RAPID ANTIGEN TEST COVID-19 EGENS SELF-DIAGNOSTIC QUALITATIVE DETERMINATION OF SARS-COV-2 ANTIGENS IN NASAL SWABS BY IMMUNOCHROMATOGRAPHY

Description
Lateral flow immunochromatographic test. It can qualitatively detect the antigen of the novel coronavirus in human nasal swab specimens.
Add the sample to be tested to the well of the test cassette.
If the sample contains SARS-CoV-2 antigen, the viral antibody will bind to the colloidal gold-labeled antibody to form a “viral antigen-labeled antibody” complex. The complex migrates along the test cassette under capillary action and combines with the coated antibody in the test area to form a red band (T-line), indicating a positive result; if the sample does not contain SARS-CoV-2 antigen or the content is less than the detection limit, the T-line will not appear.

How to use
Allow the test device, sample, and extraction tube to equilibrate to room temperature (15-30°C) before testing and use as soon as possible.
Wash your hands before starting the test. Check all components for possible damage and all supplied materials for integrity. Place all supplied materials on a clean, flat surface.
Pinch the top of the extraction tube and shake it several times to completely drop the solution to the bottom of the tube. Remove the seal from the extraction tube containing the buffer solution. Insert the extraction tube into the circular hole on the workstation.
Remove the test kit from the packaging and place it on a clean, flat surface.
Remove excess mucus from the nasal cavity before collecting the sample. Remove the swab from the package, taking care not to touch the soft end, which is the absorbent tip. Gently insert the swab into the nasal cavity to a depth of 1-1.5 cm (generally 1 cm for children aged 2-14 years). Do not insert too deeply to avoid damaging the nostril. Slowly roll the swab against the inside walls of the nostril 5 times or more to collect as much nasal secretions as possible. Repeat the process in the other nostril using the same stamp.
Insert the swab into the extraction tube and then swirl the swab for 10-15 minutes to mix the collected sample with the extraction solution as much as possible.
Break the tip of the swab near the opening of the extraction tube. Close the lid of the extraction tube and press the walls of the tube.
Add 2 drops of treated sample to the sample well of the test cassette. Start the timer.
Read the result 15-20 minutes after adding the sample. The result is invalid after 20 minutes.
All used test components should be placed inside the biosafety bag. The bag should then be sealed and discarded.
After completing the testing procedure, wash your hands with disinfectant.

Interpretation of results
POSITIVE: Two colored lines appear, the T line and the C line. The T line may have different shades and intensities of color, indicating a different concentration of the antigen in the sample. A bright or faint T line should also be interpreted as a positive result.
A positive result indicates that SARS-CoV-2 antigen has been detected in the specimen and it is possible that you have an active SARS-CoV-2 infection. Self-isolate and contact your healthcare provider immediately.

NEGATIVE: Only one colored band appears, the C line. The T line does not appear.
A negative result indicates that no SARS-CoV-2 antigen was detected in the sample. However, a negative result cannot completely exclude the possibility of infection, further checks and tests are recommended.

INVALID: No C line appears. The test was not performed correctly, or the test kit is invalid. Incorrect sample volume or incorrect procedural techniques are the most likely reasons for the C line not appearing. Carefully reread the instructions for use and repeat the test with a new test device. If the problem persists, discontinue use of the test device and contact your local distributor immediately.

Warnings
For qualitative in vitro diagnosis only, read the instructions carefully before testing.
Single use: do not reuse.
Test within the first 7 days of symptom onset.
Strictly follow the instructions, not the test components from different batches.
Incorrect testing procedure or insufficient sample volume may compromise test results.
Do not use the test cassette if the packaging is damaged or any components are lost.
Do not swallow the solution contained within the extraction tube. In case of accidental ingestion, contact your doctor immediately.
Do not directly touch the sample well of the test cassette with your hands.
Keep out of reach of children. Children under 18 years of age should perform the test under the guidance of an adult or professional assistance.
It is recommended to use the kit within 1 hour after opening (15-30°C, humidity <60%).
If the tube is damaged or the solution leaks after mixing with the swab, dispose of it as medical waste and collect the sample again for the new test.
The solution in the extraction tube contains a substance that causes skin and eye irritation. If the solution comes into contact with the skin or eyes, wash/rinse with plenty of water. Seek medical advice in case of irritation or skin rash.
Pay attention to safety measures when performing the test, washing or disinfecting your hands before and after the test.
The test results serve merely as a clinical auxiliary diagnosis and do not serve as the sole basis for clinical diagnosis. The diagnosis is determined entirely on the basis of clinical symptoms and other test indicators.
A positive result indicates only the possible presence of SARS-CoV-2 antigen within the sample, but should not be considered as the sole criterion for determining and evaluating SARS-CoV-2 infection.
A negative result does not completely rule out SARS-CoV-2 infection.
Possible causes of false positive results:
- use of contaminated samples and components;
- other unverified factors that may affect the results.
Possible causes of false negative results:
- the viral level in the sample is below the detection limit of the test;
- the genetic mutants of the target antigen (nucleocapsid protein) site to be tested;
- other unverified factors that may affect the results.
The sampling and processing method has a great influence on viral detection, and imprecise testing may lead to incorrect results.

Conservation
Store in a dry place, away from direct sunlight, at 2-30°C.
Validity of intact packaging: 24 months.

Format
The kit contains:
- 1 test cassette;
- 1 sterilized swab;
- 1 extraction tube with extraction solution;
- 1 biosecurity bag;
- 1 instruction manual;
- 1 workstation.

Cod. D0101TE