Allplex™
2019-nCoV Assay (USA Only)

Allplex™

2019-nCoV Assay:

U.S. FDA -

Emergency Use Authorization

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.

Instructions for Use

Fact Sheet for Health Care Providers

Fact Sheet for Patients

Features

  • Powerful Performance

    PCR with high sensitivity and specificity

  • Short TAT

    Results within 1 hour and 50 minutes after extraction

  • Multiplex Real-Time PCR

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

  • Whole Process Validation

    Whole process validation from extraction to PCR by whole process control

  • Automatic Data Analyzer

    Automated data interpretation and LIS interlocking with Seegene Viewer

  • Proper Patient Care

    Quick and proper treatment provided by accurate test results

  • User-Friendly Workflow

    Convenient workflow using Seegene’s automated one platform

ANALYTES

Allplex™
2019-nCoV Assay (USA Only)

  • COVID-19 (N gene)

  • COVID-19 (RdRP gene)

  • Sarbecovirus (E gene)

  • Internal Control (IC)

SPECIMENS
  • Sputum

  • Nasopharyngeal swab

  • Oropharyngeal swab

ORDERING INFORMATION

Product:

Allplex™2019-nCoV

Assay (USA Only)

Cat No. / Size:

RP10250X / 100 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.

© 2019 by Agrivance, LLC.