Latest news on the fight against coronavirus
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COVID-19 | Updated April 1

Updates on the fight against coronavirus

From the onset of the novel coronavirus outbreak, QIAGEN has responded to the needs of healthcare workers and scientists who are working tirelessly to help conquer the virus. Latest information on this global mission below.

Background information on QIAGEN solutions, the coronavirus, and how coronavirus testing works available here.

Press releases

March 31, 2020 QIAGEN receives U.S. FDA EUA for QIAstat-Dx test kit, first and only syndromic solution integrating detection of SARS-CoV-2 coronavirus

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 coronavirus.
 

March 24, 2020 QIAGEN releases QIAstat-Dx test kit to the U.S. as first syndromic test for detection of SARS-CoV-2 coronavirus under new FDA Policy

QIAGEN announced that it has begun shipments to the United States of its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test to aid in diagnosing patients infected with the novel COVID-19 coronavirus under a new Policy of the U.S. Food and Drug Administration (FDA).
 

March 18, 2020 QIAGEN launches QIAstat-Dx test kit for detection of SARS-CoV-2 coronavirus in Europe following CE marking

The QIAstat-Dx test kit for coronavirus, the first syndromic testing solution to obtain CE marking as an in vitro diagnostic (IVD) for the detection of the virus, is now available in the European Union.
 

March 17, 2020 QIAGEN dramatically ramping up global production capacity for RNA extraction kits for use in detection of SARS-CoV-2 coronavirus

QIAGEN is ramping up production capacity for reagents to support a level of more than 6.5 million patient tests a month by the end of April 2020 and over 10 million patient tests a month by the end of June 2020.
 

March 13, 2020 QIAGEN gains BARDA funding for approval process of QIAstat-Dx test kit for SARS-CoV-2 coronavirus

The QIAstat-Dx test kit for coronavirus is the first syndromic testing solution to get U.S. agency’s development support in novel coronavirus response.
 

Feb 26, 2020 QIAGEN announces worldwide shipments of QIAstat-Dx test kits for SARS-CoV-2 research use

The QIAstat-Dx Respiratory 2019-nCoV Panel rapidly differentiates novel coronavirus from 21 other pathogens implicated in serious respiratory syndromes, and has been shipped to four hospitals in China for evaluation.

Samples of QIAGEN in the Media

Supporting healthcare workers around the world in the fight against COVID-19

QIAGEN supports several testing protocols by providing test components, mid- to high-throughput automation solutions, and a multiplex syndromic detection solution. We also support scientists seeking to better understand the SARS-CoV-2 virus with research tools, including sequencing components and tools for data analysis and interpretation. We will continue to work tirelessly on novel approaches.

QIAGEN support in current testing protocols for emergency use

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.

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 approved for use for COVID-19 testing in some regions (please check local regulations)
Research solutions

QIAGEN multiplex syndromic testing support for SARS-CoV-2*

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.*

Bioinformatics analysis of SARS-CoV-2 with QIAGEN Digital Insights

To support the efforts of clinical microbiology and public health laboratories involved in SARS-CoV-2 sequencing, QIAGEN is offering “COVID-19 emergency response licenses” for QIAGEN Ingenuity Pathway Analysis (IPA) and QIAGEN CLC Genomics ProSuite. To apply for these temporary licenses, register here.

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*The number of targets/pathogens detected by the QIAstat-Dx Respiratory SARS-CoV-2 Panels is different in different countries.

The QIAstat-Dx Respiratory SARS-CoV-2 Panels are intended for in vitro diagnostic use.

The US version of the 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.

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