Automated Microscopy Evaluation Study (AutoMic)

Foundation for Innovative New Diagnostics (FIND)

Status

Completed

Conditions

Malaria

Treatments

Diagnostic Test: Novel malaria diagnostics & tools

Study type

Observational

Funder types

Other

Identifiers

NCT04558515

MA013

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

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