Onchocerciasis
Development of a lateral flow assay for Onchocerciasis detection
Case study
Onchocerciasis
Development of a lateral flow assay for Onchocerciasis detection
Background
BIOASTER was awarded a grant from the Bill & Melinda Gates Foundation to develop and deliver an innovative rapid test for Onchocerciasis detection affecting neglected populations in Africa
Challenges
Onchocerciasis is a debilitating disease caused by the parasitic worm Onchocerca volvulus mainly in sub-Saharan Africa where 26 million people are infected and 200 million people are at risk of contracting the disease. Currently, Onchocerciasis elimination programs rely primarily on Mass Drug Administration (MDA) of Ivermectin to eliminate transmission of O. volvulus.
A field appropriate rapid diagnostic test with high enough performance to guide onchocerciasis elimination mapping (OEM) and determine when countries can stop MDA, is urgently needed to eliminate transmission of this devastating disease in low-income countries
Solution
In partnership with Global Access Diagnostics (UK), we have developped and clinically evaluated a prototype lateral Flow assay (LFA) for detecting Onchocerciasis infection in human blood for supporting the MDA ad OEM programmes of WHO.
The primary outcome of the project was to develop and clinically evaluate a test prototype for the detection of O. volvulus antibodies in blood with high specificity, through a strategic partnership with Global Access Diagnostics, a UK-based company developing high performance, next-generation lateral flow and rapid diagnostic technologies.
BIOASTER has developed innovative recombinant antigens and engineered ov16 anti-IgG4 antibodies that have been combined with Global Access Diagnostics’s high sensitivity lateral flow technology to optimize Onchocerciasis rapid testing.
Results
Recombinant “ov16-decoy” antigens and engineered new anti-IgG4 antibodies have been designed, developed and produced allowing optimization of the LFA specificity and to decrease its cross-reactivity with other helminths overlapping with O. volvulus in African endemic regions.
Diagnostic performances of the new test have been successfully validated on a well-characterized cohort of clinical samples containing different types of parasitic worms. Manufactured LFA prototypes are currently under validation at CDC and in a multicenter field study in Africa.
Outlook
In partnership with Global Access Diagnostics, BIOASTER can be a partner of choice of the Gates Foundation to develop innovative diagnostic solutions for low & mid-income countries