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.
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
CE-IVD: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC).
US EUA: Validation of this test has not been reviewed by FDA. Review under the EUA program is pending. For In Vitro Diagnostic (IVD) Use. Rx Only.
Choose a Genedrive 96 SARS-CoV-2 Model
Genedrive® 96 SARS-CoV-2 Kit Features
Genedrive® 96 SARS-CoV-2 Kit is a Polymerase Chain Reaction (PCR) assay intended to use viral RNA samples that have been pre-extracted from specimens for the qualitative diagnosis of SARS-CoV-2 infection in symptomatic individuals.
Solid PCR bead format eliminates the need for time-consuming and error-prone reagent preparation. The lyophilized reagents are stored at ambient temperature allowing for immediate use, no need for thawing reagents.
Manufacturing capabilities that can meet global test demands. More than >10,000 tests can be created per hour.
Genedrive® 96 SARS-CoV-2 Kit Specifications
|Shipping conditions||Ambient (2-30°C)|
||Species-specific genetic sequences within the E and N genes of the SARS-CoV-2 genome
|Time to result
||RNA extract from upper respiratory specimens
||1 plate x 96 reactions