Description
The ALS SARS-CoV-2 RT-PCR 4G Kit is an in vitro diagnostic medical device based on Real-Time PCR (RT-PCR) nucleic acid amplification technology for the detection of isolated SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal exudates or of nasal, endotracheal and bronchoalveolar lavage/aspirate obtained from individuals with suspected COVID-19. Together with other relevant clinical and epidemiological data, the results of the detection of viral RNA in human samples serve as an aid to the diagnosis of COVID-19 by qualified health professionals. The kit and its components should primarily be used by properly trained healthcare professionals and laboratory technicians with specific training in in vitro diagnostic procedures, in clinical analysis laboratories. It can also be used by healthcare professionals (physicians) who use the in vitro diagnostic test result to support the decision on the appropriate medical treatment, in hospital/clinical environment.