NCT05514886

Evaluation of Molecular Point-of-care Xpert® Xpress SARS-CoV-2 Detection Implementation in Resource-limited Settings

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,429 (actual)
• Sponsor: National Institute for Medical Research, Tanzania · Other Government
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DEVICE	Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test	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.

Timeline

• Start date: 2022-08-10
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2022-08-25
• Last updated: 2024-09-19

Locations

1 site across 1 country: Tanzania