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.
When the sample is added to the well, capillary action causes the sample to migrate across the membrane. When Group A Strep antigen levels in the samples are at or above the cut-off, a visible colored line appears in the test area, indicating a positive result. The absence of such a colored line in the test area suggests a negative result. If the test has been performed correctly, a colored line will appear in the control area as a procedural control method.
For in vitro self-diagnostic use.

Instructions for use
Sample collection and preparation
Collect the sample with the sterile pharyngeal swab provided in the kit. Hold down the tongue 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.
The test should ideally be performed immediately after sample collection.

Performing 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 tube. Swirl the swab ten times. Leave the swab in the tube for 1 minute. Then remove the swab while pressing the swab head against the walls 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, 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 results after 15 minutes.

Interpretation of results
POSITIVE: Two colored lines appear, one in the test area (T) and one in the control area (C). A Group A Strep infection may be present; it is recommended to consult your doctor.

NEGATIVE: Only one colored line appears in the control area (C). No colored line appears in the test area (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 area (T) and no colored line appears in the control area (C). The absence of the control line (C) indicates that an error occurred during the test procedure or that the test reagent has deteriorated. Repeat the test again with a new kit. If the test yields an invalid result again, contact the local distributor.

Warnings
For in vitro self-diagnostic use only.
Do not ingest.
Do not swap 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 well 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 samples are handled and where the test is performed.
The used device, swab, and extraction tube should be treated as infectious waste and therefore disposed of in biohazard waste containers.

Storage
Store at 4-30 °C. Keep away from sunlight, humidity, and heat. Do not freeze.
Shelf life unopened: 24 months.

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

Code W039P0001