Qiagen, Hilden, Germany, has received FDA emergency use authorization (EUA) for its newly developed QIAstat Dx Respiratory SARS-CoV-2 panel test for use in diagnosing patients infected with the novel covid-19 coronavirus.
In a single testing run of about 1 hour, the QIAstat Dx test kit can differentiate the SARS-CoV-2 coronavirus from 2o other serious respiratory infections in patients who may have similar symptoms. The test is a multiplexed nucleic acid assay that evaluates samples such as nasopharyngeal swabs obtained from individuals suspected of having respiratory tract infections. The newly authorized panel includes assays targeting two genes used to detect the pathogen behind the disease and is intended for use in laboratories certified under CLIA to perform moderate- and high-complexity tests.
“We are pleased to begin making QIAstat Dx SARS-CoV-2 test kits available in the United States under FDA’s emergency use authorization for clinical laboratories,” says Thierry Bernard, interim chief executive officer at Qiagen. “The QIAstat Dx syndromic panel adds an important tool for clinicians.
“I am proud of our Qiagen teams working tirelessly to implement 24/7 production of test cartridges and testing components,” adds Bernard. “In addition to QIAstat Dx, we are supplying RNA extraction kits under the QIAamp and EZ1 brands, as well as numerous components and instruments for use in fighting this public health crisis around the world.”
For more information, visit Qiagen.