Automated Microscopy Evaluation Study

Foundation for Innovative New Diagnostics, Switzerland190 enrolled

Overview

Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise. To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features. In this study, a prospective evaluation of miLab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.

Study Type

OBSERVATIONAL

Enrollment

190

Conditions

Malaria

Interventions

Novel malaria diagnostics & toolsDIAGNOSTIC_TEST

Next generation microscopy tools for malaria diagnosis and medical applications

Eligibility

Sex: ALLMin age: 5 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 5 years or older * Malaria status (positive or negative) established by microscopy at the health facility, where the patient is presenting * Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17) * Willing to provide finger prick blood sample at enrollment Exclusion Criteria: * Having received antimalarial treatment during the preceding four-week period * Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Outcomes

Primary Outcomes

Clinical performance assessment

Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity) of next generation microscopy tools using nPCR as the reference test for the detection of malaria clinical cases

Time frame: up to 6 months

Concordance

Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading