Clinical validation of new diagnostic method for tick-transmitted infections

Purpose and goal

A technically verified and primarily validated whole new ELISA prototype for screening diagnostics of rickettsia infections has been developed based on tests of retro- and prospectively collected patient serum in collaboration with clinical units in the country and in the Uppsala region. Seroprevalence, lab and journal data have been compiled and published in an international journal for the group of patients tested. A first update of national guidelines for the investigation of rickettsia infection has been made. A larger collection with tested sera and other samples is stored.

Expected results and effects

The recombinant ELISA prototype provides high sensitivity and reproducible results, which together with ease of use makes it suitable for screening diagnostics. Following extended validation and standardization, it can be launched in a domestic market and also in an international market after deeper market analysis and testing of serum from other countries, Patient samples have shown seroprevalence in line with Borrelia and symptom that motivate testing prior to clinical decisions. Increased interest from clinics and laboratories has contributed to collaborations and studies.

Planned approach and implementation

The project has been carried out in collaboration between Alpha Biotech AB, a research group at Uppsala University and Infection Clinics in Uppsala and Falun and a health center in Dalarna. All partners and employees have contributed according to the project plan, enabling both technical development, diagnostic testing of relevant samples and an initial evaluation of clinical manifestations. The interaction between the company, research and clinicians have been a creative combination that has accelerated both technology development and clinical application of diagnostics.