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VivaDiag - Model SARS-CoV-2 -RT-PCR Detection Kit

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The VivaDiag™ SARS-CoV-2 RT-PCR Detection Kit for detecting SARS-CoV-2 is an in vitro diagnostic Real-Time reverse transcription-PCR assay for the qualitative detection of SARS-CoV-2 nucleic acids in throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) from individuals suspected of COVID-19 by their healthcare provider.

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  •  Double-target detection of genes to improve diagnosis accuracy

    The ORF1ab gene of SARS-Cov-2 will be detected by FAM channel, and the N gene ofSARS-CoV-2 will be detected by ROX channel.

  •  Negative and positive controls provide calibration for the kit

    Internal reference is used in the kit for quality control starting from sample collection.

  •  Use anti-contamination system to prevent product contamination

    dUTP and UNG enzyme are used in the kit to prevent contamination of the amplifiedproducts.

  •  With great clinical performance

    Clinical evaluation study was performed to evaluate the performance of the SARS-Cov-2RT-PCR Detection Kit. Compared with the comparator method, the PPA was 99.07%, andthe NPA was 98.97%.

  • Performance : Sensitivity: 200 copies/mL
  • Test Principle : RT-PCR
  • Sample Type : Throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF)
  • Target Genes : ORFlab, N
  • Test Time : 70 min
  • Operation Temperature : Room temperature
  • Storage Temperature : -25? to -15?
  • Shelf Life : 12 months