Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17th of August, 2021

Abstract

AbstractPoint-of-care assays offer a decentralized and fast solution to the diagnosis of SARS-CoV-2, providing benefits for patients, healthcare workers and healthcare facilities. This technology has the potential to prevent outbreaks, enable fast adoption of potentially life-saving measures and improve hospital workflow. While reviews regarding the laboratory performance of those assays exist, a review focused on the real-life clinical performance and true point-of-care feasibility of those platforms is missing. Therefore, the objective of this study is to help clinicians, healthcare providers and organizations to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities, or inside hospitals. 1246 studies were screened in 3 databases and 87 studies were included, evaluating 27 antigen tests and 11 nucleic-acid amplification platforms deemed feasible for true point-of-care placement. We excluded studies that used processed samples, pre-selected populations, archived samples and laboratory-only evaluations and strongly favored prospective trial designs. We also investigated package inserts, instructions for use, comments on published studies and manufacturer’s websites in order to assess feasibility of point-of-care placement and additional information of relevance to the end-user. Apart from performance in the form of sensitivity and specificity, we present information on time to results, hands-on time, kit storage, machine operating conditions and regulatory status. To the best of our knowledge, this is the first review to systematically compare point-of-care test performance in real-life clinical practice. We found the performance of tests in clinical practice to be markedly different from the manufacturers reported performance and laboratory- only evaluations in the majority of scenarios. Our findings may help in the decision-making process related to SARS-CoV-2 test in real-life clinical settings.Rationale for the reviewA review focused on the real-life clinical performance and point-of-care feasibility of SARS-CoV-2 diagnostic platforms is missing, impairing the ability of individuals, healthcare providers and test providers to make informed decisions.Objective(s) or question(s) the review addressesThe objective of this study is to help clinicians, healthcare providers and organizations to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities or in complex healthcare environments.