COVID-19 test kit Genedrive®

SARS-COV-2coronavirusclinical

The Genedrive® 96 SARS-CoV-2 Kit is a novel Polymerase Chain Reaction (PCR) assay designed to detect active SARS-CoV-2 infection in COVID-19 patients. genedrive’s proprietary “ready-to-go” solid PCR bead format eliminates the need for time consuming and error-prone reagent preparation, a requirement in all other open-platform tests. The format streamlines laboratory workflow, allowing a patient sample to be mixed with a single bead and then tested on a variety of third-party RT-PCR platforms. 96 well format for high throughput testing CE-IVD marked Simple 1-step process – No reagent preparation errors End-point PCR – Assay time is ~100 minutes Lyophilised reagents – Ambient storage (2-30°C) Human RNA control – Indicator of sample quality to provide further confidence High volume manufacturing capabilities – Meet global test demands >10,000 tests/hour The kit is intended to use viral RNA samples that have been pre-extracted from specimens such as nasopharyngeal and oropharyngeal swabs, in association with an approved nucleic acid extraction system. The Genedrive 96 SARS-CoV-2 Kit is intended to be used for the qualitative diagnosis of SARS-CoV-2 infection within symptomatic individuals. As the global spread of the coronavirus infection increases in humans a variety of diagnostic tools will be required for direct clinical care via specialist laboratories, central hospital labs and in the community.