GDR17 Feb 2021 08:19
SARS-CoV-2 Detection
Assays: Genedrive® 96 SARS-CoV-2 Kit
The Genedrive® 96 SARS-CoV-2 Kit, a novel Polymerase Chain Reaction (PCR) assay designed to detect active SARS-CoV-2 infection in COVID-19 patients, uses a “ready-to-go” solid PCR bead format that eliminates the need for time-consuming and error-prone reagent preparation, a requirement in all other open-platform tests.
Genedrive® 96 SARS-CoV-2 Kit
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 in symptomatic individuals.
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
Lyophilized 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