Clarigene SARS-CoV-2 CE-IVD

A CE-Marked RT-qPCR assay which detects the presence of  SARS-CoV-2 viral RNA

Benefits

• 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

*In silico analysis did not identify any potentially amplifiable targets in other respiratory pathogens.

** 48/48 positive and 24/24 negative

Variants

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

Specifications

• 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

Why Choose Clarigene™

• Low False Negatives

  Tests must include fail-safe controls that affirmatively report the presence of intact RNA and demonstrate success of all steps of the assay. A result of “no virus signal” is insufficient for clinical interpretation: controls must also say “The reaction worked as intended and would have found virus if present”. Many assays on the market use a RNase P control designed within a single exon and so detect both reverse-transcribed RNA and human genomic DNA, i.e., are unable to differentiate human genomic DNA from reverse-transcribed RNA. This inability can lead to false negative results where reverse transcription fails, but human DNA is amplified and interpreted as a successful, SARS-CoV-2 negative, test. Yourgene RNase P control is designed to span an exon boundary and hence does not detect human genomic DNA so is a true RNA control.

• High Accuracy
  
  N target is specific for SARS-CoV-2 and does not cross react with other Coronaviruses unlike some other assays on the market.
  
  
• Fast Turnaround Time
  
  Automation compatible kit format (CE-IVD) with easy to interpret data.
  
  
• Post-market surveillance
  
  Yourgene has an ongoing rigorous surveillance programme. As new variants are identified, the Company conducts both detailed in silico (computer) analysis and wet lab testing of the mutations to assess the reliability of the Clarigene SARS-CoV-2 test and will confirm any impact once results are in.

Clarigene™ SARS-CoV-2 assay publications

1. Curr Trends Med Diagn Meth. 2021 Feb 4. DOI: 10.29011/CTMDM.100110. Novel CE-Marked SARS-CoV-2 IVD Assay Solves the Problem for Genomic DNA Contamination. Ilieva VI, Flynn EM, Marvin JMC, Szynkiewicz M, Morrissey C, et al.

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