Description
Rapid test for the detection of group A streptococcus in throat infections.
Group A beta-hemolytic strep throat (also known as Streptococcus pyogenes) 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 that resolve on their own without antibiotic treatment, which would be futile. While Group A strep throat infections can sometimes resolve within a few days without treatment, doctors prescribe antibiotics to prevent related complications that can be serious, such as rheumatic fever or acute glomerulonephritis. The Group A Strep Test is a specific immunoassay for the detection of Group A Streptococcus bacteria in throat infections. It helps to quickly know if the sore throat is caused by Streptococcus A or by other germs (usually viruses) that do not require antibiotic treatment.

How to use
1. Place the contents of the box on a clean, dry, flat surface (e.g. table).
2. Wash your hands thoroughly. Use soap and warm water.
3. Place the extraction tube into a hole in the workstation.
Throat swab sample collection
4. Collect a throat sample using the swab and tongue depressor provided:
a. open the package containing the tongue depressor and place it nearby;
b. 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;
c. stand in front of a mirror, tilt your head back and open your mouth as wide as possible;
d. Using the tongue depressor with 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 painful red areas (uvula, soft palate) to collect a sample.
Of course, you could ask some people to help you with sample collection.
Running the test procedure
5. After collecting the throat sample, insert the absorbent cotton tip of the swab into the extraction tube located on the workstation.
6. First open the dropper bottle with the blue cap (unscrew only 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.
7. Then open the dropper bottle with the green cap (just screw on the green cap and leave the white cap on) containing the extraction solution 2, dispense 6 drops into the tube and close the bottle.
8. 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 in the tube to incubate for a minimum of 2 minutes and a maximum of 5 minutes.
9. At the end of the incubation time, remove the tube from the recess (with the swab and liquid extracts still inside the tube) and, using your thumb and forefinger, press the wall 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). Discard the swab in a suitable waste container and place the tube with the extract in a hole in the workstation.
10. 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.
11. Read the result immediately after the reaction time has elapsed.

Interpretation of the results
1. Positive result
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 throat sample and that you should consult a doctor.
2. Negative result
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 throat sample or was not concentrated enough to be detected.
3. Inconclusive result
If there is no visible red line near the blue end of the strip handle (control line), the test is invalid and must be repeated using a new test and a new throat sample.

Warnings
1. This test is intended for in vitro diagnostic use. For external use only. Do not ingest.
2. 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.
3. Do not use after the expiration date printed on the label and protective pouch or if this pouch is damaged.
4. Do not reuse the STREPTOCOCCUS A TEST.
5. Keep out of reach of children.
6. After use, all components can be thrown into a garbage bin.
7. Not suitable for children under 2 years.
8. If liquids come into contact with eyes, skin or other mucous membranes, rinse immediately with plenty of water and contact a doctor.
9. 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