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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.
Detection and identification of target genes (E gene, RdRP gene, N gene) specific for COVID-19 in a single tube
Results within 1 hour and 50 minutes after extraction
Utilization of the UDG system to prevent carry-over contamination
Whole process validation from extraction to PCR by whole process control
Convenient workflow using Seegene’s automated one platform
Accurate test results allow to quick and proper treatment
PCR with high sensitivity and specificity
Automated data interpretation and LIS interlocking with Seegene Viewer
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.
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.