Malaria Clinical Trial
Official title:
A Multi-Centric Evaluation of a Device for Automated Malaria Microscopy (EasyScan Go)
Light microscopy, which is based on century-old technology, remains a key indicator in drug
efficacy testing performed in the context of clinical trials for monitoring existing
antimalarial drugs or in the context of regulatory clinical trials for registration of new
drugs. It is one of the main diagnostic methods for malaria diagnosis in general, as in an
ideal setting it can provide low-cost accurate diagnosis, determine the density of parasites
in the blood, and accurately differentiate between different malaria parasite species,
characteristics vital to the implementation of global plans for drug efficacy monitoring.
Malaria rapid tests (RDTs), while useful for rapid diagnosis and case management, do not
provide information on the parasite density nor the species differentiation necessary for
research and drug efficacy assessment. Microscopy therefore retains key advantages over a
number of newer technologies, but its reliability is severely impeded by dependence on high
technical competence of the human operators as well as availability of high quality equipment
and reagents. Recent studies have demonstrated frequent poor specificity and sensitivity
associated with manual microscopy diagnostics in operational conditions. These drawbacks
constitute a major limiting factor to effective monitoring and preservation of vital
anti-malarial medicines.
Advances in digital microscopy performance and affordability have now opened the door to
potentially significant improvements in the performance of malaria microscopy, overcoming
serious deficiencies in current drug efficacy assessment, and more broadly in malaria
diagnosis and management. Global Good (GG)/Intellectual Ventures Laboratory (IVL) sponsored
by the Global Good Fund, has developed a microscope prototype consisting of low cost
components to scan and capture images from Giemsa-stained thick blood films on slides. The
captured images are analyzed with custom image analysis software developed at GG/IVL, using
algorithms that are designed for automatic malaria diagnosis, without user input. Versions of
a prototype of the device were first tested in field settings in Thailand in 2014-2015 at
clinics operated by the Shoklo Malaria Research Unit (SMRU) and then again in 2016-2017. When
compared to expert microscopy at SMRU, the performance of the device with respect to
diagnostic sensitivity (87.8%), species identification (85.6% species correctly identified)
and parasite density estimation (44% of estimates within +/-25% of reference microscopy
result) corresponded to WHO Competence Level 2. The device and the accompanying image
analysis algorithms have since been further developed and a new, third version of the
prototype is now available for testing in diverse settings with varying malaria prevalence
and user expertise.
The primary purpose of this evaluation is to quantify the diagnostic performance of the
EasyScan Go prototype in various field settings. The performance of the EasyScan Go prototype
will be assessed by scanning of negative and positive slides with the EasyScan Go and
comparing the results with expert microscopy. Plasmodium genus- and species-specific PCR will
also be performed on samples collected at some sites as an additional confirmatory test for
the detection of malaria parasites and their species if present. Testing by microscopy and
EasyScan Go will be performed in field clinic settings on Giemsa-stained slides prepared from
febrile patient blood collected from a finger-prick. Further work will be undertaken at the
WWARN laboratory in Bangkok for data analyses and for quality assurance.
Funder: Intellectual Ventures Lab/Global Good (2018) Sponser: University of Oxford Grant
refernce number:The Global Good Fund I, LLC PA No.5
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