Using the Ebola outbreak, Charité researchers provide a blueprint for rapid evaluation of new diagnostic tests
Led by Charité – Universitätsmedizin Berlin, researchers have successfully evaluated the quality of new diagnostic tests for the novel Bundibugyo Ebolavirus in record time. The team’s approach charts a new route to fast‑yet‑rigorous approval of PCR tests during outbreaks and pandemics. Here, study lead Prof. Christian Drosten answers questions about the research findings.
What was the research question or scientific inquiry behind your study?
PCR diagnostics must be available quickly during outbreaks. A Charité team has shown that a network of academic labs can efficiently perform the quality validation needed for regulatory approval.
During the COVID‑19 pandemic we rapidly developed a PCR test for the new virus, it was the first test of its kind worldwide. Because the assay design was made publicly available and its performance had already been verified, manufacturers could replicate it and bring it to market quickly. That rapid roll‑out made broad testing possible already in the first wave, helping to control the spread.
Since then, the EU has tightened regulations for new diagnostics; every new test now requires its own validation study. Many fear that these longer approval pathways could hinder rapid responses to the next pandemic, since such studies usually take several months. The current Bundibugyo Ebola outbreak in the Congo is exactly such a scenario where new tests were urgently needed. That’s why we looked for ways to rapidly assess the quality of new tests.
How did you approach the topic?
On May 20, Charité admitted a U.S. patient who had contracted Ebola while in the Congo. From a throat swab we isolated the virus’s genetic material and developed what’s known as a reference standard—a benchmark that any diagnostic test must be able to detect. At the same time we assembled an international network of nine laboratories, encompassing high‑containment BSL‑4 facilities and major university hospitals. The network includes members of the German National University Medicine Network (NUM), the German Center for Infection Research (DZIF), and several European research consortia. We shared the reference standard with these labs and, using multiple geographically distributed sample archives, evaluated the reliability of four candidate diagnostic tests from two manufacturers.
What did you discover?
In just two weeks we completed a thorough evaluation of all four tests, both technically and with clinical samples. The manufacturers now have the data they need to apply for emergency use authorization for their tests. We very much hope that our efforts will help make reliable tests for the Bundibugyo virus available quickly, helping to curb the outbreak in the Congo.
What’s your takeaway?
Our study demonstrates a new approach to rapidly establishing rigorous, high-quality testing during a pandemic. This decentralized approach shortens the time between outbreak detection and the availability of diagnostics, especially for dangerous pathogens or in situations where clinical samples are scarce. This underscores how crucial effective collaboration is between publicly funded healthcare institutions and companies in the pharmaceutical and biotech sectors during infectious-disease emergencies.
However, in such situations public institutions need funding to specifically accelerate market approval of industry candidate products. This operational model—which is now standard in vaccine development and enabled by substantial public funding—is missing in the field of diagnostics.
Links
- Link to the original article on the Lancet website
- Link to the Charité website of the Institute of Virology
Source