An observational study in Malaria, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Completed at 1 site in Sudan. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 190 is below the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptoms suggestive of malaria seeking clinical care in health facilities
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Symptomatic patients positive for malaria by PCR
Diagnostic Test: Novel malaria diagnostics & tools
Symptomatic patients negative for malaria by PCR
Diagnostic Test: Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications
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
Time frame: 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
Time frame: up to 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland