March 18, 2020—Qiagen has obtained the CE mark 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. 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 panel is a multiplexed nucleic acid test that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections and includes assays targeting two genes used to detect 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,” Thierry Bernard, interim CEO and senior vice president, head of the molecular diagnostics business at Qiagen, said in a press release. “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.”