An observational study in COVID-19, sponsored by National Institute for Medical Research, Tanzania. Completed at 1 site in Tanzania. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by National Institute for Medical Research, Tanzania · Observational
This study evaluated the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Project Title: Evaluation of molecular point-of-care Xpert® Xpress SARS-CoV-2 detection implementation in resource limited settings (RIA2020EF-2990) - EXPERT-CoV-2
Clinical Trial Registration: NCT05514886
Principal Investigator: Dr Daniel T. R Minja, NIMR- Tanga Centre, Korogwe Research Station, Tanzania
Collaborating Partners: University of Kinshasa, DR Congo, Research Institute for Health Sciences, Burkina Faso, University of Copenhagen, Denmark, University of Antwerp, Belgium, University of Valencia, Spain
Funding: This project (RIA2020EF-2990) is part of the EDCTP2 programme supported by the European Union.
Date: 17th July 2024
Background: Rapid diagnostic tests of individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are the cornerstone to implementing early case detection and management to control the spread of the deadly virus. RT-PCR is the gold standard for the detection of SARS-CoV-2 but its availability and usability is impeded by fragmented laboratory infrastructure in LMICs and even when available it's only found in reference labs.
The recent development of the Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test, Cepheid Sunnyvale, CA) for SARS-CoV-2 testing in the clinics with results delivery within hours of sample collection has been vital in resolving the turnaround time (TAT). GeneXpert has been widely rolled out within national tuberculosis (TB) and HIV programmes across Africa. However, evaluation of its diagnostic accuracy and the feasibility of its integration into the TB/HIV programme has not been evaluated in resource-constrained settings.
Study objective: This study is envisaged to evaluate the diagnostic accuracy and effectiveness of POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralised healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Methods and Results: This study was conducted in Tanzania, Burkina Faso and DR Congo between 21st July 2021 and February 2024. Data analyses are ongoing and further updates will be made available once the final phylogenetic analyses are completed and ready for publication, details of the clades and variants will also be available.
National Institute for Medical Research, Tanzania is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals age 5 years and above with respiratory symptoms suggestive of SARS-CoV-2 infection
Exclusion Criteria:
POC viral load (VL) assay in improving the availability of SARS-CoV-2 detection for COVID-19 patient management in decentralized healthcare facilities of resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Proportion of patients with SARS-CoV-2 infection
The study will screen patients with respiratory tract infections suggestive of SARS-CoV-2 infection
Time frame: 24 months
Plan to share: Undecided — This will be discussed in the consortium and once consensus has been reached, it will be decided on which information and data will be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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National Institute for Medical Research, Tanzania