QIAGEN announced it has shipped its newly developed QIAstat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China for evaluation. The company is also in the process of shipping QIAstat-Dx testing kits to public health institutions in other regions, including Europe, South-East Asia and the Middle East.
Since January QIAGEN has been providing instruments and consumables to support detection of the novel coronavirus SARS-CoV-2 in China and other markets. Official protocols for SARS-CoV-2 detection include QIAGEN extraction kits, reagents and instruments for real-time polymerase chain reaction (RT-PCR) workflows. Customers also are deploying QIAsymphony modular instruments and NeuMoDx integrated PCR systems to automate higher-throughput processing of their laboratory-developed tests for SARS-CoV-2.
“Our dedicated task force has moved very fast to develop and make available the QIAstat-Dx respiratory panel with SARS-CoV-2 detection. We are partnering closely with authorities and customers around the world to bring rapid, accurate diagnosis to the fight against this deadly infectious disease,” said Thierry Bernard, Interim CEO of QIAGEN and Senior Vice President, Head of the Molecular Diagnostics Business Area. “As we have in past health crises such as SARS and the swine flu, QIAGEN is working hard to deliver better, faster testing solutions for hospitals and public health institutions to aid in the effort to monitor and bring the outbreak under control.”
The QIAstat-Dx system was introduced in Europe in 2018 as a CE-product and cleared by the Food and Drug Administration (FDA) in the United States in mid-2019. It enables fast syndromic testing with novel Sample to Insight workflows. The system streamlines molecular testing from end to end. A technician loads a clinical sample (such as a swab) into a single-use QIAstat-Dx cartridge and places it in the analyzer. QIAGEN chemistries for sample processing and analysis are built in, and the QIAstat-Dx instrument delivers results in about one hour.
The QIAstat-Dx Respiratory 2019-nCoV Panel is a new version of the existing QIAstat-Dx Respiratory Panel for differential analysis of 21 viral and bacterial pathogens in respiratory syndromes. Once the SARS-CoV-2 genome was sequenced in January, QIAGEN developed two highly sensitive assays to detect SARS-CoV-2 targeting ORF1b and the E gene. The addition of these targets provides parallel tools for combined detection of the novel coronavirus with increased sensitivity.
The expanded QIAstat-Dx panel is currently being evaluated at the Bichat-Claude Bernard Hospital in Paris. “After more than a year of experience using the existing QIAstat-Dx Respiratory Panel to evaluate patients coming into our Emergency Department with respiratory syndromes, we are evaluating the new panel with SARS-CoV-2 against RT-PCR testing using WHO recommended protocols. The QIAstat-Dx solution can provide results in about one hour, with high sensitivity and specificity and minimal hands-on time for hospital or laboratory personnel,” said Dr. Benoit Visseaux, Associate Professor of Virology at Bichat-Claude Bernard Hospital in Paris.
The regulatory status of the QIAstat-Dx Respiratory Panel will vary by location. QIAGEN will apply for emergency authorization for marketing of the new panel from the U.S., the Korean KCDC/MFDS, and FDA and China’s National Medical Products Administration (NMPA); the panel will be available with CE-IVD marking in Europe and other markets.
