Rapid tests for universal detection of tick-borne Lyme borreliosis (LB) and neuroborreliosis (LNB)
| Reference number | |
| Coordinator | Region Jönköpings Län - Klinisk mikrobiologi |
| Funding from Vinnova | SEK 1 154 482 |
| Project duration | October 2018 - September 2021 |
| Status | Completed |
| Venture | Eurostars |
Important results from the project
The aim of the project was to develop a reliable IVD / CE-labeled rapid test for analysis of borrelia antibodies in serum and cerebrospinal fluid. During the project, such a test has been developed and thoroughly evaluated for both analytical and diagnostic performance. The test has been launched and is now available for clinical use. The evaluation results have been compiled in a scientific article.
Expected long term effects
The rapid test for borrelia-specific IgG antibodies enables analysis of individual samples and significantly shorter response times compared to most major analysis platforms where many samples often have to be run together. The rapid test creates conditions for changed and adapted workflows in the laboratories, analysis 24/7 and also decentralization of the analysis, which can thus take place closer to the patient.
Approach and implementation
The rapid test was developed by Reagena and its basic functionality was tested and assessed in consultation with the other project partners. Subsequently, the University of Turku conducted an in-depth evaluation of the analytical performance of the test. Evaluation of the diagnostic performance was performed on Länssjukhuset Ryhov using well-characterized clinical sample panels.