Description
Lateral flow immunological test for the qualitative detection of group A streptococcus antigen from pharyngeal swab samples to assist in the early diagnosis of group A streptococcal infection.
For in vitro self-diagnostic use.
When the sample is added to the designated well, capillary action causes the sample to migrate across the membrane. When the levels of group A streptococcal antigen in the samples are equal to or above the cut-off, a visible colored line appears in the test area indicating a positive result. The absence of such a colored line in the Test (T) area suggests a negative result. If the test has been performed correctly, a colored line will appear in the control (C) area as a procedural control.

Sample Collection and Preparation
1. Collect the sample with the sterile pharyngeal swab provided in the kit.
2. Hold down the tongue with a tongue depressor. Swab the back of the throat, 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.

Usage Instructions
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.
Swirl 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 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 aluminum pouch by tearing where indicated and place the test on a clean, dry, flat surface. Add 3 drops of mixed liquid sample from the tube to the sample well (indicated by an arrow) of the test cassette by inverting and squeezing the tube.
5. Wait 10 minutes and read the results. Do not read results after 15 minutes.

Reading Results
Positive
If two colored lines are visible in both the test (T) area and the control (C) area, the result is positive. This indicates that you may be in the early stages of a group A streptococcal infection and should consult your doctor.
Negative
If a single colored line appears in the control (C) area and no colored line appears in the test (T) area, 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 visible line in the test area but not in the control area. This indicates a procedural error and/or that the test reagent has deteriorated.
Repeat the test with a new kit. If the test is still invalid, please contact the distributor or store where the product was purchased, providing the batch number.

Precautions
1. This kit is for in vitro self-diagnostic use only.
Do not ingest.
2. Do not swap caps between reagents.
3. Do not use the test after the expiration date.
4. Keep out of reach of children.
5. Do not use the test if the pouch is perforated or not well sealed.
6. Dispose of after use. The test is for single use only.
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 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 biohazard waste and 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 streptococcal infection.
2. A negative result may occur due to an insufficient amount of sample collected, or insufficient addition of reagents A and B. If symptoms persist or worsen, always consult your doctor.
3. Excess blood or mucus in the collected sample may interfere with test performance and may 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 physician after evaluating all clinical and laboratory results.
5. Since the test kit contains a toxic composition and the highest morbidity rate from upper respiratory 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 expiration date.
Keep away from sunlight, humidity, and heat. Do not freeze.
Preferably open the pouch just before performing the test.

Format
Contents
1. 2 individually sealed pouches, each containing:
– test device;
– desiccant pouch.
The desiccant is for preservation purposes only and is not used during the test 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. Instruction leaflet with usage instructions.