Automated Microscopy Evaluation Study

Completed

• Conditions: Malaria
• Interventions: Diagnostic Test: Novel malaria diagnostics & tools

• Registration Number: NCT04558515
• Lead Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-22
• Primary Completion: 2021-07-01
• Study Completion: 2021-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Novel malaria diagnostics & tools	Symptomatic patients positive for malaria by PCR
Control	Novel malaria diagnostics & tools	Symptomatic patients negative for malaria by PCR

Primary Outcome Measures

Name	Time	Method
Clinical performance assessment	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	up to 6 months	Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading

Trial Locations

Locations (1)

Institute of Endemic Diseases, Medical Campus; 🇸🇩 Khartoum, Sudan