CE-IVD COVID-19 Kits*
GENOMICA SAU has developed and sells two SARS-CoV-2 diagnostic kits with CE-IVD mark: qCOVID-19 Respiratory Combo and CLART®COVID-19.
qCOVID-19 Respiratory Combo* is a multiplex RealTime PCR kit designed to differentially detect SARS-CoV-2, Influenza A, Influenza B, and respiratory syncytial virus (RSV). This kit has been validated with nasopharyngeal samples from patients with respiratory infections, in collaboration with the Hospital Universitario La Paz de Madrid, the Hospital Clínico Universitario de Valencia and Hospital Universitario y Politécnico La Fe with a sensitivity and diagnostic specificity close to 100%.
PCR test is the reference method used for virus detection and GENOMICA’s combo kit allows to differentiate the SARS-CoV-2 virus, the cause of the current COVID-19 pandemic, from other viruses. This is important due to the similarity of the symptoms that Flu A, Flu B, and RSV infections, common respiratory diseases have. A quick and accurate diagnosis can be made, letting clinicians classify and determine the most appropriate treatment for each patient and if isolation measures when required.
The kit is based on the principle of Taqman probes. Reverse transcription and cDNA amplification reaction is carried out in one step, allowing 48 samples to be analyzed in a single run in 90 min.
CLART®COVID-19* is based on the CLART® technology patented by GENOMICA SAU. It is a multiplex RT-PCR where SARS-CoV-2 genes are amplified followed by hybridization with specific probes in low density microarrays. Due to the automation capacity of this system, up to 96 different patient samples can be processed at the same time in less than 5 hours. The kit has been validated at the National Center for Microbiology (Instituto de Salud Carlos III, Spanish National Reference Center) with a panel of 80 samples with a diagnostic sensitivity >96% and a diagnostic specificity of 98%.
*For in vitro diagnostics. Availability may be limited to professionals in certain regions or countries in accordance with local regulation.