Evaluation of molecular point-of-care Xpert® Xpress SARS-CoV-2 detection implementation in resource limited settings (EXPERT-CoV2)

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.

The current diagnostic strategy recommended to identify COVID-19 suspects is based on the detection of viral RNA to SARS–CoV-2 in respiratory tract samples using molecular tests such as SARS–CoV-2 specific real time polymerase chain reaction (RT-PCR). However, in many resources constrained countries, diagnostic facilities and access to RT-PCR is challenging.

Furthermore, such tests are and time consuming and done in centralized laboratories facing shortage of skilled staff, unreliable transportation networks, and inefficient systems for result delivery.

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).

The assay is an automated POC for qualitative detection of SARS-CoV-2 in respiratory tract samples of suspected patients. GeneXpert have been widely rolled out within national tuberculosis (TB) and HIV programmes across the Africa.

However, evaluation of the diagnostic accuracy of the newly introduced Gene Expert molecular POC Xpert® Xpress SARS-CoV-2/Flu/RSV assays and the feasibility of its integration into the TB/HIV programme has not been evaluated in resource-constrained settings.

It is anticipated that the Gene Expert platform and the introduction of SARS-CoV-2 detection will cater for timely detection of COVID-19 cases, reduce case fatalities, facilitate containment and lower the burden at national reference labs.

Furthermore, Cepheid has also come up with a combo four plex assay for SARS-CoV-2 testing and other respiratory viral infections including influenza virus A and B, respiratory syncitial virus (RSV) offers a window of opportunities for application of this technology in resource limited settings. Study objective.

This study aims 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 Africa.

There is also a window of possibility for detecting other respiratory viral infections if a four plex assay cartridges are used.

We will implement genomics surveillance of SARS-CoV-2 and other respiratory viruses to elucidate transmission, evolution, and geographical spread and inform pandemic control efforts and policies makers at local and regional level. Relevance.

The rapid spread of SAR-CoV-2 necessitates an urgent improvement in testing capacity at decentralized health facilities in the region.

The recent advances in in vitro diagnostic (IVD) assays using the Xpert® Xpress SARS-CoV-2/Flu/RSV (Cepheid, Sunnyvale, CA) assay has potential to scale up and improve diagnostics in the region to support patients management and response strategies to curtail the spread of SARS-CoV-2 other newly emerging respiratory viral infections.

Therefore, a quick evaluation and deployment of this tool will contribute toward controlling the transmission of SARS-CoV-2 in the population.