How STREPA’LERT® strip test does work?
In case of sore throat infections, the Group A β-hemolytic streptococcus bacteria may be involved. In order to cure it using antibiotic treatment, it is first necessary to identify it. Thanks to a specific extraction process for throat swab samples, a Group A streptococcus marker (LPS antigen) can be isolated and further identified using specific anti LPS antigen antibodies.
When should the test be used?
The STREPA’LERT® test should be performed in case of strep throat symptoms such as red / swollen throat or tonsils, body aches, headaches, nausea, vomiting or listlessness.
Group A β-hemolytic streptococcus (also known as Streptococcus pyogenes) infection of the throat is the most common bacterial cause of acute pharyngitis and is also responsible for some skin infections such as impetigo and erysipelas. Most sore throats are caused by viral infections which clear up on their own without antibiotic treatment, which would be useless. While Strep A throat infections sometimes can
go away within a few days without treatment, physicians prescribe antibiotics to prevent related complications that can be serious, such as rheumatic fever or acute glomerulonephritis. The Streptococcus test is a specific immunological test for
the detection of group A streptococcus bacteria in throat infection. It helps to quickly know whether a sore throat is caused by a Strep A or other germs (usually viruses) that do not require antibiotic treatment.
The box contains the material needed to perform a test:
– 1 sealed aluminium pouch containing:
1 strip test and 1 desiccant pouch.
Only open the protective pouch when you are ready to use the
test. The desiccant pouch should be discarded.
– 1 sterile swab
– 1 sterile wooden tongue depressor
– 1 bottle of extraction solution 1 (blue cap): 1mL
– 1 bottle of extraction solution 2 (green cap): 1mL
– 1 empty extraction tube
– 1 foam workstation
– 1 instruction leaflet
- This test is intended to in vitro diagnostic use. External use
only. DO NOT SWALLOW.
- Carefully read the instructions before performing the test.
The test is only interpretable if the instructions are carefully
respected. Strictly follow the indicated reaction time, swab
sample collection and extraction steps.
- Store between +4°C and +30°C. Do not freeze.
- Do not use after the expiry date printed on the label and on the
protective pouch or if this pouch is damaged.
- Do not reuse the Streptococcus test.
- Keep out of reach of children.
- After use, all the components can be discarded in a dustbin.
- Not suitable for children under 2 years’ old.
- If the liquids come in contact with the eyes, skin or other
mucous membranes, rinse immediately and thoroughly with
water and contact a physician.
- Do not ingest the liquid extract and other parts of the box! If
they are ingested, immediately seek for medical advice and bring
the remaining parts of the box with you along with the
instructions for use and the packaging.
-Testing procedure always starts with a good preparation.
- Place the content of the box on a clean, dry and flat surface
(e.g. table). Then proceed as follows:
- Wash your hands thoroughly. Use soap and warm water.
- Place the extraction tube into one notch of the foam work
-Collecting the throat swab sample
- Collect a throat sample using the supplied swab and tongue
a/ Open the package containing the tongue depressor and place it
next to you.
b/ Open the package containing the swab and remove it by seizing
the plastic handle. Avoid touching the absorbent cotton tip of the
swab with your hands
c/ Place yourself in front of a mirror, tilt your head back and open
your mouth as wide as possiblee.
d/ Using the tongue depressor with one hand, press down your
tongue and with the other hand brush the soft cotton swab over the
back throat, around the tonsils and over any red or sore areas (uvula,
soft palate) to collect a samplef. Of course, you may request some people to help you for the sample collection.
– Running the test procedure
After collecting the throat sample, insert the absorbent cotton tip of
the swab into the extraction tube placed on the foam workstation
- Open the blue cap dropper bottle first (only unscrew the blue cap
and leave the white cap tightly closed) containing the extraction
solution 1, dispense 6 drops into the tube and close the bottle. 6
- Then open the green cap dropper bottle (only unscrew the green
cap and leave the white cap tightly closed) containing the extraction
solution 2, dispense 6 drops into the tube and close the bottle
- Hold the swab by the plastic handle and twirl it thoroughly against the wall of the tube (around 10 times) to mix the solution. Leave the swab inside the tube for incubation for 2 minutes as the minimum and 5 minutes as the
- At the end of the incubation time, remove the tube from the notch (with the swab and the liquid extracts still inside the tube) and, using your thumb and your forefinger press the tube’s wall to squeeze the cotton tip of the swab in order to collect as much liquid as possible (proceed that way while removing the swab from the tube). Discard the swab in an appropriate waste container and replace the tube with the extract in one notch of the workstation.
- Open the protective aluminium pouch, hold the strip by the blue end and place it into the tube containing the extracts. Leave it inside the tube for 5 to 10 minutes in order for the reaction to occur.l
- Read the result after 5 to 10 minutes. Do not interpret after 10 minutes.
1/ Positive result:
Two (2) red / purple coloured lines appear on the strip. The
colour intensity of the lines may be different. This result is
positive and means that Strep A was found in the throat sample
and that you should consult a physician
2/ Negative result:
Only one (1) red line (control line) appears close to the blue end
of the strip. This result is negative and it means that Strep A was
not found in the throat sample or was not concentrated enough to
3/ Inconclusive result:
If there is no visible red line close to the blue handle end of the
strip (control line), the test is not valid and should be repeated
using a new test and a new throat sample.
QUESTIONS AND ANSWERS
Can the result be incorrect?
The results are accurate as far as the instructions are
carefully respected. Nevertheless, the result can be incorrect if
STREPTOCOCCUStest gets wet before test performing or if the
throat sample is not correctly collected and prepared.
How to interpret the test if the colour intensity of the lines is
The colour intensity of the lines is not important to interpret the
test result. The lines should only be homogeneous and clearly
visible. The test should be considered as positive whatever the
colour intensity of the test line, even weak.
What is the purpose of the control line appearing close to the
blue end of the strip?
When this line appears, it only means that the test performed
If I read the result after 10 minutes, will the result be reliable?
The result should be read within 5 to 10 minutes. The result is
reliable up to 10 minutes.
What should I do if the result is positive?
A positive result means that the Group A strep was present in the
throat sample and that you should consult a physician. Then the
physician will decide about next step.
What should I do if the result is negative?
A negative result means that either the sore throat was viral or
that the sample was not containing enough Strep A bacteria for
detection. If the symptoms persist, it is recommended to consult