Description
A lateral flow immunoassay for the qualitative detection of Group A Streptococcal antigen from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.
For in vitro self-diagnostic use only.
When specimen is added to the specimen well, capillary action causes the specimen to migrate across the membrane. When group A streptococcal antigen levels in specimens are at or above the cutoff, a visible colored line appears in the test region (T), indicating a positive result. The absence of this colored line in the test region (T) suggests a negative result. If the test was performed correctly, a colored line will appear in the control region (C) as a procedural control.

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

How to 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, pressing the swab head 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 test tube and mix the contents by shaking gently.
The sample must be tested immediately.
4. Remove the test from the sealed foil pouch by tearing at the notch and placing the test on a clean, dry, flat surface. Add 3 drops of mixed liquid sample from the tube to the sample well (represented by 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) and control (C) regions, the result is positive. This indicates that you may be experiencing a stage A Strep infection and should consult your doctor.
Negative
If only one colored line appears in the control region (C) and no colored line appears in the test region (T), the result is negative.
Indicates that the concentration of group A streptococcal antigen is at or below the limit of detection of the test.
Invalid
No visible line or only one visible line in the test region but not in the control region. This indicates a procedural error and/or deterioration of the test reagent.
Repeat the test with a new kit. If the test is still 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-diagnostic use only.
Do not ingest.
2. Do not interchange caps between reagents.
3. Do not use the test beyond the expiration date.
4. Keep out of reach of children.
5. Do not use the test if the pouch is punctured or not properly sealed.
6. Discard 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 the samples are and where the test will be performed.
9. Protective gloves should be worn when handling the sample. Wash your hands thoroughly after the procedure.
10. The device used, the swab and the extraction tube must be treated as contagious waste and therefore disposed of in biohazard containers.

Limitations
1. The results of this test should not be used to determine pharyngitis infections, since pharyngitis can be caused by organisms other than group A streptococcus. This test does not provide any information about pharyngitis other than that caused by group A streptococcal infection.
2. A negative result may occur due to an insufficient amount of specimen collected, or the addition of insufficient reagent A and B. If symptoms persist or worsen, always consult your doctor.
3. Excess blood or mucus in the collected sample may interfere with the performance of the test and could lead to a false-positive result. Do not touch your 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 only by a physician after evaluating all clinical and laboratory findings.
5. Since the test kit contains a toxic composition 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.

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

Format
Content
1. 2 individually sealed sachets, each containing:
- testing 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 throat swabs. The swab is used to collect the sample.
4. Extraction reagents A and B (Caution: Reagent B is toxic if swallowed).
5. Package leaflet with instructions for use.

Cod. W39-CH