Clungene has a high sensitivity of above 95% and TGA Approved Rapid Test Kit in symptomatic individuals.
It is a rapid chromatographic immunoassay Nasal Swab test for the qualitative detection of COVID-19.
- The results are used to identify the SARS CoV-2 antigen test within the first 7 days of symptom onset when viral shedding/viral load is at its highest
- This antigen is generally found in upper respiratory tract samples during the acute phase of infection
- Positive results suggest the presence of viral antigens, but an individual medical history and other diagnostic information are necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- The pathogen identified may not be the exact cause of the disease
- Individuals who test positive should confirm the results with a laboratory PCR test, self-isolate and notify their healthcare provider
- Negative results from individuals with symptoms longer than seven days should be treated as likely negative
- If necessary, confirm the results with a laboratory PCR test
- Negative results do not rule out SARS-CoV-2 infection
- The SARS- CoV-2 rapid antigen test is intended to support the diagnosis of a SARS-CoV-2 infection
- For in-vitro diagnostics only
- Please read the instructions carefully before performing the test
- The test can only be performed one time
- Testing by adult only or under adult supervision
- TGA approved for self-testing at home or work
- Avoid the discomfort of nasopharyngeal swab sampling
- Interpret result in 15 minutes
- Excellent performance compared to molecular methods