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

How to 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), let it stand at room temperature for 30 minutes before using.
- Make sure the packaging is intact. Do not use the test if the packaging is visibly damaged.
- Do not open the foil pouch 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 disposal of used tests.
TEST PROCEDURE
1. Wash your hands with soap and water or use hand sanitizer for 20 seconds.
2. Add 4 drops of reagent 1 to the tube provided.
3. Add 4 drops of reagent 2 to the test tube. Mix the solution by gently shaking the test tube.
4. Insert the test tube into the test tube holder on the front of the package or test tube holder.
5. Open the swab package by pulling the free ends of the package. Remove the swab from the stem. Do not touch the tip of the swab.
6. Hold the tongue still with a tongue depressor.
7. Insert the swab into the test tube.
8. Rotate the swab by squeezing the bottom of the tube 10-15 times to exert light pressure on the tip of the swab.
9. Remove the swab. Squeeze the tube to expel as much liquid as possible from the swab.
10. Insert the nozzle back 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 After more than 10 minutes, the result is no longer valid.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 the results
Positive: Two colored lines appear on the membrane. One line appears in the control region (C) and another in the test region (T).
Negative: Only one colored stripe appears in the control area (C). No stripe appears in the control area.
Invalid: The control line does not appear. Any test that does not produce a control line at the specified time should be discarded. Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the kit immediately and contact the distributor.

Warnings
1. For in vitro diagnostic use only.
2. Read the instructions for use before 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 case is damaged or open.
5. Do not use the extraction buffer if it becomes discolored or cloudy. Discoloration or turbidity 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 with eyes, skin, and mucous membranes with the swab. If the swab comes into contact with the skin, rinse thoroughly with water.
9. Keep out of reach of children.
10. Use only the test components provided.
11. Keep the swab clean. Do not touch the swab tip and ensure it does not touch any surface before use. Place the swab in the swab immediately after collecting the sample.
12. This is a single-use test. Do not reuse the 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 was found in children, for children under 18 years of age the test should be performed by parents or other adult family members.

Limitations
1. As with all diagnostic tests, the 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 findings.
2. Failure to follow the TEST PROCEDURE and INTERPRETATION OF RESULTS may negatively influence and/or distort 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 may result from improper sample collection or storage.
6. A negative result can also be obtained from patients at the onset of the disease due to the low antigen concentration.
7. The device has not been tested on children under 4 years of age.

Conservation
1. Store at 2-30°C in the sealed pouch until the expiry 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 expiry 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;
- package leaflet.

Cod. ICOV-802H