COVID-19 | Updated April 1
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.
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
MSNBCNBC’s Richard Engel covers the development of new coronavirus test kits at QIAGEN and how the company has been ramping up production to meet demand.
CNBCThierry Bernard discusses the development of a commercial coronavirus test on CNBC.
CNNThierry Bernard explains the development of the coronavirus test and QIAGEN’s work to scale up testing capacity in a live CNN interview.
NBCInside coronavirus testing labs amid shortage fears: NBC covers QIAGEN seeking fast FDA approval for the QIAstat-Dx test that provides results in about an hour.
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
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)
- QIAamp Viral RNA Mini Kit (250). This spin column product can be used manually or operated on the QIAcube.
- QIAsymphony DSP Virus/Pathogen Mini or Midi Kits. These products are operated on the QIAsymphony platform.
- EZ1 DSP Virus Kit (48), available in US/Canada and other countries, or EZ1 Virus Mini Kit v2.0 (48). These are pre-configured kits that are operated on the EZ1 Advanced XL.
- QIAamp DSP Viral RNA Mini Kit (50). This spin column product can be used manually or operated on the QIAcube (limited country availability, incl. US, S. Korea and China).
- QIAamp Viral RNA Mini Kit (250). This spin column product can be used manually or operated on the QIAcube Connect or QIAcube.
- QIAamp 96 Virus QIAcube HT Kit (5). This product consists of 5 × 96 well plates to be operated on the QIAcube HT.
- QIAamp MinElute Virus Spin Kit (50). This spin column product can be used manually or operated on the QIAcube Connect or QIAcube.
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.
How can we support your lab?
Coronavirus related stories
Testing for coronavirusLabs are using different methods to prepare and test samples of the novel coronavirus, 2019-nCoV, globally.
A rapid response to coronavirusQIAGEN is responding as quickly as possible to provide solutions to contain the spread of the coronavirus.
Is it Influenza – or something else?How QIAstat-Dx, the next generation in syndromic testing, sparked a small revolution in a French hospital.
The next generation of syndromic insights
Harness the full potential of multiplex syndromic testing and confidently provide clinical insights to patients with the highest level of versatility.
QIAGEN Digital Insights
Bioinformatics analysis of SARS-CoV-2 with QIAGEN Digital Insights
To support the efforts of labs sequencing the SARS-CoV-2 virus on the front lines of the COVID-19 pandemic, QIAGEN is offering free temporary licenses to researchers worldwide involved with COVID-19 research and response.
Redefining automated sample processing
Fully automate QIAGEN gold-standard spin-column purification procedures with the new QIAcube Connect instrument.
EZ1 DSP Virus Kit
Contains all required reagents for automated purification
The EZ1 DSP Virus Kit is ideal for automated, simultaneous purification of viral nucleic acids and bacterial DNA from 1–6 or 1–14 human biological specimens.
QIAamp Viral RNA Mini Kit
For isolation of viral RNA from cell-free body fluids
By binding viral RNA to the QIAamp silica membrane, the QIAamp Viral RNA Mini Kit simplifies purification of viral RNA from cell-free body fluids with fast spin-column or vacuum procedures. The procedure can be fully automated.
EZ1 Advanced XL
For automated nucleic acid purification
With EZ1 Advanced XL you can fully automate your nucleic acid purification from a wide range of sample types relevant for molecular diagnostics.
*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.