One step strep a swab test - streptococcus a rapid test

Product Description

Rapid test for the detection of Streptococcus bacteria.

Indications

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 Group A Streptococcal antigen levels in the specimen are at or above the cut-off, 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.

Directions for Use

Specimen Collection and Preparation

Collect the specimen using 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 specimen extraction swab into the tube. Swirl the swab in the solution ten times. Leave the swab in the tube for one minute. Then remove the swab while pressing the swab head against the walls of the tube to extract as much liquid from the swab as possible. Discard the swab. Close the tube and mix the contents by gently swirling the tube. Remove the test from the sealed foil pouch and place the test on a clean, flat, dry surface. Add 3 drops of the mixed sample to the sample well of 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 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 region (T) and no colored line appears in the control region (C). Failure to appear of the control line (C) indicates an error during the testing procedure or deterioration of the test reagent. Repeat the test with a new kit. If the test still gives an invalid result, contact your local distributor.

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 package is perforated 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 samples are handled and where the test is performed. Wear protective gloves when handling the sample. Wash your hands thoroughly after the procedure. The used device, the swab, and the extraction tube must be treated as infectious waste and therefore disposed of in biohazard waste containers.

Storage

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

Format

The kit contains:

• 2 sealed pouches (each containing a test device and a desiccant sachet);
• 2 extraction tubes;
• 2 sterile throat swabs;
• Extraction reagents A and B;
• Package insert.