• “Testing for respiratory viruses, particularly among hospitalized patients, is now a contemporary diagnostic standard. The QIAstat-Dx is easy to use and offers labs and patients a fast and sensitive option for sample to result testing of 20 different targets in roughly one hour.”

    – Glen T. Hansen
    Ph.D, D(ABMM), FCCM
    Director; Microbiology & Molecular Diagnostics
    Hennepin County Medical Center
  • “In absence of amplification plot and Ct values, we can’t really give them any additional information. But having these, having this information available, now I have the ability to go look at these amplification plots and tell the physician that “Hey, actually it’s influenza that seems to be the more abundant pathogen compared to the two other pathogens, so probably it’s influenza that’s causing the symptoms in the patient.””

    – Utsav Pandey
    Ph.D. MLS (ASCP)
    Children’s Hospital Los Angeles
    AMP 2019

    Hear Dr. Pandey’s presentation

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

The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for in vitro diagnostic use.

  • 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.
  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and
  • This test 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.
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