Description
Rapid immunochromatographic test for the qualitative and presumptive detection of Group A Streptococcus antigens using a swab. The test is an in vitro diagnostic device, and is used as an aid in the diagnosis of Group A Streptococcus infection in patients presenting symptoms. Screen Test Streptococcus is for self-diagnosis. Children under 18 years of age must be supervised or assisted by an adult when performing the test. The test procedure is not automated. Test results should not be used as the sole basis for diagnosis, but are recommended to be interpreted by a physician in the clinical context.

Instructions for use
- The test must be used at room temperature (15°C to 30°C). If the test has been stored in a cool place (below 15°C), leave it at room temperature for 30 minutes before use.
- Make sure the packaging is intact. Do not use the test if the package is visibly damaged.
- Do not open the aluminum foil packaging until you are ready to perform the test. Use the test within one hour of opening.
- Note: Samples must be analyzed immediately after collection. Follow local regulations for the disposal of used tests.
TEST PROCEDURE
1. Wash hands with soap and water or use hand sanitizer for 20 seconds.
2. Add 4 drops of reagent 1 to the provided tube.
3. Add 4 drops of reagent 2 to the tube. Mix the solution by gently shaking the tube.
4. Insert the tube into the tube holder on the front of the package or the tube rack.
5. Open the swab package by pulling the free ends of the package. Remove the swab by the shaft. Do not touch the tip of the swab.
6. Hold the tongue down with a tongue depressor.
7. Insert the swab into the tube.
8. Rotate the swab by squeezing the bottom of the tube 10-15 times to apply gentle pressure to the tip of the swab.
9. Remove the swab. Squeeze the tube to extract as much liquid as possible from the swab.
10. Re-insert the nozzle into the extraction tube.
11. Invert the tube and add 3 drops of solution to the sample well, gently squeezing the tube.
12. Read the result after 5 minutes. After more than 10 minutes, the result is no longer valid.

Reading results
Positive: Two colored lines appear on the membrane. One line appears in the control area (C) and another in the test area (T).
Negative: Only one colored line appears in the control area (C). No line appears in the control area.
Invalid: The control band does not appear. The results of any test that did not produce a control band at the specified reading time must be discarded. Review the procedure and repeat the analysis with a new test. If the problem persists, stop using the kit immediately and contact the distributor.

Warnings
1. For in vitro diagnostic use only.
2. Before use, read the instructions for use. The instructions for use must be read carefully and followed.
3. Do not test or use components after the expiration date.
4. Do not use if the casing is damaged or opened.
5. Do not use the extraction buffer if it becomes discolored or cloudy. Discoloration or cloudiness may indicate microbial contamination.
6. Avoid cross-contamination of samples by using a new extraction tube for each sample obtained.
7. Do not mix or interchange reagents from different lots. Do not interchange solution bottle caps.
8. Avoid contact of eyes, skin, and mucous membranes with the swab. In case of contact with the swab, rinse thoroughly with water.
9. Keep out of reach of children.
10. Use only the provided test components.
11. Keep the swab clean. Do not touch the tip of the swab and ensure it does not touch any surface before use. Place the swab in the buffer immediately after sample collection.
12. This is a single-use test. Do not reuse tests.
13. This test is for human use only.
14. Dispose of kit components and used swab samples in household waste.
15. Since the test device contains a toxic composition and the highest morbidity rate of upper respiratory tract infection has been found in children, for children under 18 years of age, the test must be performed by parents or other adult family members.

Limitations
1. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should be made by the physician only after evaluating all clinical and laboratory results.
2. Failure to comply with the TEST PROCEDURE and INTERPRETATION OF RESULTS may negatively affect and/or falsify the test result.
3. The test does not distinguish asymptomatic carriers of Group A Streptococcus from those with symptomatic infection.
4. Respiratory infections, including pharyngitis, can be caused by streptococci of serogroups other than group A and by other pathogens.
5. The accuracy of the test depends on the quality of the swab sample. False negatives can result from incorrect sample collection or storage.
6. A negative result may also be obtained from patients at the onset of the disease due to low antigen concentration.
7. The device has not been tested on children under 4 years of age.

Storage
1. Store at 2-30°C in the sealed pouch until the expiration date.
2. Keep away from sunlight, moisture, and heat.
3. Do not freeze.
4. Open the pouch preferably just before testing. Use the test kit within 1 hour of opening the pouch.
5. The contents of the kit are stable until the expiration dates indicated on the outer packaging and containers.
6. The swabs in the kit are stable until the expiration date indicated on the swab tube.

Format
Materials provided:
- 2 tests;
- reagent 1;
- reagent 2;
- sterile tongue depressor;
- waste bag;
- sterile swab;
- WorkStation;
- extraction tube with nozzle;
- leaflet.

Code. ICOV-802H