Description
Immunological lateral flow test for the qualitative detection of Group A Streptococcus antigen from pharyngeal swab samples to aid in the early diagnosis of Group A Streptococcus infection.
For in vitro self-diagnostic use.
When the sample is added to the designated well, capillary action causes the sample to migrate through the membrane. When Group A streptococcal antigen levels in the samples are equal to or greater than the cut-off, a visible colored line appears in the test zone, indicating a positive result. The absence of this colored line in the Test (T) zone suggests a negative result. If the test has been performed correctly, a colored line will appear in the control (C) zone as a procedural control.

Sample collection and preparation
1. Collect the sample with the sterile pharyngeal swab provided in the kit.
2. Hold the tongue down with a tongue depressor. Swab the back of the pharynx, tonsils, and other inflamed areas. Avoid touching the tongue, cheeks, and teeth with the swab.
3. The test should ideally be performed immediately after sample collection.

Instructions for use
Bring the device and extraction reagents to room temperature (10 °C-30 °C) before performing the test.
1. Add 4 drops of extraction reagent A and 4 drops of reagent B to the respective extraction tube and mix thoroughly.
2. Place the sample extraction swab into the tube.
Shake the swab ten times. Leave the swab in the tube for one minute. Then remove the swab while pressing the swab head against the inside of the tube as you remove it to eliminate as much liquid as possible from the swab. Discard the swab.
3. Cap the tube and mix the contents by gently shaking.
The sample must be tested immediately.
4. Remove the test from the sealed foil pouch by tearing at the notch and place the test on a clean, dry, flat surface. Add 3 drops of mixed liquid sample from the tube to the sample well (depicting an arrow) of the test cassette by inverting and squeezing the tube.
5. Wait 10 minutes and read the results. Do not read the results after 15 minutes.

Reading the results
Positive
If two colored lines are visible in both the test (T) zone and the control (C) area, the result is positive. This indicates that you may be in a Group A Strep infection phase and you should consult your doctor.
Negative
If only one colored line appears in the control zone (C) and no colored line appears in the test band (T), the result is negative.
This indicates that the concentration of Group A streptococcal antigen is equal to or below the detection limit of the test.
Invalid
No visible line or only one line visible in the test zone but not in the control zone. This is an indication of a procedural error and/or that test reagent deterioration has occurred.
Repeat the test with a new kit. If the test is still invalid, please contact the distributor or the store where the product was purchased, providing the lot number.

Precautions
1. This kit is for in vitro self-diagnostic use only.
Do not ingest.
2. Do not interchange caps between reagents.
3. Do not use the test beyond the expiry date.
4. Keep out of reach of children.
5. Do not use the test if the pouch is perforated or not well sealed.
6. Discard after use. The test is single-use.
7. Avoid contact of reagents A and B with eyes, sensitive mucous membranes, cuts, abrasions, etc. If these reagents come into contact with skin or eyes, rinse thoroughly with water.
8. Do not eat, drink or smoke in the area where samples are stored and where the test will be performed.
9. Protective gloves should be worn when handling the sample. Wash hands thoroughly after the procedure.
10. The used device, swab, and extraction tube should be treated as infectious waste and therefore disposed of in biohazard containers.

Limitations
1. The results of this test should not be used to determine pharyngitis infections, as pharyngitis can be caused by organisms other than Group A Streptococcus. This test does not provide any information on pharyngitis other than that caused by Group A Streptococcus infection.
2. A negative result may occur due to an insufficient amount of sample collected, or insufficient addition of reagent A and B. If symptoms persist or worsen, always consult your doctor.
3. Excess blood or mucus in the collected sample could interfere with test performance and could lead to a false positive result. Do not touch the tongue, cheeks, teeth, or any bleeding areas of the mouth with the swab during the sample collection phase.
4. As with any diagnostic procedure, a diagnosis should be confirmed exclusively by a doctor after evaluating all clinical and laboratory results.
5. Since a toxic composition is present in the test kit and the highest rate of morbidity from upper respiratory tract infections has been found in children, the test should be performed by parents or another adult family member on all minors under 16 years of age.

Storage
Store at 4 °C-30 °C in the sealed package until the expiry date.
Keep away from sunlight, humidity, and heat. Do not freeze.
Preferably open the pouch just before performing the test.

Format
Content
1. 2 individually sealed pouches, each containing:
- test device;
- desiccant sachet.
The desiccant is for storage purposes only; it is not used during the testing procedure.
2. 2 extraction tubes.
3. 2 sterile pharyngeal swabs. The swab is used to collect the sample.
4. Extraction reagents A and B (caution: reagent B is toxic if ingested).
5. Package leaflet with instructions for use.