Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

COVID-19 Point-of-Care Diagnostics that Satisfy Global Target Product Profiles

Version 1 : Received: 24 December 2020 / Approved: 28 December 2020 / Online: 28 December 2020 (11:14:55 CET)

A peer-reviewed article of this Preprint also exists.

Ghaffari, A.; Meurant, R.; Ardakani, A. COVID-19 Point-of-Care Diagnostics That Satisfy Global Target Product Profiles. Diagnostics 2021, 11, 115. Ghaffari, A.; Meurant, R.; Ardakani, A. COVID-19 Point-of-Care Diagnostics That Satisfy Global Target Product Profiles. Diagnostics 2021, 11, 115.

Journal reference: Diagnostics 2021, 11, 115
DOI: 10.3390/diagnostics11010115

Abstract

COVID-19 pandemic will continue to pose a major public health threat until vaccination-mediated herd immunity is achieved. Most projections predict vaccine will reach a large subset of the population late in 2021 or early 2022. In the meantime, countries are exploring options to remove strict lockdown measures and allow for society and the economy to return to normal function. One possibility is to expand on existing COVID-19 testing strategies by including large-scale rapid point of care diagnostic tests (POCTs). Currently, there is significant variability in performance and features of available POCTs, making selection and procurement of appropriate test for specific use case difficult. In this review, we have used the World Health Organization’s (WHO) recently published Target Product Profiles (TPPs) for specific use cases of COVID-19 diagnostic tests to screen for top-performing POCTs on the market. Several top-performing POCTs, based on clinical sensitivity/specificity, the limit of detection, and time to results, that meet WHO TPP criteria for direct detection of SARS-CoV-2 (acute infection), or indirect diagnosis of past infection (host antibodies) are highlighted here.

Subject Areas

COVID-19; point-of-care diagnostic test; target product profile; clinical performance

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