Project Title

Development and Deployment of Lateral Flow Antigen Test for COVID-19 (CoVAT)

EDCTP Project Call

Career Development Fellowship (CDF)

Project Objectives

1. Generate contextualised COVID-19 antigens and monoclonal antibodies for use in lateral flow antigen test. 2. Develop a rapid diagnostic lateral flow antigen (LFA) strip test for COVID-19 for point of care testing.

Study Design

Obervational study

Project Summary

The ongoing Coronavirus Disease 2019 (COVID-19) pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has posed a serious threat to global health and devastated world economy and lifestyles. Mass testing has been recognised as a key step in mitigation the spread of the disease since it allows for prompt clinical and well-tuned public health interventions including physical distancing measures. However, the standard test to detect SARS-CoV-2- based on a mainstay reverse transcription polymerase chain reaction (RT-PCR)- requires trained personnel, specific chemical supplies, and expensive instruments that take hours to provide results and are often available only in laboratories that provide routine, centralized services. This limits the number of tests that can be done, especially in low- and middle-income countries (LMICs). While countries in all regions have experienced testing challenges, the needs are more acute in LMICs, where fragile health systems and exclusive reliance on global supply chains have often left them unable to access much-needed tests. Therefore, there is an urgent demand for accurate rapid point-of-care diagnostic tests. In this regard, we are developing an antigen-based test that we envisage to be affordable, easy to use, and will not need skilled personnel, expensive reagents nor machines. Our development will facilitate ramping up of testing even in resource-constrained settings. Such mass testing will allow public health officials to isolate those who test positive, limit the spread of disease and help determine when it is safe to relax restrictions. Thus, our approach will contribute to saving lives and enable economies to re-open safely. Decentralizing testing will be critical to support the introduction of treatments and the rollout of vaccines. Hence, our point-of-care lateral flow antigen test under development will boost the decentralization of COVID-19 testing by making the test available in primary healthcare facilities, in community settings, and potentially even at home. To this end, we have obtained all the necessary scientific and ethical clearances from relevant institutional and national ethics review boards to conduct the study. We have assembled the research team and secured most of the materials for the laboratory experiments. We have made arrangements with relevant departmental heads of the Kenya Medical Research Institute (KEMRI) to collaborate with them in various research activities. We have synthesized cDNAs for all four target SARS-CoV-2 antigens, that is, spike protein (S), nucleocapsid protein (N), membrane protein (M), and envelope protein (E). We have constructed recombinant N plasmids and expressed the N protein in a wheat germ cell free system. Through on-job training at KEMRI and other short courses, we have obtained requisite technical skills for lateral flow test kit development, such as recombinant protein expression; cutting, spraying, and spotting of the nitrocellulose membranes with antibodies; and assembly of components of a lateral flow test kit. We continue to optimize our lateral flow antigen test platform in collaboration with KEMRI using commercially available SARS-CoV-2 S, N, M and E antibodies. Additionally, we have secured nasopharyngeal, oropharyngeal and saliva biobank samples which will be used to evaluate the performance of the LFA test kit developed in the study, using a test-negative case-control design. Essentially, our development will contribute to the achievement of the Sustainable Development Goal 3 (Ensuring healthy lives and promoting the well-being of all people at all ages), through the development of a point-of-care COVID-19 antigen test to better inform clinical and public health interventions to protect lives from the pandemic. Additionally, this venture will strengthen the domestic capacity in diagnostic technology for COVID-19 and other emerging infectious diseases since the prototype could be readily adapted to any emerging pathogen. Later in the project, we will evaluate the implementation of the test in the real world to inform strategies for rollout and scale-up for greater utilization and impact. This will create a platform for collaboration among healthcare professionals from multiple disciplines and with diverse stakeholders, institutions and pharmaceutical companies which will go a long way to boosting diagnostics research and development in Kenya and sub-Saharan Africa.

Host Organisation

Current Organisation

Mount Kenya University

Current Job Title

Postdoctoral Research Fellow

Biography