Clarigene - Model SARS-CoV-2 CE-IVD - SARS-CoV-2 - RT-qPCR Assay Kit

• High accuracy with >99.9% specificity*
• Clinical sample testing presented 100% concordance when compared to gold standard reference**
• Excellent sensitivity and precision (LOD of 5 copies per reaction); results are in concordance with an international external quality assessment panel
• Dual viral RNA targets; SARS CoV–2 Envelope gene and Nucleocapsid (N) gene for a more reliable result
• Assay uses N and E gene targets which are SARS-CoV-2 specific, meaning no cross reactivity with other Coronaviruses
• Human RNase P control designed as a true RNA control for lower false negatives
• Internal control detects improper sample collection or poor-quality sample to give an invalid result, rather than giving a negative result
• Fast turnaround time after RNA extraction
• Simple and easy to set up
• High throughput options available

Following wet lab testing, it is confirmed that the performance of the Clarigene™ SARS-CoV-2 assay is not impacted by any currently known mutations in the VU-202012/01 or OH/501Y.V2 (first identified in South Africa) strains. Click for more details on:

• VU-202012/01
• OH/501Y.V2

• Kit includes Mastermix, run controls, ROX, primers and probes
• Compatible with RNA extracted from nasopharyngeal swabs
• Assay can be easily adapted to robotic liquid handling (automated version to follow)
• 960 tests per kit for high throughput testing
• Compatible with qPCR machines capable of detection of FAM, VIC and Cy5 fluorophores