In February 2020, R-Biopharm was one of the first diagnostics companies worldwide to launch a test kit for the novel coronavirus SARS-CoV-2. Now, the test has received the CE label and is thus approved for diagnostic use in the EU.
With the multiplex real-time PCR test kit RIDA®GENE SARS-CoV-2, R-Biopharm has made a valuable contribution to coronavirus diagnostics during the COVID-19 pandemic in recent months. The German Institute for Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und Information, DIMDI) has now approved the product as a CE-certified IVD product in the EU. This enables hospital laboratories, reference laboratories, private laboratories and state laboratories to reliably and rapidly detect SARS-CoV-2 specific RNA from human respiratory samples (nasal/pharyngeal swabs).
A recent study confirms the excellent performance of the test kit: According to the Dutch Institute for Health and Environment (Rijksinstituut voor Volksgezondheid en Milieu, RIVM), the test has the best performance in identifying coronavirus infections. Due to the high specificity and sensitivity, even people with only mild or no symptoms can be reliably diagnosed.
The RIDA®GENE SARS-CoV-2 provides a number of benefits to clinical laboratories:
- Best performance in the WHO assay comparison
- Maximum sensitivity and specificity
- Economically reasonable one-target detection – no confirmation testing needed
- Rapid results in only 70 minutes
- Simultaneous analysis of up to 96 samples
- Can be combined with all other RIDA®GENE assays in one run