From the onset of the novel coronavirus outbreak, QIAGEN’s dedicated global teams have been working around the clock to ensure the availability of existing testing solutions and to develop new SARS-CoV-2 tests to address international testing needs.
Today, we offer a comprehensive portfolio of SARS-CoV-2 testing solutions on the market, covering the needs of clinical and research customers, from manual to automated sample processing, low to high throughput, single-plex to multi-plex, and from active infection testing to the detection of previous viral exposure.
Stay up to date with the latest news, product developments and stories covering our global efforts in the fight against COVID-19.
Latest news
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December 7, 2020QIAGEN launches SARS-CoV-2 test for T cell responseQIAGEN to launch QuantiFERON SARS-CoV-2 for research into causes, spread and control of COVID-19 through T-cell response. -
Syndromic testing | QIAstat-DxAvoiding repeat hospital visits with syndromic testingThe team at Mako Medical ensure fast test results to vulnerable senior communities, knowing that delays can present a real dilemma for patients with little time for diagnoses. -
November 16, 2020QIAGEN launches NeuMoDx multiplex testQIAGEN adds the NeuMoDx multiplex test to complete range of SARS-CoV-2 testing solutions in Europe and other markets. -
November 11, 2020QIAGEN launches easy-to-use antigen testThe QIAreach SARS-CoV-2 Antigen Test is an digital, easy-to-use solution that can analyze over 30 samples per hour on a portable device. -
Infectious disease | TuberculosisBattling tuberculosis in the time of COVID-19Dr. Story brings tuberculosis testing and treatment to susceptible homeless communities knowing that a disruption in TB testing during COVID would have major consequences. -
October 5, 2020Sample preparation and detection steps in a single kitQIAGEN to complement COVID-19 testing portfolio with novel QIAprep& kit that simplifies and accelerates PCR analysis for research applications. -
August 24, 2020QIAGEN launches digital test for SARS-CoV-2 antibody detectionQIAreach Anti-SARS-CoV-2 Total is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies (IgA, IgM, IgG). -
August 18, 2020QIAGEN expands integrated coronavirus NGS and software solutionsQIAseq SARS-CoV-2 Primer Panel converts viral RNA samples into libraries ready for sequencing. -
Infectious Disease | COVID-19Achieving production goals in record timeMaine company pushes the limit and does the impossible to design a spin column machine in record time to help in testing for coronavirus. -
Infectious Disease | COVID-19Suppliers behind the front lines of COVID-19Suppliers are finding novel solutions to help diagnostic companies like QIAGEN ramp up production to provide urgently needed COVID-19 testing materials. -
Infectious Disease | COVID-19Ensuring critical deliveries when every minute countsUPS teams up with QIAGEN to deliver coronavirus testing solutions to curb the SARS-CoV-2 pandemic. -
March 31, 2020QIAGEN receives FDA EUA for syndromic test including SARS-CoV-2QIAstat-Dx syndromic testing system can differentiate novel coronavirus from 20 other respiratory targets. -
Previous datesAll previous press releases are published in our newsroom archiveRead up on our previous press releases or peruse our media archives.
In the media
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CNBCThierry Bernard breaks down how QIAGEN’s new rapid coronavirus test works, and what it means for testing moving forward. -
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. -
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.
The QIAstat-Dx Respiratory SARS-CoV-2 Panel is intended for in vitro diagnostic use.
In the United States:
- 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.
In the United States:
QIAreach Anti-SARS-CoV-2 Total and QIAreach SARS-CoV-2 Antigen 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.
QIAreach Anti-SARS-CoV-2 Total Test:
- 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
QIAreach SARS-CoV-2 Antigen Test:
- The QIAreach SARS-CoV-2 Antigen Test has been validated but FDA's independent review of this validation is pending.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.