The C Lungene Covid-19 Antigen Rapid Test is a SARS-COV-2 immunoassay screening device for the qualitative detection of a nucleocapsid protein, an antigen, which form part of the SARS-CoV-2 virus.

The main benefit of this Device is to find out whether a person carries the SARS-CoV-2 virus during onset of COVID-19.

Clinical Performance:
The clinical performance of CLUNGENE COVID-19 Antigen Rapid Test for self-testing was evaluated in a prospective study in Greece between June 2021 and July 2021. A total of 578 laypersons (of which, 122 within 7 days post symptom onset) were sequentially enrolled. No additional training or instructions were provided.

Self-sampling with nasal swabs and self-testing were conducted by participants using the COVID-19 Antigen Rapid Test. For comparison, to each of the participants, an RT-PCR testing was performed by professional sampling with nasopharyngeal swab. 

The COVID-19 Antigen Rapid Test showed a sensitivity of 95.1% (95% confidence interval: 89.7%-97.7%, N=122) and a specificity of 100% (95% confidence interval: 99.2%-100%, N=456) compared to RT-PCR.