Roadmap to the Bioanalytical Testing of COVID-19: From Sample Collection to Disease Surveillance

Abstract

The disease caused by SARS-CoV-2, coronavirus disease 2019 (COVID-19), has led to a global pandemic with tremendous mortality, morbidity, and economic loss. The current lack of effective vaccines and treatments places tremendous value on widespread screening, early detection, and contact tracing of COVID-19 for controlling its spread and minimizing the resultant health and societal impact. Bioanalytical diagnostic technologies have played a critical role in the mitigation of the COVID-19 pandemic and will continue to be foundational in the prevention of the subsequent waves of this pandemic along with future infectious disease outbreaks. In this Review, we aim at presenting a roadmap to the bioanalytical testing of COVID-19, with a focus on the performance metrics as well as the limitations of various techniques. The state-of-the-art technologies, mostly limited to centralized laboratories, set the clinical metrics against which the emerging technologies are measured. Technologies for point-of-care and do-it-yourself testing are rapidly emerging, which open the route for testing in the community, at home, and at points-of-entry to widely screen and monitor individuals for enabling normal life despite of an infectious disease pandemic. The combination of different classes of diagnostic technologies (centralized and point-of-care and relying on multiple biomarkers) are needed for effective diagnosis, treatment selection, prognosis, patient monitoring, and epidemiological surveillance in the event of major pandemics such as COVID-19.

Proteomics and Machine Learning Approaches Reveal a Set of Prognostic Markers for COVID-19 Severity With Drug Repurposing Potential

“…The rapid diagnosis of the COVID-19 has been possible due to the increased availability and deployment of RT-PCR assays (Corman et al, 2020), or serological test kits, and scaling-up of testing rates globally (Hosseini et al, 2020). However, the prognosis of the disease remains to be a challenge since the precise pathophysiological pathways that get perturbed during the disease progression remain largely unexplored.…”

Machine learning-based cytokine microarray digital immunoassay analysis

“…However, even with the discoveries of these biomarkers, the medical community still falls behind with adopting the precision medicine approach to treat life-threatening acute illnesses, such as cytokine release syndrome (CRS), acute respiratory distress syndrome (ARDS) in the global outbreak of the coronavirus disease 2019 (COVID-19) ( Chen et al 2020 ; Huang et al 2020 ; Sinha et al 2020 ). Part of the reasons come from the lack of a sensitive molecular profiling tool to quickly guide clinical decisions or interventions with a near-real-time assay turnaround ( Hosseini et al 2020 ; Russell et al 2020 ). Additionally, to monitor the highly heterogeneous and time-pressing illness conditions, high multiplex capacity is equally important as sensitivity and speed for improving diagnosis and prognosis accuracy with rich, comprehensive information on multiple biomarker profiles ( Hay et al 2017 ; Huang et al 2020 ; Sarma et al 2020 ; Teachey et al 2016 ).…”

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“…The only hope now is in the success of the emergencyapproved vaccines [12,13]. The early diagnosis of COVID-19 may help control the spread of the pandemic [14][15][16].…”