The Panbio COVID-19 Antigen Self-Test is a single-use, in vitro (outside the body) visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen (Ag). The Panbio COVID-19 Antigen Self-Test is intended to be used manually by untrained lay users (self testing) in a private setting to aid in the diagnosis of an active SARS-CoV-2 infection. Children under 14 years should be supported by an adult. The Panbio COVID-19 Antigen Self-Test is a lateral flow test that detects the nucleocapsid protein antigen of the Coronavirus SARS-CoV-2 in a swab from the mid turbinate nasal region. The product includes a test device, a bottle with buffer solution, an extraction tube/cap and a nasal swab. To use the test, buffer solution is added to the extraction tube, then a human nasal specimen is collected using the swab provided in the kit. After sample collection, the nasal swab is transferred to the extraction tube to extract the Coronavirus proteins. Next, 5 drops of extracted sample are applied to the round well on the test device. A line in the Control (C) line area within the result reading window will only become visible if the test was performed correctly. A line in the Test (T) line area within the result reading window will only become visible if Coronavirus proteins are detected. The presence of only a Control (C) line, without visible Test (T) line, indicates the coronavirus proteins are not present.
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