New corona mass test up to 100 times more sensitive than rapid antigen tests
by Felix Heyder
(01.07.2021) A new corona test developed at the University Hospital Bonn can analyze a large number of smears simultaneously with the help of sequencing technology and has a similarly high sensitivity as the common qPCR test. The innovative method offers great potential, particularly for systematic testing in day-care centers, schools or companies. The study results for the new corona test have now been published in the renowned specialist journal “Nature Biotechnology”.
Prof. Dr. Jonathan Schmid-Burgk, recorded while pipetting in a laboratory on the campus of the University Hospital Bonn
Photo: Felix Heyder / Bonn University Hospital
Swab material from corona tests stained blue is prepared for analysis in a sequencing device with the help of a laboratory robot.
Photo: Felix Heyder / Bonn University Hospital
In order to be able to effectively monitor and contain the infection process in the corona pandemic, in addition to vaccination, systematic testing of the population remains of central importance. This is the only way to effectively monitor the spread of the virus and to contain it through targeted measures. The innovative “LAMP-Seq” corona test, which was developed at the University Hospital Bonn (UKB), offers the possibility of regularly testing many people for the SARS-CoV-2 virus. In this way, infections can be detected at an early stage and corresponding chains of infection can be quickly interrupted.
“Our corona test” LAMP-Seq “is about 100 times more sensitive than the currently widespread rapid antigen tests and almost as sensitive and specific as the common qPCR test”, describes Prof. Dr. Jonathan Schmid-Burgk from the Institute for Clinical Chemistry and Clinical Pharmacology at the UKB discussed the properties of the test procedure, which was developed in an interdisciplinary manner with other researchers at the UKB.
“In addition, there is the high scalability of the test. Using sequencing machines, thousands of samples can be analyzed at the same time, ”says Schmid-Burgk, who was appointed to the University of Bonn in 2020 and previously worked at the Broad Institute of MIT and Harvard. The LAMP-Seq process not only detects corona infections with the original virus, but also those with new mutants of the variants alpha to delta.
Members of the ImmunoSensation2 Cluster of Excellence, the Institute for Hygiene and Public Health, Life & Brain GmbH and the German Armed Forces Central Hospital in Koblenz were among others involved in the project.
For the “LAMP-Seq” test, the Bonn scientists have adapted the already established LAMP method (“Loop-mediated Isothermal Amplification” – multiplication of the virus genome at a constant temperature) and made it compatible with sequencing machines from biomedical research. As a result, many samples can be analyzed simultaneously using the high-throughput method.
This laboratory diagnostic procedure is made possible by an innovation from Schmid-Burgk: Before thousands of samples are analyzed together in a sequencing run, each individual sample is linked to a molecular barcode. This barcode ensures that every sample can be clearly assigned even after thousands of samples have been pooled. “Subsequent testing of the entire pool in the event of a positive test result is therefore no longer necessary,” said Dr. Kerstin Ludwig, Emmy Noether group leader at the Institute for Human Genetics. This technology significantly reduces the costs per test in direct comparison to the qPCR test and makes the “LAMP-Seq” method a scalable corona mass test.
“With its high throughput and high sensitivity, the“ LAMP-Seq ”test can make a significant contribution to the screening of undetected infections. Especially in schools or companies where many people meet regularly, our corona test is ideal for systematically and preventively monitoring the incidence of infection, ”says the co-developer of the test procedure, describing the possible application scenarios for the“ LAMP-Seq ”test .
Prof. Wolfgang Holzgreve, Medical Director and Chairman of the Board at UKB, explains the benefits of the new test for corona surveillance as follows: “To effectively contain a pandemic, you have to find infected people before they infect other people. In order to achieve this goal, we need mass screenings with the highest sensitivity, with which we can get a detailed picture of existing chains of infection. This is exactly what the ‘LAMP-Seq’ corona test developed at the UKB is ideal for. “
Even smaller models of the sequencing machines used are able to analyze around 10,000 samples in a single run (duration: around ten to twelve hours). This means that the laboratory capacities are almost excluded as a limiting factor in the testing.
In several large studies (including school and employee tests) with a total of around 20,000 tests, the Bonn scientists have extensively tested, optimized and successfully validated the entire upstream and downstream logistics, from taking samples via throat swab to fully digital feedback of the test results. The documentation of the study results recently went through an independent peer review process and was published today in the renowned journal “Nature Biotechnology”.
While the Bonn researchers have currently focused their innovative method entirely on SARS-CoV-2 testing, “LAMP-Seq” can in future also be used for differential diagnostics in testing for other viruses such as influenza A and can also be quickly adapted to other pandemics . The scientists are currently working on the CE marking as part of a conformity assessment procedure in order to make the “LAMP-Seq” test available internationally in a timely manner. Until this approval has been obtained, the technically and scientifically fully validated “LAMP-Seq” method will continue to be used for pilot tests.
The scientific team received financial support from the Federal Ministry of Education and Research (BMBF) as part of the National Research Network for University Medicine (NUM B-FAST).
To the University Hospital Bonn:
The UKB cares for over 400,000 patients per year, employs over 8,000 people and has a balance sheet total of over one billion euros. In addition to the more than 3,300 medical and dentistry students, over 500 young people are trained in other health professions every year. The UKB is in 1st place among the university hospitals (UK) in North Rhine-Westphalia in the science ranking, has the fourth-highest case mix index (case severity) in Germany and had the economically most successful annual result of all 35 German UKs in 2020 and the only positive annual result of all UKs in NRW.