Optimization, upscaling and market validation of novel alphavirus-specific antibody test systems

• Applicant: Professor Dr. Jan Felix Drexler
• Subject Area: Virology
• Term: since 2025
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 558667541

Background and Objectives: Infectious diseases caused by arboviruses like alphaviruses are an increasing threat. Traditional diagnostic methods are often slow and unspecific. OPT-ALPHA aims to develop specific and sensitive serological tests for alphaviruses that are robust and easy to use. The project builds on the results of the DFG-funded predecessor project Coalition, which focused on the epidemiological characterization of emerging alphavirus infections. The Virus Epidemiology Group at Charité has already made significant progress in detecting alphaviruses, but challenges remain regarding the specificity and sensitivity of the test systems and their scalability. Project Goals: Development and validation of ELISA tests (IgG/IgM) and surrogate neutralization tests for specific and sensitive diagnosis of alphavirus infections. These tests should be usable worldwide in standard laboratories and improve clinical diagnostics and epidemiological surveillance. Work Program: 1. Production of Alphavirus Proteins: Recombinant proteins for serological diagnostics of alphaviruses will be produced and optimized. 2. Optimization of Specificity: Conserved regions in the amino acid sequence will be identified and modified through rational protein design to prevent the binding of cross-reactive antibodies. 3. Implementation and Cross-Validation: Over 10,000 samples from various cohorts will be tested to validate the efficiency and specificity of the developed test systems. 4. Application and Final Validation: The developed test systems will be thoroughly tested and optimized to ensure practical application in clinical routine. 5. Production of Prototype Test Systems: EUROIMMUN will develop ELISA prototypes and surrogate neutralization tests based on the provided antigens. 6. Design Transfer and Upscaling: The test systems will be transferred to product maturity and analytically validated. Success Criteria: Development of specific serological tests that do not require virus neutralization tests (VNT) and can be used worldwide in standard laboratories. The tests should achieve diagnostic performance comparable to VNT but be faster, scalable, and cost-effective. Utilization: Use of the test systems for acute diagnostics, specific IgG diagnostics before and after vaccinations, and for epidemiological seroprevalence studies. Successful application and validation can open new markets and improve diagnostic efficiency.

• DFG Programme: Research Grants (Transfer Project)
• Application Partner: EUROIMMUN Medizinische Labordiagnostika AG
• Cooperation Partner: Privatdozent Dr. Sebastian Ulbert