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

Abstract

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.

Large-Scale SARS-CoV-2 Antigen Testing With Real-World Specimens

“…Ultimately, multiple factors, including the duration of symptoms, previous screening results, and the screening setting, need to be weighed to determine whether a RAT should be employed to preclude molecular-based testing ( 38 ). Regardless, further evidence is needed to confirm RAT sensitivity estimates that are listed in manufacturer IFUs to ensure that the RAT in question performs as indicated in a real-world setting ( 19 ). Allan-Blitz et al recently demonstrated a notably lower sensitivity estimate for one RAT in a large study population than that originally listed in the manufacturer's IFU ( 15 ).…”

“…Recent work shows that performance values (e.g., test sensitivity and specificity) for individual SARS-CoV-2 RATs, reported from real-world studies, can differ when compared to those presented in the manufacturer's instructions for use (IFU) ( 13 – 18 ). Several factors, including study design and experimental bias, can affect RAT sensitivity estimates; ( 18 ) therefore, it is important to monitor their real-world performance ( 19 ). In addition, it is important to supplement registration studies with real-world studies to establish a precise performance profile for RATs over time.…”

Are SARS-CoV-2 self-tests used for their intended purpose? The experience in Belgium.

“…On the one hand, self-testing comes at the cost of loss of accuracy. Several studies have shown that provider-administered RATs are less sensitive than RT-PCR, particularly when the viral load is low [10][11][12][13]. Moreover, studies with point-of-care tests for other infectious diseases already highlighted the importance of trained staff [14][15][16].…”