QUICKLY TEST UTITEST 5V ™

Urine test strips with 5 key indicators to check kidney and urinary function.

Intended Use

Please read this information before use

Intended use

Utitest 5V urine reagents strips provide a quick way to test for leucocytes, pH , Protein, nitrites and blood in the urine. The greater the number of positive results , the stronger the indication of urinary tract infection , with a positive protein result indicating possible kidney involvement. The advantage of the Quicklytest UTI TEST 5V is that all five indicators of a possible urinary tract infection are present , minimizing any confusion caused by the presence of false positives or false negatives. The test is intended primarily for use by health care professionals, but can also be used for self testing at home. Positive results should generally be followed up by lab cultures and all concerns discussed with a doctor or a pharmacist.

Test principles and limitation

Leucocytes: the test reveals the presence of granulocyte esterases. These esterases leave an indoxyl ester and the indoxyl so liberated reacts with a diazonium salt to produce a violet komplex.

Leucocyte esterase results may be positive in the absence of observable cells if the leucocytes have lysed. Positive results may occasionally be found with random specimens from females due to contamination of the specimen by vaginal discharge. Elevated glucose concentrations or high specific gravity may cause decreased test results. The presence of cephalexin , cephalothin, or tetracycline may cause decreased reactivity and high levels of the drug of the drug may cause a false negative reaction. The test area does not react with lymphocytes.

Nitrites: The test is based on the principle of Griess’s test and is specific to nitrites. Any degree of uniform pink colour development should be interpreted as a positive.

Positive results of the nitrites test suggests the presence of 100.000 or more organisms per ml of urine but colour development is not proportional to the number of bacteria present. A negative result does not in itself prove that there is no significant bacteriuria. Negative results may occur when urinary tract infections are caused by organisms that do not contain reductase to convert nitrate to nitrite or when urine has not been retained in the bladder long enough ( 4 – 8 hours ) for the reduction of nitrate to occur or when dietary nitrate is absent , even if organisms containing reductase are present and bladder incubation is ample. Ascorbic acid concentrations of 2,8 mmol/lit or greater may cause false negative results with specimens containing nitrite ion concentrations of 35 mikromol/l or less.

Protein: The test is based on the principle of the protein error of a pH indicator.

The reagent area is sensitive to albumin. An elevated pH up to 9 may affect the test.

If the residue of the disinfectant containing quaternary ammonium groups or chlorhexidine is present in the urine collection container, this may lead to a false positive result.

pH: This test contains a mixed indicator which assures a marked change in colour between pH 5 and pH 8,5. It may be necessary to repeat this test a number of times with a space of three hours between tests to determine the prevailing pH. High or low pH may indicate presence of bacteriuria.

Blood: Haemoglobin and myoglobin catalyze the oxidation of the indicator by means of organic hydroperoxide contained in the test paper.

The test is highly sensitive to haemoglobin and thus complements microscopic examination. The sensitivity of this test may be reduced in urine with high specific gravity. The test is equally sensitive to myoglobin as to haemoglobin. Captopril and Lodine may also cause decreased reactivity.Blood is often found in the urine of menstruating females. Certain oxidizing contaminants such as hypochlorite may produce false positive results.Microbial peroxidase associated with urinary tract infection may cause false negatives at the trace levels.

Sensitivity and range

Sensitivity is dependent upon the presence or absence of interfering specimens

Item
Leucocytes
Nitrite
Protein
pΗ
Blood

Sensitivity
15 – 40 cells mikrol granulocyte
13 – 22
0,10 0,15 g / L Albumin
0,5 pH unit
0,15 – 0,6 mg / L haemoglobin

Range
Negative 500 cells mikrol
Negative – positive
Negative – 5,0 g / L
PH 5 – 8,5
Negative 200 cells / mikrol

Precautions

Handling:

Use a clean container to collect urine. False positive readings for Blood can result from residues of strongly oxidizing disinfectants in the specimen collection container.

Operation:

2.Incorrect results may be obtained when you shake the strip in specimen container. Dip for approx. two seconds. If the dipping time is too short or too short the results may be unpredictable.

Specimen collection and preparation

Collect urine in a cleand container and test as soon as possible. If testing cannot be performed within one hour after voiding , refrigerate the specimen immediately. Allow refrirated specimen to return to room temperature before testing.

Test procedure

Remove one strip from the bottle at a time and replace cap tightly.
Completely immerse reagent areas of the strip in fresh urine. Remove the strip to avoid the dissolving out of reagent areas.
While removing , tap the strip against the rim of the urine container to remove excess urine.
Blot the urine strip on a long edge on absorbent paper.
Compare each reagent area to its corresponding colour blocks, shown on the colour chart and read at the times specified. Proper read time is critical for optimal results.
Obtain results by direct colour chart comparison.

Note:

Όλες οι περιοχές αντιδραστηρίων μπορεί να διαβάζονται μεταξύ 1-2 λεπτών για τη διαφοροποίηση ενός θετικού δείγματος από ένα αρνητικό δείγμα. Οι αλλαγές στο χρώμα μετά από 2 λεπτά δεν έχουν διαγνωστική αξία.

Storage

Store at room temperature avoiding humidity and heat. Replace always cap immediately and tightly.

Quality Control

For best results, performance of reagent strips should be confirmed by comparing with known negative and positive specimens or controls. This procedure is recommended after use of every 25 urine strips and for each change in urine strip containers and lot

Results

Τα αποτελέσματα λαμβάνονται με άμεση σύγκριση της κλίμακας που έχει τυπωθεί στην ετικέτα του δοχείου.

Please note

On principle , diagnosis or therapy should not be based on one test result alone but should be established in the context of all other medical findings.

Availability

50 strips per box.
IVD in vitro diagnostic medical device
EC REP Authorized representative in the European Community

[RICH_REVIEWS_FORM]