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-testing.
When the sample is added to the well, capillary action causes the sample to migrate across the membrane. When Group A streptococcal antigen levels in the samples are equal to or greater than the cut-off, a visible coloured line appears in the test zone, indicating a positive result. The absence of such a coloured line in the Test (T) zone suggests a negative result. If the test has been performed correctly, a coloured 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 into 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 squeezing the head of the swab against the inside of the tube as you remove it to remove 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 results after 15 minutes.

Reading the results
Positive
If two coloured lines are visible in both the test zone (T) and the control area (C), the result is positive. This indicates that you may have a Group A Streptococcus infection and you should consult your doctor.
Negative
If only one coloured line appears in the control zone (C) and no coloured line appears in the test strip (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 line visible or only one line visible in the test zone but not in the control zone. This is an indication of procedural error and/or that the test reagent has deteriorated.
Repeat the test with a new kit. If the test still proves invalid, please contact the distributor or the store where you purchased the product, providing the batch number.

Precautions
1. This kit is for in vitro self-testing 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 punctured or not well sealed.
6. Discard after use. The test is for 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 located 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 provides no information on pharyngitis other than that caused by Group A streptococcal infection.
2. A negative result may occur due to insufficient 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 sample collection.
4. As with any diagnostic procedure, a diagnosis should be confirmed solely by a doctor after evaluating all clinical and laboratory results.
5. Since a toxic composition is present in the test kit and the highest morbidity rate 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, moisture 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 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.

Code. W039P0001