Sars-cov-2 antigen rapid test kit - nasal test

Product Description

SARS-CoV-2 detection test.

Indications

SARS-CoV-2 Antigen Rapid Test Kit from Egens is a rapid test for the detection of SARS-CoV-2 and to qualitatively detect the N antigen of the novel coronavirus in the human anterior nostril. The kit is suitable for adults over 18 years of age, minors under 18 years of age require sampling from guardians. The elderly and those who cannot operate independently should complete the test with professional guidance or assistance.

Directions for Use

Allow the test device, specimen, and sponge to equilibrate to room temperature (15-30°C) before testing and use as soon as possible.

1. Wash your hands before starting the test.
2. Inspect all components for possible damage and all provided materials for integrity. Place all provided materials on a clean, dry, and flat surface.
3. Pinch the top of the extraction tube and shake it several times to completely drop the swab to the bottom of the tube. Remove the aluminum foil seal from the extraction tube containing the buffer solution. (*Note: Keep away from your face.)
4. Insert the extraction tube into the circular hole of the card holder.
5. Remove the test kit from the sealed foil pouch and place it on a clean, level surface.
6. Please remove any excess mucous in the nasal cavity before sampling with the swab.
7. Unpack the swab, taking care not to touch the soft end, i.e. the absorbent tip.
8. Gently insert the swab into the nasal cavity 1-1.5 cm (generally 1 cm for children aged 2-14). Do not insert too far to avoid damaging your nostril. Slowly rotate the swab along the inner walls of the nostril 5 times or more to collect more nasal secretions. Repeat the steps in the other nostril using the same mold.
9. Insert the swab into the sponge extraction tube, gently take the tube from the paper holder, and then swirl the swab for 10-15 minutes to mix the collected sample with the sponge as much as possible.
10. Put the swab's break point near the mouth of the extraction tube, pinch the swab head with one hand on the outside wall of the extraction tube, and bend the swab to gently break it with the other hand.
11. Close the extraction tube lid and press it firmly.
12. Add 2 drops of the treated sample vertically to the sample well of the test cassette. And start the stopwatch.
13. Read the result 15-20 minutes after adding the sample. The result expires after 20 minutes.
14. All used test components are placed in the Biosafety bag, sealed, and discarded (According to local waste classification regulations)
    *Note: After completing all steps, wash your hands with disinfectant.

Interpretation of Results

• Positive: The C and T bands are present, the test result is positive. The fuchsia test line will vary in shade and intensity depending on the concentration of the antigen detected. Even a bright or faint test line is interpreted as a positive result.
• Negative: The test result is negative if only the C band is present. A positive result means that SARS-CoV-2 antigen is detected in the specimen, and SARS-CoV-2 infection is suspected, and the local epidemic prevention and control policy is followed for reporting and isolation, and corresponding medical care is requested; a negative result means that no SARS-CoV-2 antigen is detected in the specimen. However, a negative result cannot fully exclude the possibility of infection, and further inspections are performed in accordance with the requirements of local epidemic prevention and control policies when necessary.
• Invalid result: This means that the test has failed, or the test kit is invalid. Incorrect sample volume or incorrect procedural techniques are the most possible reasons for control line failure. Carefully reread the instructions for use and repeat the test with a new test device. If the problem persists, stop using the test device immediately and contact your local distributor immediately.

Warnings

For qualitative in vitro diagnosis only, read the instructions carefully before testing. For single use only. Test within the first 7 days of symptoms. Use within the valid period and store in strict accordance with the instructions. Strictly follow the instructions, do not mix different lots of test cassettes, sponge extraction tubes, etc. Incorrect testing procedure or insufficient sample volume may affect the test results. Do not use the test cassette if the bag is damaged or if any components are lost (such as insufficient desiccant, etc.). Do not drink the sponge from the tube with or without the buffer, seek immediate medical advice/attention in case of accidental ingestion. Desiccant in the bag, do not take orally. Do not directly touch the test and sample area of ​​the test cassette with your hands. Keep out of reach of children. Children under 18 must perform the test under adult guidance or professional assistance. It is recommended to use the kit within 1 hour after opening (15-30°C, humidity <60%). If the vial is damaged or the solution leaks after mixing with the swab, dispose of it as medical waste and repeat the sampling procedure for a new test. The sponge contains a small amount of preservative that may cause skin and eye irritation. If the sponge contacts the skin or eyes, wash/rinse with plenty of water. Seek medical advice/attention if irritation or a rash occurs. Observe safety measures during operation, washing or disinfecting your hands before and after use. The test kit is a qualitative in vitro diagnostic reagent. The test results are for clinical diagnosis only and should not be the sole basis for clinical diagnosis. Diagnosis is determined entirely based on clinical symptoms and other test indicators. The test kit serves merely the qualitative detection of SARS-CoV-2 antigens present in the anterior nasal specimen. A positive result only indicates the possible presence of SARS-CoV-2 antigen, but does not serve as the sole standard for judging SARS-CoV-2 infection. A negative result does not completely exclude SARS-CoV-2 infection, either due to the viral level being too low to detect or other reasons for a false negative result. Possible causes of false positives include: (1) the use of contaminated specimens and components; (2) other unverified factors that may affect the results. Possible causes of false negatives include: (1) the viral level in the specimen is too low; (2) genetic mutants at the site of the target antigen (nucleocapsid protein) to be tested; (3) other unverified factors that may affect the results. The sampling and processing method has a great influence on viral detection, and improper operation may lead to erroneous results.

Storage

The product is stored in a dry place protected from direct sunlight at 2-30°C. Do not use the expired product. The test cassette and sample sponge are disposed of as soon as possible within 1 hour of opening. Shelf life in intact packaging: 24 months.

Format

Kit containing:

• 1 test cassette;
• 1 sterilized swab;
• 1 extraction tube with sponge;
• 1 biosafety bag;
• 1 instruction manual;
• 1 card holder.