QIAGEN has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test for use in diagnosing patients infected with the novel COVID-19 coronavirus.
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 the pathogen behind the disease, Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), and is intended for use in laboratories certified under CLIA to perform moderate and high complexity tests.
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 into the instrument, and the QIAstat-Dx instrument delivers results in about one hour.
The EUA approval status comes after QIAGEN announced on March 24 that it had begun shipping QIAstat-Dx SARS-CoV-2 test kits to the United States under a new FDA policy allowing the kits to be made commercially available. QIAGEN has placed more than 1,100 QIAstat-Dx instruments worldwide in hospitals, clinics and laboratories, including over 200 in the U.S. since FDA clearance of the QIAstat-Dx Analyzer was granted in May 2019. QIAGEN received funding for this project in part from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No 75A50120C00014.
