Rapid Antigen Test – Nasal RAT (5)

The Biotech OnSite COVID-19 Ag Rapid Antigen Test or RAT is a single-use lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of COVID-19 suitable for self-testing and home use. The test is designed for use with self-collected samples within the first 7 days post-onset of symptoms, as an aid in identifying SARS-CoV-2 infection.

The OnSite COVID-19 Ag Self Test does not differentiate between SARS-CoV and SARS-CoV-2. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out other bacterial or viral infections. Individuals who test positive should confirm results with a laboratory PCR test, self-quarantine, and seek adequate care from their healthcare provider.

Negative results do not rule out SARS-CoV-2 infection and should be used only to support diagnosis. Negative results from patients with symptoms beyond 7 days should be confirmed with a PCR test.

This product is intended to be used for self-use by adults, between 18 and 12 years of age with adult supervision. Children under 12 should be tested by an adult. For in vitro diagnostic use only.

PRODUCT FEATURES

• Covid-19 screening at home or in the workplace
• Results in only 15 minutes
• Nasal swab for ease of use and minimal discomfort
• Pre-filled buffer tube reduces steps
• Easy to follow instructions
• 5 x tests are supplied
• Manufacturer CTK Biotech Inc (USA)
• ARTG 332961
• Very high clinical sensitivity greater than 95% PPA

Download and view the INSTRUCTIONS HERE

View the TGA APPROVAL REGISTER HERE

Please note: Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained). Follow current government health guidelines regarding polymerase chain reaction (PCR) testing requirements.