Clungene rapid test for the qualitative detection of COVID-19 antigen in Nasal Swab in symptomatic individuals

• The COVID-19 Antigen Rapid Test Cassette (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Nasal Swab

• 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

• For self-testing 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

• Easy to operate

• Interpret result in 15 minutes

• Excellent performance compared to molecular methods

• Packed in retail box

SPECIFICATIONS

• Type: COVID-19 Rapid Antigen Test

• Presentation: Nasal swab

• Approval: TGA Approved for home use

• Approval Number: ARTG 333341

• Accuracy: Relative sensitivity: 95.1%; Relative Specificity: 100%

• Time to results: Read the results at 15 minutes

• Store as packages in the sealed pouch between 4-30 deg C

• Pack of 5 kits

• OEM: TESTKITAA5