Automated Microscopy Evaluation Study

NCT04558515 | Completed

• 1 other identifier: MA013
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• 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

  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

  up to 6 months

Study Arms (2)

Case

Symptomatic patients positive for malaria by PCR

Diagnostic Test: Novel malaria diagnostics & tools

Control

Symptomatic patients negative for malaria by PCR

Diagnostic Test: Novel malaria diagnostics & tools

Interventions

Novel malaria diagnostics & tools DIAGNOSTIC_TEST

Next generation microscopy tools for malaria diagnosis and medical applications

Case; Control

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms suggestive of malaria seeking clinical care in health facilities

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

Study Sites (1)

Institute of Endemic Diseases, Medical Campus

Khartoum, Sudan

Location

Related Publications (1)

• Hamid MMA, Mohamed AO, Mohammed FO, Elaagip A, Mustafa SA, Elfaki T, Jebreel WMA, Albsheer MM, Dittrich S, Owusu EDA, Yerlikaya S. Diagnostic accuracy of an automated microscope solution (miLab) in detecting malaria parasites in symptomatic patients at point-of-care in Sudan: a case-control study. Malar J. 2024 Jun 28;23(1):200. doi: 10.1186/s12936-024-05029-3.

  PMID: 38943203 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 22, 2020
• Study Start: February 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)