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

National Institute for Medical Research, Tanzania

Status: Not yet enrolling

Conditions: COVID-19

Treatments: Device: Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test

Study type: Observational

Funder types: Other

Identifiers

NCT05514886

EXPERT-CoV-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,600 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 5 years and above presenting with symptoms as indicated in national COVID-19 standard cases definitions or
• Presence of one or more respiratory symptoms (fever (defined as >37.5°C), Persistent coughs, headache, myalgia, sore throat ) or One risk factor for COVID-19, including known contact with a patient with COVID-19, underlying comorbidities, smoking.
• Provision of an informed consent/assent (for minors aged 11-17 years) by themselves or parents/guardians to participate

Exclusion criteria

• Inability or unwillingness to give written informed consent/assent.