Testing for coronavirus

Infectious Disease | COVID-19

Testing for coronavirus
In the wake of the coronavirus outbreak, quick action is needed to develop solutions for testing a pathogen never seen before and to ultimately provide healthcare workers with options for diagnosis. Since January, QIAGEN has been providing instruments and consumables to support the detection of the virus.

At the beginning of an outbreak with a novel pathogen, detection is difficult because the new virus does not have an already identified genetic sequence. The main challenge is that a new virus has never been on the radar, leading to a need for commercial tests to be developed from scratch– and quickly. “Multiple components must be sourced from various vendors for labs to develop and validate tests,” explains Alex Vial, applications specialist at QIAGEN. It’s not a one-size-fits-all solution either: different types of tests are necessary depending on the specific situation. These cases can occur at airports, emergency rooms, and large hospital labs, for example, turning these seemingly normal settings into a hot spot for testing, and health care personnel continue to test for respiratory illnesses in a variety of ways.

Despite having different causative pathogens, many contagious respiratory illnesses have the same flu-like symptoms of fever, cough, and shortness of breath. Multiplex systems, like the QIAstat-Dx Analyzer, help labs save time and resources. In contrast to single-plex PCR tests, the multiplex PCR syndromic test can perform multiple tests at once, using specially designed respiratory panels. Syndromic testing is one of the potential solutions for containing future outbreaks.

QIAGEN has developed the QIAstat-Dx Respiratory 2019-nCoV Panel which is a new research use only (RUO) panel that can differentiate the novel coronavirus from 21 other pathogens implicated in acute respiratory syndromes. The test works by targeting two genes: ORF1b and the E gene from the SARS-CoV-2 virus. The RUO panel is currently undergoing testing at four hospitals in China after initial evaluation of clinical samples at Bichat-Claude Bernard Hospital. “ We are evaluating the new RUO panel with SARS-CoV-2 on the QIAstat-Dx Analyzer against RT-PCR testing using WHO-recommended protocols,” says Dr. Benoit Visseaux of Bichat Hospital.

QIAstat-Dx Respiratory 2019-nCoV Panel
The QIAstat-Dx Respiratory SARS-CoV-2 Panel test kit rapidly differentiates novel coronavirus from 21 other pathogens implicated in respiratory syndromes and is the first syndromic testing solution to get U.S. agency’s development support in novel coronavirus response.

Single-plex real-time PCR tests provide fluorescence measurements as amplification is occurring for a single pathogen target. In contrast, multiplex real-time PCR tests provide fluorescent measurements as amplification is occurring for multiple pathogen targets. The intensity of the fluorescent signal reflects the amount of DNA present for that pathogen target.

Real-time-PCR tests for detection of SARS-CoV-2 have been developed at QIAGEN sites in China and the United States and will be available for research use only while the company investigates potential emergency use options for the automated PCR-based test solutions. Each test has been developed to adhere to regional specifications set by the Chinese and U.S. CDC, respectively. These tests offer a complete workflow that contains all components needed to run the test, such as positive and negative controls. The Chinese version of the test is also the only commercially available test in China to include a full process control to show that the test is working properly.

The intensity of the fluorescent signal reflects the amount of DNA present for that pathogen target, and the intensity of the target can be visualized in a graph. Both single-plex and multiplex PCR tests work with fluorescence measurements. However, multiplex real-time PCR tests can help laboratories save time and resources by getting more information out of a patient sample as seen in this image of the QIAstat screen after running a panel.
We are currently adding a QIAstat-Dx Respiratory 2019-nCoV Panel which is a new Research Use Only version of the existing QIAstat-Dx Respiratory Panel. A potential key asset in this situation.
Davide Manissero, Chief Medical Officer, Infection and immune Diagnostics

Before a patient sample can be tested, nucleic acids need to be extracted from the patient sample. Patient samples can include swabs and sputum from the respiratory system. Using kits developed specifically for extracting viral NA, and sample prep instruments such as the EZ1, the extracted nucleic acids selectively bind to the surface of magnetic beads, while other contaminants stay in solution. The purified nucleic acids can be immediately used in downstream applications such as real-time PCR testing and sequencing. Official protocols for SARS-CoV-2 detection include QIAGEN extraction kits, reagents, and instruments for real-time PCR workflows. QIAGEN has an industry-leading track record in providing molecular testing solutions widely used in previous viral outbreaks such as SARS (also a coronavirus), Avian and Swine flu.

The EZ1 DSP Virus Kit is listed in the US CDC protocol for emergency use as an option to generate highly purified viral RNA from patient samples. The kit is used with the EZ1 Advanced XL platform to perform automated extraction and purification of viral nucleic acids from patient samples. The QIAamp Viral RNA Mini Kit is also listed in several emergency protocols.
We have scaled up production dramatically to respond to rapid spread of the disease, moving to 24-hour, seven-day-a-week operations at our manufacturing sites.
Thierry Bernard, CEO at QIAGEN

QIAGEN’s Global response to coronavirus

We recognize that there are concerns about allocations for certain products used in testing. As soon as this outbreak emerged, QIAGEN began responding to calls from customers in need of testing solutions. The emergence and rapid spread of COVID-19 has created extraordinary demand, straining QIAGEN’s capacity, as well as that of other companies and healthcare organizations

On March 12, customers were informed about the measures taken by QIAGEN. “We have scaled up production to respond to the rapid spread of COVID-19, moving to 24-hour, seven-day-a-week operations at two key sites, investing to expand capacity by 70% and adding staff. Our top priority is producing the QIAamp and EZ1 sample technologies recommended in the U.S. Centers for Disease Control guidelines for testing, as well as the new QIAstat-Dx cartridges. We are working closely with laboratories, hospitals and other customers around the world to assess their flexibility, timing, and quantity needs,” says Thierry Bernard, Chief Executive Officer of QIAGEN.

Supporting healthcare workers
QIAGEN supports LDT protocols for emergency use for 2019-nCoV
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