Qiagen has received emergency use authorization (EUA) from the US FDA for its newly developed COVID-19 test, the Qiastat-Dx Respiratory SARS-CoV-2 Panel test.
The Qiastat-Dx test kit can differentiate the SARS-CoV-2 coronavirus from 20 other serious respiratory infections in patients who may have similar symptoms in a single testing run of about one hour.
It 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 SARS-CoV-2 and is intended for use in laboratories certified under CLIA to perform moderate and high complexity tests.
“I am proud of our Qiagen teams working tirelessly to implement 24/7 production of test cartridges and testing components,” said Thierry Bernard, CEO at Qiagen. “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.”