Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05514886 |
| Other study ID # |
EXPERT-CoV-2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
August 30, 2024 |
Study information
| Verified date |
August 2022 |
| Source |
National Institute for Medical Research, Tanzania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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 decentralized healthcare facilities of resource-constrained settings in
Tanzania, DR Congo and Burkina Faso.
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
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, Univesity of Antwerp, Belgium,
University of valencia, Spain
Background. Rapid diagnostic tests of individuals infected with severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) are the cornerstone to implement early case detection and
management to control the spread of the deadly virus. RT-PCR is the gold standard for
detection of SARS-CoV-2 but its availability and userability is impeded by fragmented
laboratory infrastructure in LMICs and even when available it's only found in reference labs.
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 have been widely rolled out within national tuberculosis (TB) and HIV
programmes across the 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 decentralized healthcare facilities of
resource-constrained settings in Tanzania, DR Congo and Burkina Faso.
Relevance. The rapid spread of SAR-CoV-2 necessitates an urgent improvement in testing
capacity at decentralized health facilities in the region. Therefore, a quick evaluation and
deployment of this tool will contribute toward controlling the transmission of SARS-CoV-2 in
the population.
This project (RIA2020EF-2990) is part of the EDCTP2 programme supported by the European
Union.
