The CLEO™ COVID-19 Molecular Test is a molecular in vitro diagnostic test for the qualitative detection of nucleic acid from the novel coronavirus SARS-CoV-2, which causes COVID-19. This test is authorized for professional use only with anterior nasal (nasal) swab samples from individuals suspected of COVID-19. Principles of the Procedure The CLEO™ COVID-19 Molecular Test uses fluorescence reverse transcription loop-mediated isothermal amplification (RT-LAMP) technology to conduct in the Open Reading Frame 1ab (ORF1ab) and N (Nucleocapsid) regions of the SARS-CoV-2 genome. The CLEO™ test also identifies nucleic acids from human genes that serve as controls for samples. Isothermal amplification takes place in a disposable CLEO™ Test Cartridge. The gene is amplified by isothermal amplification from the sample in the cartridge, and when the SARS-CoV-2 specific probe is bound to the amplified gene, a fluorescence signal is generated, which is measured by the fluorescence meter in the CLEO™ ONE device. The measured result value is transmitted to the CLEO ™ ONE app, and through the app's analysis algorithm, you can check whether you are infected with COVID-19.