Characterising COVID-19 occupational exposure among healthcare workers through the validation of point-of-care diagnostics
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Date
2020-06-02
Authors
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Publisher
Kamuzu University of Health Sciences
Abstract
Study type
Prospective cohort study
Problem
A substantial number of COVID-19 infections have been reported in health care workers
(HCWs) in over 50 countries. In Malawi, HCWs are particularly vulnerable, owing to the
lack of personal protective equipment and infection prevention and control measures in
healthcare facilities, fragile healthcare infrastructure and the lowest number of physicians
per population. In Malawi, COVID-19 infection amongst HCWs can have devastating
effects on an already fragile healthcare system.
A key challenge facing Malawi is the lack of access to specialist laboratory infrastructure.
If the pandemic takes off in Malawi, these diagnostic facilities will be rapidly overwhelmed.
Validation of low-cost rapid diagnostic tests will allow the accurately diagnosis of COVID-
19 infection.Validation of low-cost rapid diagnostic tests that can accurately diagnose
current COVID-19 infection. Timely diagnosis of current COVID-19 infection will enable
timely health facilities to make investigations and implement institution of containment
measures, such as quarantine and contract tracing.
Objectives
Characterise COVID-19 occupational exposure among healthcare workers in
Blantyre district
Evaluate existing point-of-care (POC) antibody tests, an in-house enzyme-linked
immunosorbent assay (ELISA) and a novel POC loop-mediated isothermal
amplification (LAMP) assay. The study will recruit 150 HCWs and 150 matching community controls at the following
healthy facilities in Blantyre district: Queen Elizabeth Central Hospital (QECH), Kameza
Isolation Centre and health centres in Blantyre urban
To determine current infection and exposure, nasopharyngeal and serum samples will be
screened for SARS-CoV-2 by RT-PCR and immune response (IgM/IgG) evaluated
respectively using in-house and commercial SARS-CoV-2 enzyme-linked immunosorbent
assays (ELISA). We will also carry out a double-blind investigation to validate a novel RTLAMP
assay using RT-PCR as gold standard. Additionally, we will evaluate the
performance of other commercially available point-of-care (POC) rapid diagnostic tests
(RDTs). We will then use bulk and single cell transcriptomic approaches to try and
understand why immunological response varies. Laboratory analyses will be performed
at College of Medicine, University of Malawi.
Expected findings
The risk of HCW to COVID-19 will be established; this will inform guidelines on
occupational safety. POC assays will be validated, which will establish the best
diagnostics for use in district hospitals and health centres, where there are no RT-PCR
facilities. Furthermore, the study will provide guidance on diagnostics for COVID-19.
Finally, we will evaluate the immunological response to SARS-CoV-2 and why this varied
between individuals and attempt to determine why some individuals exhibit symptoms.
Description
Study type
Prospective cohort study