For in vitro diagnostic use. The RIDA®GENE Coronavirus Test performed on the LightCycler® 480 II real-time PCR instrument is a multiplex real-time RT-PCR for the direct qualitative detection and differentiation of coronaviruses (HKU1, NL63, 229E, OC43) and MERS-CoV from untreated human nasal/throat swabs from people with signs and symptoms of respiratory infection.
The RIDA®GENE Coronavirus Test is intended to support the differential diagnosis of coronavirus (HKU1, NL63, 229E, OC43) and MERS CoV infections in patients with symptoms of respiratory infection in conjunction with other clinical findings and laboratory findings.
Negative results do not rule out infection with coronaviruses (HKU1, NL63, 229E, OC43) and MERS, and should not be used as the sole basis for diagnosis.
The product is intended for professional use.
Coronaviruses belong to the family of Coronaviridae and are single-stranded (ss) RNA viruses. Due to their high genetic variability, individual virus species can overcome the species barrier and infect different host species. Examples of these cross-species transmissions include infections with SARS-CoV (Severe Acute Respiratory Syndrome Coronavirus), which were responsible for the SARS pandemic in 2002/2003, and the MERS-CoV (Middle-East Respiratory Syndrome Coronavirus), which appeared in 2012.
SARS-CoV cause symptoms of atypical pneumonia and claimed over 1,000 deaths during the 2002/2003 pandemic. It is believed that the original reservoir hosts are civets and bats. Even if the various routes of transmission are not fully clarified, transmission takes place primarily via droplet infection. Transmission by smear infection or via the fecal-oral route cannot be ruled out.
By 2015, more than 1,100 MERS-CoV infections were confirmed worldwide and more than 420 MERS-CoV-associated deaths were registered. The majority of these cases have been identified in the Arabian Peninsula. The original host has not yet been clearly identified for MERS either, but dromedaries are suspected to be the primary source of transmission. After an incubation period of 1 to 2 weeks, flu-like symptoms appear; severe cases can lead to pneumonia and acute respiratory distress.
In addition to SARS-CoV and MERS-CoV, the various human pathogenic coronaviruses HKU1, NL63, 229E, OC43 are the triggers of mild respiratory infections up to severe acute respiratory syndromes. Although all four coronaviruses occur globally, they are detected in different regions around the world at different times of the year.
The human coronavirus 229E (HCoV-229E) belongs to the genus Alphacoronavirus and, together with the human coronavirus OC43 (HCoV-OC43, genus: Betacoronavirus), which is often responsible for colds. Other Beta coronaviruses are SARS-CoV, MERS-CoV and Coronavirus HKU1. The last was diagnosed in 2005 in a hospitalized patient with acute respiratory syndrome and pneumonia in China.
Infections with the human coronavirus NL63 (HCoV-NL63) are similar to those of parainfluenza infections. The virus was first discovered in a child with bronchiolitis in the Netherlands in 2003 and has since been detected worldwide in young children and immunosuppressed patients with acute respiratory syndrome.
|Test format||real-time RT-PCR with 100 reactions|
|Shelf life||24 months after production|
|Sensitivity||Analytical Sensitivity : ≥ 50 RNA copies per reaction|
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.