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Evaluation of the Performance of Rapid Diagnostics for SARS-CoV-2 Self-testing in the Hands of Untrained

NCT05605769 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3266

Last updated 2023-10-11

No results posted yet for this study

Summary

The aim of this study is to independently evaluate the usability and performance of rapid assays detecting SARS-CoV-2 antigen(s) and intended for self-testing. For this, the results of the test performed and interpreted by an untrained lay user will be compared to the results obtained by a trained healthcare professional using the same test kit, and, separately, to the current gold standard for testing, RT-PCR detecting SARS-CoV-2 RNA

Conditions

Sponsors & Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Maia Alkhazashvili, MD · Lugar Centre

  • Isaac Ssewanyana, Phd · Uganda National Laboratory Services

  • Mohhamed Majam, Msc · Ezintsha Research Centre

  • Cesar Ugarte, Phd · UPCH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • South Africa
  • Uganda

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05605769 on ClinicalTrials.gov