Automated Microscopy Evaluation Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Endemic Diseases, Medical Campus

Khartoum, Sudan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel malaria diagnostics & tools

Diagnostic Test

Next generation microscopy tools for malaria diagnosis and medical applications

Primary outcomes

Clinical performance assessment

Time frame: up to 6 months

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
Concordance

Time frame: up to 6 months

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

Sponsors and collaborators

Lead sponsor

Foundation for Innovative New Diagnostics, Switzerland

Other

Registry information

Official study title

Clinical Evaluation of Automated Microscope Solutions for Malaria Diagnosis

Acronym: AutoMic

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Sep 22, 2020
Registry last updated: Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed