Seegene’ Allplex™ SARS-CoV-2 Master Assay has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices. Allplex™ SARS-CoV-2 Master Assay is a multiplex real-time PCR assay that full screening for five notable S gene mutations (HV69/70 deletion, Y144 deletion, E484K, N501Y, and P681H) in one signal, in addition to four target genes of SARS-CoV-2 all in a single tube.
Mar 26, 2021| Allplex™ SARS-CoV-2 Master Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2 Variants I Assay. Allplex™ SARS-CoV-2 Variants I Assay is a multiplex real-time PCR assay that simultaneously detects and identifies three notable mutation sites in S gene including HV69/70 deletion, E484K and N501Y and highly conserved region in RdRP gene in a single tube.
Mar 26, 2021| Allplex™ SARS-CoV-2 Variants I Assay
Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a multiplex real-time PCR assay for primary screening of N, RdRP, and S genes for SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) A/B in a single tube. This assay also includes dual internal controls (exogenous and endogenous internal controls), which allows verification of whole test process as well as sample collection.
Jan 26, 2021| Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
Allplex™ SARS-CoV-2 Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). Allplex™ SARS-CoV-2 Assay is a multiplex real-time PCR assay to detect 4 target genes of SARS-CoV-2, a virus causing COVID-19 in a single tube. The assay enables a combination test with Allplex™ RV Essential Assay, to provide more insights for diagnosis of not only SARS-CoV-2 but also other major viruses causing respiratory infections.
Dec 07, 2020| Allplex™ SARS-CoV-2 Assay
Allplex™ RV Essential Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a One-step real-time RT-PCR assay for simultaneous detection of Influenza A, Influenza B, Respiratory syncytial virus (RSV), Metapneumovirus, Parainfluenza virus, Adenovirus, Human rhinovirus. Moreover, this assay is applied with Seegene’s proprietary MuDT™ Technology to provide individual Ct value of infected viruses in a single channel.
Nov 30, 2020| Allplex™ RV Essential Assay
Allplex™ GI-Bacteria(II) Assay has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a multiplex real-time PCR assay for detection of stx1/stx2 (Shiga toxin genes), eaeA for enteropathogenic Escherichia coli (EPEC), lt/st for enterotoxigenic E. coli (ETEC), E. coli O157, aggR for enteroaggregative E. coli (EAEC) and hypervirulent Clostridium difficile.
Oct 19, 2020| Allplex™ GI-Bacteria(II) Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay. Allplex™ SARS-CoV-2/Flu A/Flu B/RSV Assay is a multiplex real-time PCR assay that detects and differentiates N, RdRP and S genes for SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) A/B in a single tube. The assay also includes dual internal controls (exogenous and endogenous internal controls) run in the same reaction, which allow verification of the whole test process as well as sampling.
Sep 15, 2020| Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay
Seegene has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Allplex™ 2019-nCoV Assay, which detects the SARS-CoV-2 virus.Allplex™ 2019-nCoV Assay is a multiplex Real-time PCR assay to simultaneously detect three target genes of SARS-CoV-2, the virus causing COVID-19, 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. The Allplex™ 2019-nCoV Assay can be run on Seegene's automated system, which enables high throughput testing of COVID-19.
Apr 22, 2020| Allplex™ 2019-nCoV assay (USA Only)