One step strep a swab test - rapid test for streptococcus a

Product Description

Rapid Strep A Swab Test.

Indications

One Step Strep A Swab Test by Screen Pharma is a lateral flow immunoassay for the qualitative detection of Group A Strep antigen from throat swab specimens to aid in the early diagnosis of Group A Strep infection.

Directions for use

Specimen 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 throat, tonsils, and other inflamed areas. Avoid touching the tongue, cheeks, and teeth with the swab. The test should ideally be performed immediately after specimen 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. Discard the used swab. Remove the test from the sealed foil pouch by tearing the notch and placing the test on a clean, dry, flat surface. Add 3 drops of the 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 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 to appear of the control line (C) indicates that an error occurred during the test procedure or that the test reagent has deteriorated. R

Warnings

For in vitro self-testing use only. Do not ingest. Do not interchange reagent caps. Do not use the test beyond the expiration date. Keep out of reach of children. Do not use the test if the pouch is punctured or not properly sealed. The test is for single use only: 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 specimens are handled and the test is performed. The used device, swab, and extraction tube must be treated as infectious waste and therefore disposed of in biohazard containers.

Storage

Store at 4-30°C. Keep away from sunlight, moisture, and heat. Do not freeze. Shelf life with 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.