Systematic Approach to Address Early Pandemic's Diagnostic Unmet Needs

Abstract

During the first few months of the global Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic, the medical research community had to expeditiously develop, select, and deploy novel diagnostic methods and tools to address the numerous testing challenges presented by the novel virus. Integrating a systematic approach to diagnostic selection with a rapid validation protocol in a clinical setting can shorten the timeline to bring new technologies to practice. In response to the urgent need to provide tools for identifying SARS-CoV-2-positive individuals, we developed a framework for assessing technologies against a set of prioritized performance metrics to guide device selection. We also developed and proposed clinical validation frameworks for the rapid screening of new technologies. The rubric described here represents a versatile approach that can be extended to future technology assessments and can be implemented in preparation for future emerging pathogens.

Visible label-free detection of bacterial DNA using flocculation of sterically stabilised cationic latexes

“…There remains an unmet need for a rapid diagnostic device for quick detection and identification of bacteria and other pathogens. [1][2][3][4] Infectious diseases are often illnesses which can spread quickly and possibly lead to epidemics. 5 It is critical to quickly diagnose initial infections and prevent further spread by diagnosing these infections in vitro.…”

Rapid quantitation of SARS-CoV-2 antibodies in clinical samples with an electrochemical sensor

“…Proper packaging and shipment of DBS samples from home directly to a clinical laboratory for testing makes it a nonregulated material ( Control and C.f.D., 2017 ; Zava and Zava, 2021 ). Thus, there is high demand for rapid and cost-effective detection approaches to monitor levels of different SARS-CoV-2 antibodies in order to assess patient responses to infections and vaccines in a timely manner ( Cabrera et al, 2022 ; Kumar et al, 2022 ; Rahman, 2022 ). These biosensors with high sensitivity and specificity may be used either in low-resource settings or clinical laboratories in combination with use of DBS sampling.…”