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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.
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Rapid, high-throughput targeted testing with NeuMoDx

The NeuMoDx 96 and NeuMoDx 288 systems offer a rapid and fully automated PCR test for the detection of SARS-CoV-2, under FDA Emergency Use Authorization, that can deliver a result within an hour. A new multiplex test for influenzas A/B, respiratory syncytial virus (RSV) and the SARS-CoV-2 virus is in development. NeuMoDx systems provide an ideal solution for hospitals or central testing labs, delivering the speed and flexibility to support the large numbers of patient samples they receive.

Detect SARS-CoV-2 antibodies in just three minutes

To enable accessible and accurate SARS-CoV-2 antibody testing, QIAGEN now offers the QIAreach Anti-SARS-CoV-2 Total Test (Anti-CoV2). The Anti-CoV2 test enables rapid, qualitative detection of total antibodies to SARS-CoV-2. Features include Total Ig detection (IgA, IgM, and IgG), results in approximately 10 minutes, and the ability to test up to 8 patients simultaneously on the digital QIArearch eHub.

Access eHub Tests, instrument, Anti-CoV2, eSticks, Processing tubes, sample, Immune Response, Access Anti-SARS-CoV-2 Total, rapid, qualitative detection of total antibodies to SARS-CoV-2, digital lateral flow serological test, nanoparticle fluorescence, qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (heparin, EDTA)
Test not reviewed by the FDA
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QIAGEN support in testing protocols for emergency use

QIAGEN supports several testing protocols, including U.S. CDC, WHO, China CDC and Japan CDC, by providing test components, mid- to high-throughput automation solutions, and a multiplex syndromic detection solution. 

Product availability varies by country. Please contact your country representative or complete the support request form for further details. Please also review the protocols themselves for alternative solutions from other suppliers.

For QIAcube classic information please visit our resource hub.
RNA extraction solutions

Given the current public health emergency with COVID-19, QIAGEN and other companies are facing unprecedented demand for viral RNA isolation solutions. QIAGEN has developed dedicated solutions for viral RNA isolation that have been optimized for maximum sensitivity and reproducibility. 

We recognize that currently, scientists are seeking to use various QIAGEN kits, such as RNeasy, for SARS-CoV-2 RNA isolation from respiratory samples. It is critical to note that these kits have not been designed for isolating viral RNA, and performance of each kit varies. The user must consult the product-specific handbook or user manual. We strongly recommend using only dedicated RNA isolation products for SARS-CoV-2, such as those listed below:

Solutions authorized for use for COVID-19 testing in some regions (please check local regulations)

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For QIAcube classic information please visit our resource hub.
OEM

Tailored oligonucleotides for SARS-CoV-2 detection

In our effort to support the detection of the SARS-CoV-2 virus, OEM by QIAGEN has ramped up the production of SARS-CoV-2 specific primers and probes. We provide customized oligos defined by our customers, as well as those mentioned in protocols recommended by WHO and the CDC. To meet the high demands, we are currently prioritizing the orders of SARS-CoV-2 specific oligonucleotides. In addition, we have introduced pre-manufacturing of these oligonucleotides to enable quick supply and delivery. To order, please send your requests here.

Additional COVID-19 resources

QIAGEN solutions

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How can we support your lab?
Reach a specialist about SARS-CoV-2 resources.

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.

QIAreach Anti-SARS-CoV-2 Total testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, to perform high complexity tests.

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

The NeuMoDx SARS-CoV-2 Assay 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 of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; 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.

For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN/NeuMoDx kit handbook or user operator manual. QIAGEN handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN Technical Services (or your local distributor) or www.neumodx.com/client-resources.

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