Beright COVID-19 Antigen Rapid Test (Oral Fluid)
The COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid. This test is designed for home use with self-collected oral fluid samples from symptomatic individuals who are suspected of being infected with COVID-19. The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary results only, the final confirmation should be based on clinical
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are
found in a few cases.
The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 Antigens in human oral fluid specimen.
The test device contains anti-SARS-CoV-2 antibodies.
1. Read the entire package insert prior to performing test.
2. For self-testing in vitro diagnostic use only.
3. The test is for one time use only, do not reuse the test. Do not use after expiration date.
4. Do not eat, drink or smoke in the area where the specimens or kits are handled.
5. Do not drink the buffer in the kit. Carefully handle the buffer and avoid it contacting skin or eyes, rinse with plenty of running water immediately if contacting.
6. Do not use test if pouch is damaged.
7. Wash hands thoroughly before and after handling.
8. If the result is preliminary positive, share your test result with your healthcare provider and carefully follow your local COVID guidelines/requirements.
9. Test for children and young people should be used with an adult.
10.The used test should be discarded according to local regulations.
Store the test at 35.6-86°F (2-30°C). Do not open the pouch until ready
for use. DO NOT FREEZE.
Collection device (Funnel, tube and tube tip)
Do not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.
Wash your hands with soap and water for at least 20 seconds before testing. If soap and water are not available, use hand sanitizer with at least 60% alcohol.
Step 1: Specimen collection
Remove the funnel and plastic tube; fit the funnel onto the tube. Deeply cough 3-5 times.
Note: Wear a face mask or cover your mouth and nose with a tissue when you are coughing and keep distance with other people. Gently spit oral fluid into the funnel.
The oral fluid (non-bubble) should just reach the height of scale line.
If there’s not enough oral fluid collected, repeat the above specimen collection steps.
Place the used funnel into the plastic Biosafety Bag
Step 2: Specimen preparation
Tear to open the buffer and add entire buffer to the tube with oral fluid. Fit the tube tip onto the tube. Gently squeeze the tube 10-15 times to mix well.
Step 3: Testing
Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch. Place the test cassette on a flat and level surface. Invert the tube and add 2 drops of solution to the specimen well(S) of the test device and then start the timer. Do not move the test cassette during test developing.
Step 4: Read the result at 15 minutes.
Do not interpret the result after 20 minutes.
After test is completed, place the all the components of the test kit in plastic Biosafety Bag and dispose according to local regulation. Do not reuse any used components of the kit. Wash hands thoroughly after test disposal.
1. Failure to follow the testing steps may give inaccurate results.
2. The COVID-19 Antigen Rapid Test (Oral Fluid) is for self-testing in vitro diagnostic use only.
3. The results obtained with the test should be considered with other clinical findings from other laboratory tests and evaluations.
4. If the test result is negative or non-reactive and clinical symptoms persist, it is because the very early infection virus may not be detected, It is recommended to test again with a new test 1-2 days later or go to the hospital to rule out infection.
5. Positive results of COVID-19 may be due to infection with non-SARS-CoV-2 coronavirus strains or other interference factors.