AutoMic: Automated Microscopy Evaluation Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Case Symptomatic patients positive for malaria by PCR |
Diagnostic Test: Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications
|
| Control Symptomatic patients negative for malaria by PCR |
Diagnostic Test: Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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)
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Willing to provide finger prick blood sample at enrollment
Exclusion Criteria:
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Foundation for Innovative New Diagnostics, Switzerland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA013