INTENDED USE
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.).
CONTENTS
- Test device
- Collection device (Funnel, tube and tube tip)
- Buffer
- Package Insert
- Biosafety bag
FEATURES
- ARTG 374574
- Test Cassette
- 10 to 15 Minutes Time to Result
- 2-30ºC Storage condition
SAFETY INFORMATION
- For self-testing in the home or other environment
- Negative test results do not exclude infection with SARS-CoV-2 (COVID-19) so face masks, social distancing and good hygiene practice must be maintained.
- Positive test results or any symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.
- Follow current government health messaging regarding polymerase chain reaction (PCR) testing requirements.
- If symptoms persist, consult your healthcare professional.
- Test kits are singular use and for self-testing purposes only.
- Testing must be performed by adults or under adult supervision.
- All products must be used in accordance with the dedicated package insert and only for its intended purpose as stated