Real-world clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a systematic review of available trials as per April, 4, 2021

Point-of-care assays offer a decentralised and fast solution to the diagnosis of SARS-CoV-2 and provide benefits for patients, healthcare workers, healthcare facilities and other environments. This technology has to potential to prevent outbreaks, enable faster adoption of life-changing measures and improve hospitalar workflow. While reviews regarding the performance of those assays exist, a review focused on the real-life clinical performance and point-of-care feasibility of those platforms was missing. Therefore, the objective of this study is to help end users (clinicians, healthcare providers and organisations) 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. 871 studies were screened in 3 major databases and 51 studies were included, evaluating 20 antigen tests and 10 nucleic-acid amplification platforms. We excluded studies that used processed samples, pre-selected populations, archived samples and laboratory-only evaluations and strongly favored prospective trial designs in our inclusion criteria. We also investigated package inserts, instructions for use, comments on published studies and manufacturers websites in order to assess feasibility of POC placement and additional information of relevance to the end user. Apart from 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 evaluate POC 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 studies. 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 was missing, impairing the ability of individuals, healthcare providers and test providers to make informed decisions on the adoption of such platforms. Objective(s) or question(s) the review addressesThe objective of this study is to help clinicians, healthcare providers and organisations 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 hospitalar environments.