Description
Immunoassay lateral slide assay for the qualitative detection of Group A Streptococcus antigen from throat swab specimens to aid in the early diagnosis of Group A Streptococcus infection.
When you add the sample to the sample well, capillary action causes the sample to migrate across the membrane. When Streptococcal antigen levels in specimens are at or above 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 area suggests a negative result. If the test has been performed correctly a colored line will appear on the control zone as a method of procedural control.
For in vitro self-diagnostic use.

Instructions for 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 the pharynx, 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.

Test execution
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 squeezing the swab head against the walls of the tube in order to release as much liquid as possible into the tube. Throw away the used swab.
Remove the test from the sealed foil pouch, tearing where there is stain, 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 results
POSITIVE: two colored lines appear, one in the test area (T) and one in the control area (C). You may have a Group A Streptococcus infection, it is advisable to consult your doctor.

NEGATIVE: Only a colored line appears in the control area (C). No colored lines appear in the test zone (T). The Group A Streptococcus antigen concentration 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). If the control line (C) does not appear, an error occurred during the testing procedure or deterioration of the test reagent occurred. Repeat the test again with a new kit. If the test returns an invalid result, contact your local distributor.

Warnings
For in vitro self-testing use only.
Do not swallow.
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 well sealed.
The test is disposable: discard 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 the test is performed.
The arrangement