Gensure strep a - rapid throat swab test

Product Description

The Gensure Strep A Rapid Self-Test is a lateral flow immunoassay for the rapid, qualitative detection of Streptococcus pyogenes antigen in throat swab specimens.

Indications

The Strep A Rapid Test is a lateral flow immunoassay for the rapid, qualitative detection of Streptococcus pyogenes (group A streptococcus, Gas) antigen in throat swab specimens collected from individuals with suspected Strep A infection.

The test is This product is intended to aid in the diagnosis of Group A Streptococcus infection and should not be used as the sole criterion for clinical decision-making.

This is a non-automated in vitro diagnostic medical device intended for professional laboratory use and for home self-testing.

For children and adolescents under 15 years of age, sample collection and testing must be performed by a responsible adult.

How to use Instructions for Use and Dosage

• Wash your hands thoroughly.
• Before performing the test, check that all kit components are present and intact.
• Check the expiration date indicated on the sealed pouch.
• Do not use the test if it has expired.
• Remove the cap from the tube containing the extraction buffer and insert the tube into the appropriate slot in the package.
• Open the disposable swab package. Hold the swab by the plastic shaft. Do not touch the tip of the swab.
• Preferably in front of a mirror, tilt your head back and open your mouth as wide as possible. If available, use a tongue depressor to depress the tongue.
• Gently rub the tip of the swab on the back of the throat, around the tonsils, and on any red or painful areas (soft palate, uvula).
• Rotate the swab several times to increase the amount of sample collected.
• Ask others to help you collect the sample if you feel resistance.
• If you are swabbing others, wear a mask.
• It is recommended that swab samples collected be tested immediately after collection.
• For professionals, if the sample cannot be processed immediately, it should be stored immediately in a clean, tightly sealed plastic tube.
• It can be stored: at room temperature (15–25°C) for 8 hours; at 2–8°C for 72 hours; at -20°C for 6 months.
• The specimen can be frozen and thawed at -20°C a total of two times.
• The throat swab is extracted into a storage buffer, and the extract can be stored at room temperature for 8 hours.
• Insert the swab into the tube containing the extraction buffer.
• Dive the swab up and down in the liquid at least 10 times, avoiding spills.
• Leave the swab in the tube for 1 minute.
• Remove the swab by pressing it against the wall of the tube to extract as much of the sample as possible. liquid possible.
• Dispose of the swab according to local regulations.
• Firmly attach the dropper to the tube.
• Remove the test cassette from the sealed pouch and use it within 1 hour of opening, at a temperature between 5°C and 35°C and a relative humidity of 20–80%.
• If the kit is If the test cassette has been stored at low temperatures, allow it to reach room temperature for at least 30 minutes before use.
• Slowly add 3 drops of the sample to the sample well (S) of the test cassette.
• Start the timer.
• Avoid air bubbles and do not add sample to the reading window.
• Read the result 5-10 minutes after adding the sample; do not evaluate the result after 10 minutes.
• After completing the test, dispose of all used components in household or medical waste according to local regulations. Wash your hands thoroughly.

Positive
Two colored lines appear: one line in the control region (C) and one line in the test region (T).
The intensity of the T line may vary. be lower than the C line.

Negative
Only one colored line appears in the control region (C).
No line appears in the test region (T).

Invalid
The control line does not appear.
Insufficient specimen volume or incorrect procedural techniques are the most likely causes of control line failure.
Review the procedure and repeat the test using a new test cartridge. If the problem persists, discontinue use of the lot immediately and contact your local distributor.

Warnings

Read these instructions for use carefully before performing the test. The test provides reliable results only if all instructions are followed correctly, including proper specimen collection, extraction procedure, and reading time.

Do not use the kit contents beyond the expiration date indicated on the outer packaging.

Each test is for single use only. Do not reuse kit components.

Do not open sealed components (test cassette, swabs) until ready to use. Open only as directed.

Improper specimen collection, storage, or transportation may result in unreliable results.

Use only the swab provided in the kit. Using alternative swabs may cause errors. This may cause false-negative results.

After opening the sealed pouch, the test cassette must be used within 60 minutes at a temperature between 5°C and 35°C and a relative humidity of 20–80%.

Keep the kit and its components out of the reach of children and pets before and after use. Avoid ingestion of the extraction buffer. If swallowed, seek medical advice immediately.

If the extraction buffer comes into contact with skin, eyes, nose, or mouth, rinse immediately with plenty of water. If irritation persists, consult a doctor.

In children, sample collection and testing must be performed by an adult.

To reduce the risk of spreading infection, dispose of all used kit components in household or medical waste in accordance with local regulations.

When this test is used as a home test (self-test), it is for self-assessment only and cannot provide a definitive diagnosis. Do not change or discontinue any medical treatment based on the test results without consulting a doctor.

Storage

Store at 40°F to 86°F (4°C to 30°C), away from direct sunlight.

Shelf life: 12 months. In unopened packaging: 24 months.

Format

1 test.