Lateral Flow Assay and Reader for Malaria Detection version 1.0
Research type
Research Study
Full title
Assessment of novel sensitive malaria-detecting lateral flow assay (LFA), and digital reader for enhancement of existing and prototype LFAs, as tests for parasite detection and monitoring of parasite clearance.
IRAS ID
211950
Contact name
Peter Chiodini
Contact email
Sponsor organisation
University College London Hospital Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Malaria is a tropical disease caused by parasites infecting a person’s red blood cells. One method for diagnosis of malaria involves a blood test using lateral flow assays (LFAs), also known as rapid diagnostic tests (RDTs). High sensitivity LFAs are of interest for screening of asymptomatic individuals in areas attempting malaria elimination or preventing re-introduction. Possible paths include the use of very sensitive visually read assays and/or the addition of a reader enhancing the detection of a positive test line on a novel or existing assay. It is important to understand how long a highly sensitive test will remain positive after treatment. The study aims to compare the assays at time of first sampling and follow up malaria-positive patients post treatment with repeat blood tests for malarial parasites. The follow-up period will be up to twelve weeks post treatment (with treatment end point being determined by slide microscopy as per current guidelines). Sampling will cease after two consecutive negative LFA results.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1678
Date of REC Opinion
7 Nov 2017
REC opinion
Further Information Favourable Opinion