Strep A Antigen Home Test Qualitative Determination of Streptococcus A Antigens from Throat Swab 1 Piece Screen Italia

Description
An immunological lateral flow test for the qualitative detection of Group A Streptococcus antigen from throat swab samples to aid in the early diagnosis of Group A Streptococcus infection.
When the sample is added to the sample well, capillary action causes the sample to migrate across the membrane. When Group A Streptococcus antigen levels in the samples are equal to or greater than the cut-off, a visible colored line appears in the test region, indicating a positive result. The absence of such a colored line in the test region suggests a negative result. If the test has been performed correctly, a colored line will appear in the control region as a procedural control.
For in vitro self-diagnosis.

Instructions for use
Sample collection and preparation
Collect the sample with the sterile throat 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.

Test procedure
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 into the tube. Shake 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. Dispose of 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 the extracted sample into the sample well on the test cassette.
Wait 10 minutes and read the results. Do not read the results after 15 minutes.

Interpretation of results
POSITIVE: Two colored lines appear, one in the test region (T) and one in the control region (C). A Group A Streptococcus infection may be present; it is recommended to 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 equal to 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). 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 again yields an invalid result, contact your local distributor.

Warnings
For in vitro self-diagnostic use only.
Do not swallow.
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: dispose of after use.
Avoid contact of reagents A and B with eyes, sensitive mucous membranes, 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 contagious 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 of intact packaging: 24 months.

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

Code. W039P0001