HANCOM HEALTHCARE SARS-CoV-2 Assay is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory tract fluids (e.g. oropharyngeal swabs, nasopharyngeal swabs) and lower respiratory tract specimen (e.g. sputum) from individuals who are suspected of COVID-19 by their health care provider.