Development of an immuno-PCR Lyme disease diagnostic
Research type
Research Study
Full title
The development of a novel immuno-PCR assay for the detection of early Lyme disease
IRAS ID
311608
Contact name
Lucas J. Cunningham
Contact email
Sponsor organisation
Liverpool School of Tropical Medicine
Duration of Study in the UK
1 years, 1 months, 23 days
Research summary
This project will aim to pilot a new test for Lyme disease using immuno-PCR technology (iPCR), a method that combines pathogen protein detection with DNA amplification. Currently there is inadequate testing for Lyme disease due to multiple Borrelia species and different diagnostic markers being present at different stages of the infection. The result of these two factors means there is no single test that can be used to reliably screen for Lyme disease. The lack of a reliable diagnostic for this disease is in stark contrast to prevalence as Lyme is the most common vector borne disease in North America and Europe. Using an iPCR assay it will be possible to screen multiple antigens and discriminate between them in a single assay. The intention of this study is to pilot this approach with a focus on six Borrelia burgdorferi antigens that span early and late infection.
Individuals presenting with erythema migrans (EM) will be recruited from participatory General Practice centres across the Highlands of Scotland. Serum samples from participants will be sent to the laboratories at the Liverpool School of Tropical Medicine to help validate the immuno-PCR assay.REC name
London - Fulham Research Ethics Committee
REC reference
22/PR/1227
Date of REC Opinion
14 Oct 2022
REC opinion
Favourable Opinion