SARS-CoV-2 Antigen Rapid Test

SARS-CoV-2 Antigen Rapid Test kit For Self-Testing

(Colloidal Gold)

Test Procedure:
1. Before starting the test, wash your hands with soap and water or use hand sanitizer
2. Open the package and take out the test card.
3. Place the extraction tube on the tube holder (not be included in 1 test/box). Open the The extraction reagent bottle and pour the reagent into the extraction tube.
4. Now follow the instructions for sampling, remove the swab from its wrapper.
Note: Rip the package at the end with the arrow label / OPEN.Make sure the tip of the swab is not touched.

5. Using the sterile swab provided in the kit, carefully insert the swab into one nostril of the patient. The swab tip should be inserted up to nostril about 2 cm until resistance is met.
6. Rub the swab around the inside wall of each nostril at least 5 times. Take approximately 15 seconds to collect the sample. This is done with the same swab in the other nostril.

7.Put the swab sample into the extraction tube with extraction reagent, rotate the swab for about 10 seconds,
8. press the swab head several times against the tube wall to release the antigen in the swab as possible as can. Discard the swab according to local regulations of biohazard waste.
9. Install the beater on the extraction tube, drop 80μLthree dropsinto the sample well of the test card, and start the timer.
10. Read the result in 20 minutes. A strong positive result can be reported within 20 minutes, but a negative result must be reported after 20 minutes.
Warning: If the result is read after more than 30 minutes, the result may be invalid!

Positive result:
The presence of two lines as control line (C) and test line (T) in the result window shows positive result. Even with a very weak pink test line, the result is positive for evaluation.
In case of a positive test result:
A positive result means that you are probably infected with COVID-19. Turn around promptly ask a doctor/home physician or their local health department for further treatment to discuss. The test result must be confirmed by a PCR test. It is confirmed that you and your household should go into isolation in accordance with local guidelines.
Negative result:
In the control area (C) a color blink appears. No visible red or pink line appears in the test area (T) In case of a negative test result:
A negative result means that you probably do not have a COVID-19 infection. Please note,
that a negative result does not completely exclude a COVID-19 infection and also negative test may present an infection.Continue to maintain all applicable rules regarding contact with others as well as protection and hygiene measures. Repeat the test after 1-2 days in case of suspicion as the corona virus is not present at all stages. An infection can be accurately detected,If in doubt contact your doctor.
Invalid result:
If the control line (C) is not visible after performing the test in the result window, the
the result is considered invalid.
In case of invalid test result:
You may not have performed the test correctly. Read the instructions for use and repeat the test with a new test kit. If you have no further valid test results, please contact a doctor or a COVID-19 test centre.


Mar. 2014

CFDA approvals for five immunoassay reagents adaptable to most chemical analyzers were obtained

Feb. 2014

CFDA approvals for time-resolved fluorescence immunochromatographic analyzer were obtained

Sep. 2013

Lumigenex passed The first Food and Drug Administration by the Suzhou Municipal Quality Management System Assessment