COVID-19 Impact on Diagnostic Innovations: Emerging Trends and Implications.

James Woltmann,Kim Dangova,Lucy Barrass,Harsimran Sarpal,Anne O Oyewole,Catherine Richmond,Emily G Robertson,Dawn Craig,Hannah O’Keefe

doi:10.3390/diagnostics11020182

Abstract

Diagnostic testing remains the backbone of the coronavirus disease 2019 (COVID-19) response, supporting containment efforts to mitigate the outbreak. The severity of this crisis and increasing capacity issues associated with polymerase chain reaction (PCR)-based testing, accelerated the development of diagnostic solutions to meet demands for mass testing. The National Institute for Health Research (NIHR) Innovation Observatory is the national horizon scanning organization in England. Since March, the Innovation Observatory has applied advanced horizon scanning methodologies and tools to compile a diagnostic landscape, based upon data captured for molecular (MDx) and immunological (IDx) based diagnostics (commercialized/in development), for the diagnosis of SARS-CoV-2. In total we identified and tracked 1608 diagnostics, produced by 1045 developers across 54 countries. Our dataset shows the speed and scale in which diagnostics were produced and provides insights into key periods of development and shifts in trends between MDx and IDx solutions as the pandemic progressed. Stakeholders worldwide required timely and detailed intelligence to respond to major challenges, including testing capacity and regulatory issues. Our intelligence assisted UK stakeholders with assessing priorities and mitigation options throughout the pandemic. Here we present the global evolution of diagnostic innovations devised to meet changing needs, their regulation and trends across geographical regions, providing invaluable insights into the complexity of the COVID-19 phenomena.

Highlights

The current coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents an unprecedented global challenge [1,2] that has reshaped activities across the diagnostic innovation landscape [3]
SARS-CoV-2 is a respiratory virus, in vitro diagnostic (IVDs) medical devices sit at the heart of SARS-CoV-2 diagnosis and decisions concerning clinical management [3,4,5,6,7]
The growing prevalence of infectious diseases is a major factor driving the growth of the global IVDs market for infectious disease

Summary

Introduction

The current coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presents an unprecedented global challenge [1,2] that has reshaped activities across the diagnostic innovation landscape [3]. Swabs may be taken by the individual at home, but more frequently are taken by professionals, helping to ensure that a thorough sampling technique is used [10]. This increases the likelihood munological tests have been designed to detect the presence of antibodies (IgG/IgM)

Results

Discussion

Conclusion