QIAGEN announced that it has obtained derogation in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) for its newly developed QIAstat-Dx Respiratory SARS-CoV-2 Panel test to be sold as an in vitro diagnostic (“IVD”) for the detection of SARS-CoV-2. At the same time, the company announced that the panel has received CE marking for Europe-wide sale as an in vitro diagnostic (IVD) test to detect SARS-CoV-2.
As the first syndromic testing solution cleared 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 an 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 Germany 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 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 approximately 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 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.