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  • Real-time
    PCR
  • Received
    FDA-EUA

Allplex™
2019-nCoV Assay (USA Only)

Simultaneous detection and identification of 3 target genes specific for COVID-19  

Allplex™ 2019-nCoV Assay is a multiplex Real-time PCR assay for simultaneous detection of 3 target genes of SARS-CoV-2 in a single tube. The assay is designed to detect RdRP and N genes specific for SARS-CoV-2, and E gene for all of Sarbecovirus including SARS-CoV-2.

Features

  • Multiplex real-time PCR

    Detection and identification of target genes (E gene, RdRP gene, N gene) specific for COVID-19 in a single tube

  • Short TAT

    Results within 1 hour and 50 minutes after extraction

  • Whole process validation

    Whole process validation from extraction to PCR by whole process control

  • User-friendly workflow

    Convenient workflow using Seegene’s automated one platform

  • Proper patient care

    Accurate test results allow to quick and proper treatment

  • Powerful performance

    PCR with high sensitivity and specificity

  • Automatic data analyzer

    Automated data interpretation and LIS interlocking with Seegene Viewer

  • UDG system

    Utilization of the UDG system to prevent carry-over contamination

  • Analytes

    Allplex™
    2019-nCoV Assay (USA Only)

    • Sarbecovirus (E gene)
    • SARS-CoV-2 (N gene)
    • SARS-CoV-2 (RdRP gene)
    • Internal Control (IC)
  • Specimens

    • Sputum
    • Nasopharyngeal swab
    • Oropharyngeal swab
    • Anterior nasal swab
    • Mid-turbinate
  • Ordering Information

    Product
    Cat No. / Size
    Allplex™ 2019-nCoV Assay (USA Only)
    RP10251Y / 50 rxns
    RP10250X / 100 rxns
    RP10252W / 124 rxns

Result

The highlighted result represents positive results for E gene of Sarbecovirus in FAM channel, RdRP  gene and N gene of COVID-19 in Cal Red 610 and Quasar 670 respectively. 

Note

Allplex™ 2019-nCoV Assay has not been FDA cleared or approved. This test has been authorized by FDA under an emergency use authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.