QIAGEN has obtained CE marking for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic for the detection of SARS-CoV-2.
As the first syndromic testing solution in the European Union for use in the coronavirus epidemic, the QIAstat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 21 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The newly approved panel includes assays targeting two genes used to detect the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2).
“We are pleased to launch the QIAstat-Dx SARS-CoV-2 test kits in Europe for clinical laboratories. QIAGEN is partnering with customers and public health authorities worldwide to provide a wide range of testing workflows, and the QIAstat-Dx syndromic panel adds an important tool for clinicians,” said Thierry Bernard, Interim CEO and Senior Vice President, Head of the Molecular Diagnostics Business at QIAGEN. “Our QIAGEN teams have responded rapidly to the spread of the COVID-19 disease, implementing 24/7 production of test components, adding staff and investing in expanding production capacity. In addition to QIAstat-Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands that have been recommended in current testing guidelines worldwide, as well as numerous components and instruments for use in fighting this public health crisis.”
QIAGEN began shipping QIAstat-Dx test kits to various markets in February 2020 for clinical evaluation and has dramatically ramped up production of the respiratory panels. The kits run on QIAstat-Dx Analyzer, QIAGEN’s Sample to Insight syndromic tests system that automates molecular analysis to deliver differential detection in about one hour. QIAGEN has placed more than 1,000 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories.
The automation system enables fast, cost-effective and easy-to-use syndromic testing with Sample to Insight workflows. A technician simply loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer. QIAGEN chemistries for DNA and RNA sample processing and analysis are built in, and the QIAstat-Dx instrument delivers results in about one hour.
In addition to SARS-CoV-2, the CE marked panel detects the following pathogens and subtypes of respiratory infections: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bocavirus, Bordetella pertussis, Legionella pneumophila and Mycoplasma pneumoniae.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of December 31, 2019, QIAGEN employed approximately 5,100 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.