QIAstat-Dx Syndromic resources for a rapid response to COVD-19

  • The QIAstat-Dx Respiratory SARS-CoV-2 Panel

    The 2019-2020 respiratory season has brought a new and unexpected challenge in SARS-CoV-2. To support the efforts for accessible testing to meet the demands of the COVID-19 outbreak, QIAGEN developed the QIAstat-Dx Respiratory SARS-CoV-2 Panel. This version of our multiplex syndromic cartridge detects and differentiates* 21 respiratory targets, including SARS-CoV-2 from Nasopharyngeal swabs (NPS) eluted in universal transport media (UTM).

    The QIAstat-Dx Respiratory SARS-CoV-2 Panel is for in vitro diagnostic use under Emergency Use Authorization (EUA) only. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderately complexity tests.
    * Enterovirus and Rhinovirus are both detected, but not differentiated, with the QIAstat-Dx® Respiratory SARS-CoV-2 Panel.
  • QIAstat-Dx Respiratory SARS-CoV-2 Panel flyer

    The QIAstat-Dx Respiratory SARS-CoV-2 Panel contains 21 viruses and bacteria that are commonly responsible for upper respiratory infections, including the SARS-CoV2 virus.

    Download the flyer
  • Product details for the QIAstat-Dx Respiratory SARS-CoV-2 Panel

    To learn more about the QIAstat-Dx Respiratory SARS-CoV-2 panel and find additional product resources, visit the product page on QIAGEN.com.

    Product details
  • Learn more about the QIAstat-Dx Analyzer

    The QIAstat-Dx Analyzer and cartridges are designed as a closed system that contains on board all necessary reagents, enabling hands-off sample preparation.

    Download the brochure
  • QIAGEN is committed to helping you fight COVID-19

    Visit www.qiagen.com/coronavirus to learn more about how QIAGEN solutions can be used in the fight against COVID-19, or get in touch to let us know how we can support your lab.

How can we support your work?

Reach a specialist
The QIAstat-Dx Analyzer and the QIAstat-Dx Respiratory Panel are intended for in vitro diagnostic use.

QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for in vitro diagnostic use under Emergency Use Authorization Only. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.

The QIAstat-Dx Respiratory SARS-CoV-2 Panel has not been FDA cleared or approved;
The QIAstat-Dx Respiratory SARS-CoV-2 Panel has been authorized by FDA under an EUA for use by authorized laboratories;
The QIAstat-Dx Respiratory SARS-CoV-2 Panel has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Social Sharing