By optimizing the basophil activation test (BAT), a team of scientists at the Borstel Research Center is creating an innovative measurement method that detects allergies quickly and accurately. Unlike conventional methods, it can detect an actual allergic reaction, not just sensitization. The team led by DZL scientist Prof. Dr. Uta Jappe published the results in the journal Allergy in December 2021 and applied for a patent. Negotiations with an industry partner are underway to bring the method into routine diagnostics.
Allergies are among the most common chronic diseases in Europe. According to the Robert Koch Institute, more than 20 percent of children, more than 35 percent of women and 24 percent of men develop at least one allergic disease. This can massively limit the quality of life. Reliable diagnostics and adequate treatment are therefore enormously important for those affected.
Standard diagnostics with weaknesses
Allergists and dermatologists usually use skin prick tests and detections of IgE antibodies in the blood to investigate whether someone has come into contact with certain allergens (e.g. birch pollen). While these methods are easy to use, they only show half of the truth: although they can detect a specific sensitization, this is just the proof of a reaction of the immune system. However, they do not show whether this results in clinically relevant symptoms of a real allergy. In order to prove this in unclear cases, an additional provocation test with the allergen source is currently used. However, this test can cause considerable side effects in patients, including anaphylactic shock.
An alternative is the basophil activation test (BAT), which mimics the allergic reaction in a test tube with blood samples. Basophils are blood cells that are activated as part of the allergic reaction. Until now, however, the test could not be used on a widespread basis: Since the patients' blood samples had to be processed immediately after collection, physicians without their own laboratories could not evaluate the BAT. In addition, there were no automated analytical procedures, which meant that the effort involved was disproportionately high. Last but not least, there was no standardized protocol for the BAT.
Optimized procedure could become routine
Uta Jappe's research group addressed all these problems together with Dr. Jochen Behrends' team (Central Unit Fluorescence Cytometry). By optimizing the method, the Borstel scientists were able to establish a protocol that has the potential to replace expensive and risky provocation tests and predict the severity of the allergic reaction. The methodology reduces personnel and material costs and uses a high-throughput procedure in a fluorescence flow cytometer. Validation already performed in a nationwide interlaboratory study showed that the protocol is feasible regardless of instrument type and provides very accurate results. In the meantime, a patent application has been filed for the optimization of the BAT. "The possibility of using this safe and precise test in routine diagnostics has led to a cooperation with a company based in Germany and has also aroused interest among large internationally operating companies," says Uta Jappe. "Being able to use the BAT as a standard method in the clinic would represent a major advance in the treatment of our patients."
The work in this project was partly funded by the Disease Area "Asthma and Allergies" of the DZL.
Original publication: Innovative robust basophil activation test using a novel gating strategy reliably diagnosing allergy with full automation.