The COVID-19 Antigen Rapid Test (Oral Fluid) is a single-use test kit intended to detect the SARS-CoV-2 nucleocapsid protein antigens that causes COVID-19 in human oral fluid. The test is intended for use in symptomatic individuals meeting the case definition for COVID-19 within the first 7 days of symptom onset. The COVID-19 Antigen Rapid Test (Oral Fluid) obtain a preliminary results only, an aid diagnosis of COVID-19, for the final confirmation should be based on clinical diagnostic results. The COVID-19 Antigen Rapid Test (Oral Fluid) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).
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.
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, Contact your State or Territory Coronavirus testing services to get a laboratory PCR test 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