Exacto Urinary infection Test

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PRECAUTIONS

 

Please read the directions for use carefully before performing the test.
• Intended for self-diagnosis.
• Urine test only; not to be used as a blood test.
• Do not use the test beyond the expiry date.
• Keep out of reach of children.
• For in vitro diagnostic use only; not for internal use.
• Once used, the test should be discarded according to local regulations. Allow the strip and urine sample to return to room temperature (15-30°C) before use. Use first-morning urine after your first urination. Wash your genital area with soap gently but thoroughly and rinse well before performing
the test. 

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READING TIME

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Reagents

 

Leukocytes (LEU) 2 minutes

Blood (BLO) 1 minute
Nitrite (NIT) 1 minute
Proteins (PRO) 1 minute

 

INTERPRETATION
Please refer to the colour scale.
1. Remove the strip from the aluminium pouch just before
use. Do not touch the reagent areas.
2. Let your urine flow for 1-2 seconds, then hold the strip in a
way so as to place the reagent zones under the urine stream
for 1 to 2 seconds. Ensure that all reagent zones have been
well soaked in urine.
N.B.: if you prefer, you can urinate in a clean and dry container.
In such cases, dip the strip’s reagent zones in the urine
and immediately remove the strip from the urine to avoid
dissolving the reagents. When removing the strip from the
urine, slide the edge of the strip against the edges of the
urine container to remove any excess urine.
3. Hold the strip horizontally and place it on an absorbent
fabric (e.g. a paper towel) to avoid mixing the chemicals of
adjacent reagent zones and/or getting urine on your hands.
4. Compare the reagent zones with the relevant colour blocks
on the colour scale. Hold the strip close to the colour blocks
and compare carefully.

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STORAGE AND HANDLING
• Store in a dry place at a temperature between 2°C and 30°C.
• Do not freeze and do not expose to direct sunlight.
• Keep the strips in their packaging until you use them.
• Exposing the strips to air for a long time could destroy the reagents, leading to erroneous
results.
• Do not use a strip if its packaging is ripped or damaged.
• Do not touch the reagent areas on the strip.

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PRINCIPLES AND LIMITS

LEUKOCYTES: A leukocyte (or white blood cell) count is based on the detection of specific enzymes of
these cells. These cells are present in urine in the event of inflammation caused by an infection. The colour
of the reagent zone ranges from pink to purple, if there is an infection. A high protein concentration (> 500
mg/dL), a high glucose concentration (> 2 g/dL) or a high antibody concentration may give false results.
NITRITES: Nitrites are produced by the bacteria responsible for most urinary infections (enterobacteria). If
you have a urinary infection caused by such bacteria, the reagent zone will turn pink. Fasting, a vegetablefree
diet or taking medicinal products containing phenazopyridine may lead to false results.

PROTEINS: Proteins found in urine can give false positive results for the LEUKOCYTES parameter. If there are proteins in your urine, the reagent zone will change colour from yellow to green or even blue.

BLOOD: If there is blood in your urine, the relevant reagent zone will range from orange to green or even
dark blue. Blood in urine is a potential sign of a severe condition. If the result is positive, consult your doctor.
Tests performed on women who are on their period often give positive results.

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PERFORMANCE AND CHARACTERISTICS

 

The performance of urinalysis reagent strips has been determined by both laboratory and
clinical tests. The interpretation of visual results depends on several factors: the variability
of colour perception, inhibiting factors or lack thereof, and light conditions when reading
the test.

Accuracy:
Samples were tested using the EXACTO® Urinary Infection Test. The same samples were
tested using a different product available on the market (Bayer Multistix 10 SG Reagent
Strips for Urinalysis) for comparison purposes.

 

EXACTO® Urinary Infection Test vs. Other reading system

 

RESULTS (Exacto/Bayer) 95% confidence interval

Parameter

Leukocytes 122/125 97.6% (93% - 99%)

Nitrites 125/125 100% (97% - 100%)

Proteins 110/125 88% (81% - 93%)

Blood 120/125 96% (91% - 99%)

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Usability:
A usability test was performed by comparing readings by patients with those by trained
professionals.
Reading of the Reading of the EXACTO® Urinary Infection Test strips Patients vs. Professionals

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RESULTS (Patient/Professional) 95% confidence interval

Parameter

Leukocytes 100/100 100% (96% - 100%)
Nitrites 100/100 100% (96% - 100%)
Proteins 100/100 100% (96% - 100%)
Blood 100/100 100% (96% - 100%)

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Detection limits:

LIMIT OF DETECTION IN URINE

Parameter

Leukocytes 9 leukocytes/μL
Nitrites 0.05 mg/dL (using ascorbic acid < 30 mg/dL)
Proteins For albumin: 0.075 g/L
Blood Free haemoglobin: 0.018 mg/dL or 5 RBC/μL
(using ascorbic acid < 50 mg/dL)

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BIBLIOGRAPHY
1. Tietz NW. Clinical Guide to Laboratory Tests. W.B. Saunders Company. 1976.
2. Burtis CA, Ashwood ER. Tietz Textbook of Clinical Chemistry 2nd Ed. 2205, 1994.