Qiagen expands QIAstat-Dx testing menu with respiratory four-plex panel that differentiates between flu, RSV and SARS-CoV-2
Qiagen has announced the launch and CE-marking of the QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test for the QIAstat-Dx system to quickly identify whether patients have common seasonal respiratory infections or SARS-CoV-2.
Qiagen’s new Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test is a powerful diagnostic tool in the COVID-19 pandemic, especially in influenza like illness (ILI) or “flu” seasons. It leverages the easy-to-use QIAstat-Dx modular cartridge-based system to deliver fast results that require no additional sample preparation.
The polymerase chain reaction (RT-PCR) multiplex test detects and differentiates between influenza A and B, respiratory syncytial virus (RSV) and SARS-CoV-2 infections in about an hour – a vital capability in the fight against the COVID-19 pandemic. The viruses produce similar respiratory symptoms, making it challenging to clinicians to diagnose exactly which one a patient is suffering from to make the right treatment decisions.
“The COVID-19 pandemic has highlighted the indisputable need for accurate, reliable and time-sensitive diagnostics” says Amy S. Fox, M.D., M.S., Clinical Virologist and Vice Chair for Clinical Research, Department of Pathology, Montefiore Medical Center, Montefiore Health System, Bronx, NY. “The ability to provide rapid and accurate diagnosis through syndromic testing with multiplex PCR has significantly changed the way Infectious Disease clinicians and laboratorians manage patients and optimize workflow. An accurate early diagnosis may allow for informed, earlier, and more precise therapeutic decisions, and may aid in the implementation of public health measures such as isolation or contact precautions.”
“This new test expands the capabilities of our QIAstat-Dx system with a much-needed COVID-19 application that differentiates between respiratory infections quickly without lab infrastructure,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. “With flu season and COVID-19 case numbers still high, this test provides a crucial tool that can be used close to patients and in decentralized environments like ICUs, emergency rooms and satellite labs. By adding this new test to our growing QIAstat-Dx testing menu, we are taking another step to increase the platform’s value for customers beyond the pandemic.”
Recent publications in the Journal of Antimicrobial Chemotherapy have highlighted the value of syndromic testing for clinicians and laboratorians. The publications in the supplement highlight various considerations such as how to maximize impact of infectious diseases syndromic panels, collaboration between laboratories and antimicrobial stewardship programs, utilizing syndromic panels outside the central laboratory and what factors impact clinical decisions to utilize syndromic verses low-plex PCR. These papers can be accessed here: https://academic.oup.com/jac/issue/76/Supplement_3
Qiagen currently offers the QIAstat-Dx Respiratory+ test and the QIAstat-Dx Gastrointestinal test. It also has a strong pipeline of additional tests in development, including one for Meningitis. As of H1 2021, Qiagen has over 2400 QIAstat-Dx instruments in the market worldwide. In March, QIAGEN announced additional digital diagnostics and connectivity features for QIAstat-Dx through QIAsphere.
The QIAstat-Dx system was introduced in Europe in 2018 after receiving the region’s CE marking and in the United States in mid-2019 after being cleared by the Food and Drug Administration (FDA). The easyto- use device enables fast and cost-effective syndromic testing with novel Sample to Insight workflows.
The system streamlines molecular testing from beginning to end. A technician simply loads a clinical sample – for example, on a swab – into a single-use QIAstat-Dx cartridge and places it in the analyzer. With Qiagen chemistries for sample processing and analysis built in, the QIAstat-Dx instrument delivers results in about one hour.