COVID-19 test kit RIDA®GENE

flupneumoniaSARS-COV-2

For in vitro diagnostic use. The RIDA®GENE Flu & SARS-CoV-2 test, performed on the LightCycler® 480II real-time PCR instrument, is a multiplex real-time RT-PCR for the direct qualitative detection and differentiation of flu A/flu B and coronavirus (SARS-CoV-2) RNA in human nasal/throat swabs from persons with signs and symptoms of respiratory infection. The RIDA®GENE Flu & SARS-CoV-2 test is intended to support the differential diagnosis of flu A/flu B and SARS-CoV-2 infections in patients with symptoms of respiratory infection in connection with other clinical and laboratory findings. Negative results do not rule out infection with flu A/flu B or SARS-CoV-2 and should not be used as the sole basis for diagnosis. The product is intended for use by professionals working in hospital laboratories, reference laboratories, private laboratories, or public laboratories. General information: At the end of December 2019 in the Chinese metropolis of Wuhan, numerous cases of pneumonia of unknown cause occurred. At the beginning of January 2020, Chinese authorities identified a novel coronavirus (SARS-CoV-2) as the cause of these illnesses. The disease caused by SARS-CoV-2 was officially named COVID-19 (“coronavirus disease 2019”) and is transmitted from human to human. Due to this pathogen’s novelty, the epidemic rapidly evolved into a pandemic. There have already been 66,422,058 cases recorded worldwide (as of 08-Dec-20). At the end of January 2020, the first cases were confirmed in Germany as well. Germany has had 1,197,709 cases so far (as of 08-Dec-20). The WHO declared a Public Health Emergency of International Concern on 2020-01-31.