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.
When the specimen is added to the specimen well, capillary action causes the specimen to migrate across the membrane. When Strep A antigen levels in the specimen are at or above the cutoff, a visible colored line appears in the test region, indicating a positive result. The absence of this colored line in the test region suggests a negative result. If the test was performed correctly, a colored line will appear in the control region as a procedural control.
For in vitro self-diagnostic use only.

How to use
Sample collection and preparation
Collect the sample with the sterile throat swab provided in the kit. 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.
The test should ideally be performed immediately after sample collection.

Running the test
Bring the device and extraction reagents to room temperature (10-30°C) before performing the test.
Add 4 drops of Extraction Reagent A and 4 drops of Reagent B to the respective extraction tube and mix thoroughly.
Place the extraction swab in the test tube. Shake the swab ten times. Leave the swab in the test tube for 1 minute. Then remove the swab while pressing the swab head against the sides of the tube to release as much liquid as possible into the tube. Discard the used swab.
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 extracted sample to the sample well on the test cassette.
Wait 10 minutes and read the results. Do not read the results after 15 minutes.

Interpretation of the results
POSITIVE: Two colored lines appear, one in the test region (T) and one in the control region (C). You may have a Group A Streptococcus infection; consult your doctor.

NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test region (T). The concentration of Group A Streptococcus antigen is at or below the detection limit of the test.

INVALID: No colored line appears, or only one colored line appears in the test region (T) and no colored line appears in the control region (C). Failure of the control region (C) to appear indicates an error during the test procedure or deterioration of the test reagent. Repeat the test using a new kit. If the test still gives an invalid result, contact your local distributor.

Warnings
For in vitro self-diagnostic use only.
Do not ingest.
Do not interchange caps between reagents.
Do not use the test beyond the expiration date.
Keep out of reach of children.
Do not use the test if the package is punctured or not properly sealed.
The test is single use: discard after use.
Avoid contact of reagents A and B with eyes, sensitive mucous membranes, cuts, abrasions, etc. If reagents come into contact with skin or eyes, rinse thoroughly with water.
Do not eat, drink, or smoke in the area where specimens are handled and the test is performed.
The device used, the swab, and the extraction tube must be treated as contagious waste and therefore disposed of in biohazard waste containers.

Conservation
Store at 4-30°C. Keep away from sunlight, moisture, and heat. Do not freeze.
Shelf life in intact packaging: 24 months.

Format
The kit contains:
- 1 sealed sachet (containing a test device and a desiccant sachet);
- 1 extraction tube;
- 1 sterile throat swab;
- extraction reagents A and B;
- package leaflet.

Cod. W039P0001