NextGene™ SARS-CoV-2 Fast Detection Kit

  • Shortening PCR amplification time less than 1 hour
    Clinical sensitivity 100% and clinical specificity 99.54% based on the clinical performance evaluation
    Avoiding the risk of contamination by applying UDG
    Monitoring whole PCR process by endogenous IC (Internal Control)

Product Summary

MFDS approval


NextGene™ SARS-CoV-2 Fast Detection Kit is a real-time RT-PCR based in vitro diagnostic medical device designed to qualitatively detect both E gene and RdRp gene of the novel coronavirus (SARS-CoV-2) from human nasopharyngeal or oropharyngeal swab samples.

 

DETAIL

  • Detection Target
    E gene and RdRp gene of SARS-CoV-2
  • Specimen
    Nasopharyngeal swab, Oropharyngeal swab

  • Limit of Detection
    12.25 copies/µL
  • Component
    2X qRT-PCR Fast Enzyme Mix
    Oligo Mix (SARS-CoV-2)
    Positive Control (SARS-CoV-2)
    Negative Control
  • Validated Instrument
    CFX96 Dx system
  • Order No.
    RV1001A (50 rxns / kit)
    RV1001B (100 rxns / kit)

Example of Result

LIST