Feasibility of a serological assay for malaria elimination (v3.0)
Research type
Research Study
Full title
Feasibility of a serological assay for malaria elimination certification
IRAS ID
194057
Contact name
Christopher Drakeley
Contact email
Sponsor organisation
London School of Hygiene & Tropical Medicine
Clinicaltrials.gov Identifier
10434, LSHTM Ethics Reference
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Following global declines in malaria transmission, it is increasingly important to develop tools better able to define low levels of residual transmission and areas where transmission is absent. Serological assays measuring specific anti-malarial antibodies provide a simple measure that documents exposure to infection over a period of time and would allow malaria control programmes to better target the use of resources. These assays are relatively cheap and can be performed as high-throughput so that thousands of samples can be assayed in a few days.
Existing commercial and research-based serological assays have been developed for screening of blood donor products rather than for epidemiological purposes. Although they may be effective for screening donations from ‘at risk’ donors, these assays may underestimate malaria exposure in natural settings. A thorough evaluation of their performance in this context has not been conducted.
This project aims to evaluate existing commercial malaria serological assays for their suitability for use in low transmission and elimination settings. To assess the performance of these assays, blood samples will be collected prospectively from patients diagnosed with malaria at HTD. Venous blood samples (~10mL) will be taken from consenting patients aged 18 years and above with confirmed malaria. Participants will be asked to return at 1, 6, 12, 18 and 24 mths after the initial visit to give additional blood samples. These samples will then be also be used to screen additional malarial antigen panels in a range of different laboratory tests (Luminex, microarrays) that might identify other malaria-specific antibodies that could provide a better marker for recent transmission events and the eventual cessation of transmission.
In addition, 2000 archived and fully anonymised blood samples from malaria positive patients currently being stored in the Malaria Reference Laboratory (MRL) at the London School of Hygiene and Tropical Medicine will also be screened for their responses to malarial antigen panels.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1904
Date of REC Opinion
25 Oct 2016
REC opinion
Favourable Opinion