COVID-19 test kit RIDA®GENE

pneumoniaSARS-COV-2coronavirus

For in vitro diagnostic use. The RIDA®GENE SARS-CoV-2 test, which will be performed on the Roche LightCycler® 480II, is a multiplex real-time RT-PCR for the direct qualitative detection of coronavirus (SARS-CoV-2) RNA from human nasal/throat swabs of people with symptoms of a respiratory infection. The RIDA®GENE SARS-CoV-2 test is designed to support the differential diagnosis of SARS-CoV-2 infections in patients with symptoms of respiratory infection in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with SARS-CoV-2 and should not be used as the sole basis for diagnosis. The product is intended for use by professional users in hospital laboratories, reference laboratories, private laboratories or state laboratories. The RIDA®GENE SARS-CoV-2 multiplex real-time RT-PCR test is compatible for use with the following real-time PCR devices: LightCycler® 480 II, RIDA®CYCLER, Mx3005P, ABI 7500 Fast Dx, CFX96™ Dx, Rotor-Gene Q. General information: At the end of December in the Chinese metropolis of Wuhan, numerous cases of pneumonia of unknown cause occurred. At the beginning of January, Chinese authorities identified a new type of corona virus (SARS-CoV-2) as the cause. The disease caused by SARS-CoV-2 is officially named COVID-19 („Corona Virus disease 2019“) and is transmissible from person to person. Worldwide, 3,925,815 cases have been reported (as of May 10, 2020). The initial cases in Germany were confirmed at the end of January 2020. In Germany 169,575 cases have been reported (as of May 11, 2020). The WHO declared an international health emergency on January 31, 2020.