Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

The Rapid SARS-CoV-2 RNA Test is a qualitative in vitro nucleic acid reverse transcription loop mediated isothermal amplification (RT-LAMP) test for the detection of N gene and O gene of SARS-CoV-2 virus in oropharyngeal swab specimens from individuals suspected of COVID-19 infection. The Rapid SARS-CoV-2 RNA Test is intended for use by medical professionals, trained operators, and clinical laboratory technicians. The Rapid SARS-CoV-2 RNA Test is required to be used in combination with Gene Scoper (HG-I202/HG-I204)