QIAstat-Dx Analyzer

The QIAstat-Dx Analyzer, combined with QIAstat-Dx assay cartridges, uses real-time PCR to detect pathogen nucleic acids in human biological samples. The QIAstat-Dx Analyzer and cartridges are designed as a closed system that contains on board all necessary reagents, enabling hands-off sample preparation. Detected real-time amplification signals are interpreted by the integrated software and are reported via an intuitive user interface.

Available panels utilize powerful QIAGEN sample and assay technologies, to deliver true Sample to Insight processing of even the most challenging samples.

QIAstat-Dx Respiratory SARS-CoV-2 Panel: This expanded version of our multiplex respiratory cartridge detects and differentiates 22 viral and bacterial respiratory targets*, including SARS-CoV-2 to support efforts to provide accessible testing to meet the demands of the COVID-19 outbreak.

QIAstat-Dx Respiratory Panel: qualitative test to analyze 21 targets for common pathogens causing acute respiratory tract infections

QIAstat-Dx Gastrointestinal Panel: qualitative test to analyze 24 targets for common pathogens causing gastrointestinal infections

* Enterovirus and Rhinovirus are both detected, but not differentiated, with the QIAstat-Dx® Respiratory SARS-CoV-2 Panel.

Simple & Fast Syndromic Testing Closer to Care!

With an intuitive workflow and the capability to process up to 48 targets utilizing real-time PCR technology, the QIAstat-Dx allows you to provide clinicians the answers that matter most.

The first assay to launch for the QIAstat-Dx is the respiratory panel (CE-IVD) which includes 21 targets for common pathogens causing acute respiratory tract infections. This panel utilizes powerful QIAGEN sample and assay technologies, to deliver true Sample to Insight processing of even the most challenging samples, including direct swab input.

The second assay to launch for the QIAstat-Dx is the gastrointestinal panel which includes targets for the 24 most commonly viral, bacterial, and parasitic pathogens that cause gastrointestinal infections.

• A true walkaway operation with less than 1-minute hands-on time
• Actionable results in about 1 hour
• 8 real-time PCR reaction chambers with 6-plex capability for a total of 48 targets
• Onboard sample prep including liquids, directly entered swabs, tissue, with inside swab resuspension and cell disruption
• Designed to suit the clinical laboratory environment and to also allow near-patient testing
• Full sample traceability with LIS integration

The QIAstat-Dx respiratory panel is a multiplexed nucleic acid test that evaluates nasopharyngeal swabs obtained from individuals suspected of having respiratory tract infections. The panel identifies the following pathogens and subtypes: adenovirus, Bordetella pertussis, Chlamydophila pneumonia, 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, Mycoplasma pneumonia, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, rhinovirus/enterovirus, and respiratory syncytial virus

QIAstat-Dx (formerly Stat-Dx DiagCORE^â) represents the next-generation in multiplex molecular diagnostic systems that enables fast, cost-effective, and flexible syndromic testing with novel Sample to Insight solutions powered by QIAGEN chemistries. The system, based on the proprietary DiagCORE^â technology, received CE-IVD marking in January 2018 and already has a significant installed base among early adopters. QIAstat-Dx is now being launched with an upgraded CE-IVD-marked respiratory panel that detects 21 pathogens. The panel is the first test in a deep and broad pipeline of planned assays for QIAstat-Dx which spans infectious diseases, oncology, companion diagnostics, and other disease areas.

The QIAstat-Dx Analyzer system’s key advantages include:

• Powerful technology capabilities: Using powerful QIAGEN sample and assay technologies, the system can deliver true Sample to Insight processing of even the most challenging samples, opening up opportunities in a broad range of application areas not possible with currently available systems. Samples include tissue samples in pathology, liquid, or difficult-to-handle sputum samples in infectious disease, with direct onboard swab processing.

• Multi-analyte capabilities: The system is the only multiplex syndromic testing system based on real-time PCR (polymerase chain reaction) technology that can process up to 48 targets, and is designed with the additional capability to process immuno-assays. These features create unmatched target and application versatility, as well as disease management options.

• Integration of real-time PCR technology: This system enables customers to precisely quantify biological targets, which is specifically important in oncology or transplantation patients and leads to improved treatment decisions. The use of real-time PCR also allows a vast portfolio of current real-time PCR tests to be portable onto the system.

• Flexible approach to results: The proprietary workflow design with an attractive cost of ownership has the potential to enable laboratories to take a tailored approach to the selective analysis and reporting of tested molecular targets. The flexible approach will represent a significant improvement over currently available systems that offer rigid panel designs, and therefore require co-processing of molecular targets found to be irrelevant in the patient sample, which may complicate reimbursement.

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 2o 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.

Reference Link

• QIAstat-Dx Analyzer Manufacturer Information
• QIAstat-Dx Analyzer Brochure