RAPID SELF-DIAGNOSTIC TEST FOR STREPTOCOCCUS AT SOFARMAPIU'

Description
Specific immunological test for the detection of Group A Streptococcus bacteria in throat infections. It helps quickly determine whether the sore throat is caused by Group A Streptococcus or other germs (usually viruses) that do not require antibiotic treatment.

How to use
Place the contents of the box on a clean, dry, flat surface (e.g. table).
Wash your hands thoroughly. Use soap and warm water.
Place the extraction tube into a hole in the workstation.

Sample collection
Collect a throat sample using the swab and tongue depressor provided. Open the package containing the tongue depressor and place it nearby. Open the package containing the swab and remove it by grasping the plastic handle.
Avoid touching the absorbent cotton tip of the swab with your hands.
Stand in front of a mirror, tilt your head back, and open your mouth as wide as possible. Using the tongue depressor in one hand, depress your tongue, and with the other hand, brush the soft cotton ball over the back of your throat, around your tonsils, and any red, tender areas (uvula, soft palate) to collect the sample.
Of course, you can ask for help in collecting samples.

Running the test procedure
After collecting the throat sample, insert the absorbent cotton tip of the swab into the extraction tube located on the workstation.
First open the dropper bottle with the blue cap (unscrew only the blue cap and leave the white cap tightly closed) containing extraction solution 1, dispense 6 drops into the tube, and close the bottle. Then open the dropper bottle with the green cap (screw only the green cap and leave the white cap tightly closed) containing extraction solution 2, dispense 6 drops into the tube, and close the bottle.
Hold the swab by the plastic handle and carefully rotate it against the wall of the tube (about 10 times) to mix the solution. Leave the swab inside the tube to incubate for a minimum of 2 minutes and a maximum of 5 minutes. At the end of the incubation time, remove the tube (with the swab and liquid extracts still inside) and, using your thumb and forefinger, press the walls of the tube to squeeze the cotton tip of the swab to collect as much liquid as possible (proceed in this manner while removing the swab from the tube). Dispose of the swab in a suitable waste container and place the tube with the extracted solution in a hole on the workstation.
Open the protective foil pouch, hold the strip by the blue end, and insert it into the tube containing the extracts. Leave it in the tube for 5 minutes (minimum) to 10 minutes (maximum) for the reaction to occur.
Read the result immediately after the reaction time has elapsed.

Interpretation of the results
POSITIVE: Two (2) red/purple lines appear on the strip. The color intensity of the lines may vary. This result is positive and means that Streptococcus A has been found in the sample and that you should consult a doctor.

NEGATIVE: Only one (1) red line (control line) appears near the blue end of the strip. This result is negative and means that Streptococcus A was not found in the specimen or was not present in sufficient concentration to be detected.

INVALID: If there is no visible red line near the blue end of the strip (control line), the test is invalid and must be repeated using a new test and a new sample.

Warnings
This test is intended for in vitro diagnostic use.
For external use only. Do not ingest.
Read the instructions carefully before performing the test. The test is interpretable only if the instructions are strictly followed. Strictly follow the indicated reaction time, swab sample collection, and extraction steps.
Do not use after the expiration date printed on the label and protective pouch or if this pouch is damaged.
Do not reuse the STREPTOCOCCUS A TEST.
Keep out of reach of children.
After use, all components can be thrown into a garbage bin.
Not suitable for children under 2 years.
If liquid comes into contact with eyes, skin, or other mucous membranes, rinse immediately with plenty of water and contact a doctor.
Do not ingest the liquid extract or any other parts of the box. If swallowed, seek medical advice immediately and take the remaining parts of the box with you, along with the instructions for use and packaging.

Conservation
Store between 4°C and 30°C. Do not freeze.

Format
- 1 sealed aluminum pouch containing: 1 test strip and 1 desiccant sachet.
- 1 sterile swab.
- 1 sterile wooden tongue depressor.
- 1 dropper bottle of extraction solution 1 (blue cap): 1 ml.
- 1 dropper bottle of extraction solution 2 (green cap): 1 ml.
- 1 empty extraction tube.
- 1 workstation.
- 1 instruction sheet.

Cod. SF013