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 negative result
• Fast turnaround time after RNA extraction
• Simple and easy to set up
• High throughput options available (automated version to follow)

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

** 48/48 positive and 24/24 negative

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-C0V-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.

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