EGENS
SARS-CoV-2 Antigen Rapid TestKi
Description
Lateral flow immunochromatographic test. It can qualitatively detect the new coronavirus antigen in human nasal swab samples.
Add the sample to be tested in the test box well.
If the sample contains SARS-CoV-2 antigen, the viral antibody will bind to the antibody labeled with colloidal gold to form an "antibody labeled with the viral antigen" complex. The complex migrates along the test box under capillary action and combines the coated antibody in the test area to form a red band (T-line), indicating a positive result; if the sample does not contain the 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 test tube to balance at ambient temperature (15-30 °C) before testing and use them as soon as possible.
Wash hands before starting the test. Check all components for the presence of possible damage and all materials provided for integrity. Put all the materials provided on a clean and flat surface.
Pinch the top of the test tube and shake it several times to drop the solution completely into the bottom of the test tube. Remove the seal of the extraction tube containing the buffer solution. Insert the extraction tube into the circular hole on the work station.
Remove the test kit from the package and place it on a clean, flat surface.
Remove excess mucus present in the nasal cavity before sample collection. Remove the tampon from the package, take care not to touch the soft end, i.e. the absorbent tip. Gently insert the tampon into the nasal cavity to a depth of 1-1.5 cm (in general 1 cm for children 2-14 years old). Do not insert too deeply to avoid damage to the nostril. Slowly rotate the tampon against the inner walls of the nostril 5 times or more to collect as many nasal secretions as possible. Repeat the procedure also in the other nostril using the same stampon.
Insert the swab into the extraction tube and then turn the swab for 10-15 minutes to mix the collected sample with the extraction solution as far as possible.
Break the tip of the tampon near the opening of the extraction tube. Close the lid of the extraction tube and press the test tube walls.
Add 2 drops of treated sample to the test box sample. Start the timer.
Read the result 15-20 minutes after adding the sample. The result is invalid after 20 minutes.
All test components used must be placed inside the biosafety bag. The bag must then be sealed and discarded.
At the end of the test procedure, wash your hands with disinfectant.
Interpretation of results
POSITIVE: Two colored bands appear, line T and line C. The T line may have shades and intensity of different colors, to indicate a different concentration of the antigen in the sample. A bright or weak T line is also to be interpreted as a positive result.
A positive result indicates that SARS-CoV-2 antigen has been detected in the sample and it is possible that a SARS-CoV-2 infection is in place. Put yourself in self-isolation and contact your doctor immediately.
NEGATIVE: Only one colored band appears, the C line. Line T does not appear.
A negative result indicates that no SARS-CoV-2 antigen was detected within the sample. However, a negative result cannot fully exclude the possibility of infection, further checks and examinations are recommended.
NOT VALID: Line C does not appear. 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 failure to appear line C. Carefully re-read the instructions on use and repeat the test with a new test device. If the problem persists, stop using the test device and contact the local distributor immediately.
Warnings
Only for qualitative diagnosis in vitro, carefully read the instructions before the test.
Disposable: Do not reuse.
Perform the test within the first 7 days of the onset of symptoms.
Strictly follow the instructions, not the test components from different batches.
Incorrect test procedure or insufficient sample volume may compromise the test results.
Do not use the test box in case of damaged packaging or loss of components.
Do not ingest the solution contained within the extraction tube. In case of accidental ingestion, contact your doctor immediately.
Do not touch the test box sample well directly with your hands.
Keep out of the reach of children. Children under 18 years old must perform the test with 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%).
In case of damage to the test tube or leakage of the solution after the mixture with the swab, dispose of it as medical waste and carry out the sample collection again for retesting.
The solution contained in the extraction tube contains a substance that causes skin and eye irritation. If the solution comes into contact with skin or eyes, wash/rinse with plenty of water. Ask a doctor for advice in case of irritation or rash.
Pay attention to safety measures when carrying out the test, washing or disinfecting the 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 also completely determined on the basis of clinical symptoms and other indicators of the test.
A positive result only indicates 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 exclude 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 limit of detection of the test;
-The genetic mutants of the place of the target antigen (nucleocapsid protein) to be tested;
-Other unverified factors that may affect the results.
The method of sampling and processing exerts a great influence on viral detection, and a non-precise test execution can lead to incorrect results.
storage
Store in a dry place, protected from direct sunlight, at 2-30 °C.
Validity packaging intact: 24 months.
Format
The kit contains:
-1 test cassette;
-1 sterilized swab;
-1 extraction tube with extraction solution;
-1 biosafety bag;
-1 instruction manual;
-1 workstation.
Cod. D0101TE