ViennaLab successfully developed and launched a one step real-time reverse transcription PCR (RT-PCR) assay for the highly sensitive detection of SARS-CoV-2

With financial support from the Vienna Business Agency’s Innovate4Vienna program, ViennaLab Diagnostics developed the SARS-CoV-2 RealFast™ Assay. The new CE/IVD labeled test has recently been launched and is already used by many national and international laboratories.

The SARS-CoV-2 RealFast™ Assay is a multiplex real-time reverse transcription PCR (RT-PCR) test for an accurate detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The presence of SARS-CoV-2 specific RNA in respiratory tract specimens is associated with the Coronavirus Disease 2019 (COVID-19). The new RealFast™ Assay allows for the simultaneous analysis of two viral target genes (N and RdRP/ORF1ab) specific to SARS-CoV-2, plus an endogenous human control gene (ACTB) in a one-tube reaction. The protocol is fast and applicable on a broad range of common real-time PCR instruments.

The SARS-CoV-2 RealFast™ Assay is highly sensitive, with a limit of detection (LoD) of 10 virus copies per reaction. It is validated and intended to be used on RNA extracted from naso-/oropharyngeal swab samples of patients suspected of carrying SARS-CoV-2 infection. In collaboration with the Austrian Institute of Technology (AIT), the protocol has been further optimized for short PCR cycles and for the application on unpurified swab and gargling samples.

Special Assay Features:

  • virus gene targets: N and RdRP/ORF1ab

  • human ACTB gene (endogenous control)

  • LoD: 10 copies per reaction

  • CE/IVD

About ViennaLab Diagnostics GmbH

ViennaLab Diagnostics was established 1990 and focuses on the development and production of human in-vitro diagnostic (IVD) tests. StripAssays®, RealFast™ and next generation sequencing (NGS) assays are marketed through an international network of distribution partners. ViennaLab kits are CE/IVD labeled and meet ISO 13485 standards. In 2020 the company fully joined the BioVendor Group, an international diagnostics holding with headquarters in Brno, Czech Republic.

Contact

Christian Oberkanins, CTO
ViennaLab Diagnostics GmbH
Gaudenzdorfer Guertel 43-45
1120 Vienna, Austria
Tel: +43 1 8120156
E-Mail: oberkanins(at)viennalab.com
https://www.viennalab.com

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