Description
Immunological side scrolling test for qualitative detection of group A antigen from pharyngeal swab samples to help in early diagnosis of group A Streptococcus infection.
When the sample is added to the specific cockpit, the capillary action causes the sample to migrate through the membrane. When the levels of antigen of Streptococco A in the samples are equal or supeirori to the cut-off, a colored line visible in the test zone, which indicates a positive result. The absence of such colored line in the test zone suggests a negative result. If the test was correctly performed a colored line will appear on the control area as a procedural control method.
For self-diagnostic use in vitro.

Mode of use
Collection and preparation of samples
Collect the sample with the sterile pharyngeal pad provided in the kit. Keep your tongue down with a lower tongue. Tampon the back of the pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the tampon.
The test should be performed ideally immediately after the sample collection.

Test execution
Bring the device and extraction reagents to ambient temperature (10-30 °C) before running the test.
Add 4 drops of the extraction agent A and 4 drops of reagent B in the respective extraction test and mix completely.
Place the extraction pad in the tube. Shake the tampon ten times. Leave the pad in the tube for 1 minute. Then remove the swab while crushing the swab head against the walls of the tube in order to release as much liquid as possible within the tube. Throw the used tampon.
Remove the test from the sealed aluminum sachet, tearing where the notch is and place the test on a clean, dry and flat surface.
Add 3 drops of sample extracted into the sample well on the test box.
Wait 10 minutes and read the results. Do not read the results after 15 minutes.

Interpretation of results
POSITIVE: Two colored lines appear, one in the test zone (T) and one in the control area (C). A group A Streptococcus infection may be in place, it is recommended to consult your doctor.

NEGATIVE: only a coloured line appears in the control area (C). No coloured line appears in the test zone (T). The group A antigen concentration is equal to or below the test detection limit.

INVALIDO: no coloured line appears or only a coloured line appears in the test zone (T) and no coloured line appears in the control area (C). The failure of the control line (C) indicates that an error occurred during the test procedure or that a deterioration of the test reagent occurred. Repeat the test again with a new kit. If the test is to give an invalid result again, please contact the local distributor.

Warnings
Exclusively for self-diagnostic use in vitro.
Don't swallow.
Don't trade the plugs between the reagents.
Do not use the test beyond the expiry date.
Keep out of reach of children.
Do not use the test if the packaging is perforated or not well sealed.
The test is disposable: throw after use.
Avoid contact of A and B reagents with eyes, sensitive mucosa, membranes, cuts, abrasions, etc. If reagents come into contact with the skin or eyes, rinse thoroughly with water.
Do not eat drinking or smoking in the area where the samples are handled and where the test takes place.
The device used, the buffer and the extraction test must be treated as contagious waste and therefore thrown into containers for biologically hazardous waste.

Conservation
Store at 4-30 °C. Keep away from sunlight, moisture and heat. Don't freeze.
Validity of whole packaging: 24 months.

Format
The kit contains:
- 1 sealed envelope (containing a test device and a drying bag);
- 1 extraction test;
- 1 sterile pharyngeal swab;
- extraction reagents A and B;
- leaflet.

Cod. W039P0001