blue-green for urine with low ion concentration to green and yellow-green for urine with increased ion concentration. For randomly collected urine, the specific gravity can vary from 1.003-1.035 g/mL. 24-hour urine from healthy adults with normal diet and fluid intake has a specific gravity of 1.016-1.022 g/mL. In cases with severe kidney damage, the specific gravity is 1.010 g/mL, the value of the glomerulus filtrate.
Urobilinogen is one of the main compounds formed during haem synthesis and is normally found as a substance in urine. For normal urine, the expected range for this test is 0.2-1.0 mg/dL (3.5-17 μmol/L). A result of 2.0 mg/dL (35 μmol/L) may be of clinical significance and the patient sample should then be investigated further.