German molecular diagnostics company Qiagen has announced the CE mark approval and roll-out of QIAreach QuantiFERON-TB test for tuberculosis (TB) infection.
The company has developed the test as a portable device for ultrasensitive digital detection of TB infection, leveraging its QuantiFERON-TB Gold Plus technology.
With an end-to-end, simple and cost-effective workflow, the TB test would increase the access to reliable Interferon Gamma Release Assay (IGRA) testing.
Also, it is designed to enhance the access to TB testing in regions with high burden of the disease, and with limited access to lab infrastructure and testing resources, said the company.
Qiagen CEO Thierry Bernard said: “With QIAreach QuantiFERON-TB we have taken a great step towards leaving no one behind when facing a deadly disease like tuberculosis that is preventable and curable.
“With this groundbreaking new way to detect TB infections we can aid to prevent patients, especially those in high burden countries, from developing the active form of TB.
“It combines QIAGEN’s proven QuantiFERON-TB technology with a very portable and field-friendly digital device to deliver extremely reliable results without the need for complex laboratory infrastructure at effective cost.”
Unlike traditional TB skin test, QuantiFERON-TB uses blood samples to detect interferon-gamma molecules released from T-cells that are exposed to TB bacteria.
The QIAreach TB test is designed to run on the digital eHub and eStick system, and delivers results within 20 minutes after sample incubation, requiring only one patient visit.
In clinical studies, the test showed superior level of agreement and high sensitivity, compared to the company’s gold standard IGRA product QuantiFERON-TB Gold Plus.
The studies were conducted at Nagasaki Genbaku Isahaya Hospital in Japan, and the six Zambart project sites in Zambia.
Qiagen said it will work together with distribution partners, along with the Stop TB Partnership’s Global Drug Facility, to ensure affordable access of the test.
Stop TB partnership executive director Lucica Ditiu said: “Lack of access to the latest diagnostic tests is just one of the reasons the world is not on track to meet UN Sustainable Development goals to end TB.
“The Covid-19 pandemic saw nine of the countries with the most TB cases cut diagnosis and treatment of the disease by 16-41 percent, setting us back to 2008 levels.
“Without rapidly rolling out new tools, the commitments made by heads of states to find and treat 40 million people by the end of 2022 will not be met.”
