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COVID-19

Diagnostic testing

Syndromic testing with QIAstat-Dx

To support the efforts for accessible testing to meet the demands of the COVID-19 outbreak, QIAGEN has developed the QIAstat-Dx Respiratory SARS-CoV-2 Panel. This version of our multiplex syndromic cartridge enables detection of the SARS-CoV-2 virus that causes COVID-19 in addition to 20+ other respiratory pathogens.*

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*The number of targets/pathogens detected by the QIAstat-Dx Respiratory SARS-CoV-2 Panels is different in different countries.
QIAseq Targeted Methyl Panels
Increase lab throughput with our innovative liquid sample prep

The artus SARS-CoV-2 Prep&Amp UM Kit is an innovative liquid-based kit for SARS-CoV-2 detection. With fewer and simpler workflow steps, you can accelerate your lab's turnaround time while decreasing plastic usage, cost and hands-on time. With artus Prep&Amp, you integrate the sample preparation and the detection in a streamlined liquid workflow - getting quick results in about 2 hours*.

RNA extraction solutions

We have an extensive portfolio of RNA extraction kits for purification of high-quality RNA. You can be confident in your downstream results because our kits help deliver highly pure nucleic acid free of contaminants and inhibitors. Options are available  specific formats and throughputs, as well as for manual and automated processing.

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Reach a specialist about SARS-CoV-2 resources.

*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 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.

The NeuMoDx SARS-CoV-2 Assay is authorized under Emergency Use Authorization in the United States.

  • This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; 
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and 
  • The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 declaration is terminated or authorization is revoked sooner.

The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay is authorized under Emergency Use Authorization in the United States.

  • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
  • This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and/or Respiratory Syncytial Virus, not for any other viruses or pathogens; and
  • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

The artus SARS-CoV-2 Prep&Amp UM Kit has been validated but is pending Emergency Use Authorization by the FDA.