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.
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
Disclaimers:
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
Overview
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.
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.
Ready-To-Go
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.
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.
High Volume Manufacturing
Manufacturing capabilities that can meet global test demands. More than >10,000 tests can be created per hour.
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
| Description | Specifications |
|---|---|
| Operator steps
|
One |
| Storage | 2-30°C |
| Shipping conditions | Ambient (2-30°C) |
| Gene target
|
Species-specific genetic sequences within the E and N genes of the SARS-CoV-2 genome |
| Time to result |
~100-119 minutes* |
| Sample type |
RNA extract from upper respiratory specimens |
| Format |
Plate |
| Pack size |
1 plate x 96 reactions |
| Starting material | RNA |