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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Gene Expert molecular Point-of-Care (POC) (Xpert® Xpress SARS-CoV-2/Flu/RSV test

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 3600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals age 5 years and above with respiratory symptoms suggestive of SARS-CoV-2 infection

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with SARS-CoV-2 infection	The study will screen patients with respiratory tract infections suggestive of SARS-CoV-2 infection	24 months

Collaborators and Investigators

• Sponsor: National Institute for Medical Research, Tanzania
• Collaborators: University of Kinshasa (UNIKIN), Congo, The Democratic Republic of the ( Prof Vivi Maketa); Research Institute for Health Sciences - Burkina Faso, Burkina Faso (Dr Marc Christian Tahita); Universiteit Antwerpen, Belgium (ProfJean-Pierre Van geertruyden); Københavns Universitet (UCPH), Denmark (Prof Michael Alifrangis); Universidad de Valencia, Spain (Prof Fernando Gonzalez-Candelas)

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2
• Other Study ID Numbers: EXPERT-CoV-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No