ABSTRACT
COVID-19 self-testing strategy (COVIDST) can rapidly identify symptomatic and asymptomatic SARS-CoV-2-infected individuals and their contacts, potentially reducing transmission. In this living systematic review, we evaluated the evidence for real-world COVIDST performance. Two independent reviewers searched six databases (PubMed, Embase, Web of Science, World Health Organization database, Cochrane COVID-19 registry, Europe PMC) for the period April 1st, 2020, to January 18th, 2023. Data on studies evaluating COVIDST against laboratory-based conventional testing and reported on diagnostic accuracy, feasibility, acceptability, impact, and qualitative outcomes were abstracted. Bivariate random effects meta-analyses of COVIDST accuracy were performed (n=14). Subgroup analyses (by sampling site, symptomatic/asymptomatic infection, supervised/unsupervised strategy, with/without digital supports) were conducted. Data from 70 included studies, conducted across 25 countries with a median sample size of 817 (range: 28-784,707) were pooled. Specificity was high overall, irrespective of subgroups (98.37-99.71%). Highest sensitivities were reported for: a) symptomatic individuals (73.91%, 95%CI: 68.41-78.75%; n=9), b) mid-turbinate nasal samples (77.79%, 95%CI: 56.03-90.59%; n=14), c) supervised strategy (86.67%, 95%CI: 59.64-96.62%; n=13), and d) presence of digital interventions (70.15%, 95%CI: 50.18-84.63%; n=14). Sensitivity was lower in asymptomatic populations (40.18%, 95% CI: 21.52-62.20%; n=4), due to errors in test conduct and absence of supervision or a digital support. We found no difference in COVIDST sensitivity between delta and omicron pre-dominant period. Digital supports increased confidence in COVIDST reporting and interpretation (n=16). Overall acceptability was 91.0-98.7% (n=2) with lower acceptability reported for daily self-testing (39.5-51.1%). Feasibility was 69.0-100.0% (n=5) with lower feasibility (35.9-64.6%) for serial self-testing. COVIDST decreased closures in school, workplace, and social events (n=4). COVIDST is an effective rapid screening strategy for home-, workplace- or school-based screening, for symptomatic persons, and for preventing transmission during outbreaks. This data is useful for updating COVIDST policy. Our review demonstrates that COVIDST has paved the way for the introduction of self-tests, worldwide.
Subject(s)
COVID-19 , Severe Acute Respiratory SyndromeABSTRACT
Introduction: Testing is critical to controlling the COVID-19 pandemic. Antigen-detecting rapid diagnostic tests (Ag-RDTs) that can be used at the point of care have the potential to increase access to COVID 19 testing, particularly in settings with limited laboratory capacity. This systematic review synthesized literature on specific use cases and performance of Ag RDTs for detecting SARS-CoV-2, for the first comprehensive assessment of Ag RDT use in real-world settings. Methods: We searched three databases (PubMed, EMBASE and medRxiv) up to 12 April 2021 for publications on Ag-RDT use for large-scale screening,irrespective of symptoms, and surveillance of COVID-19, excluding studies of only presumptive COVID-19 patients. We tabulated data on the study setting, populations, type of test, diagnostic performance and operational findings. We assessed risk of bias using QUADAS-2 and an adapted tool for prevalence studies. Results: From 4313 citations, 39 studies conducted in asymptomatic and symptomatic adults were included. Study sample sizes varied from 40 to >5 million. Of 39 studies, 37 (94.9%) investigated lateral flow Ag-RDTs and two (5.1%) investigated multiplex sandwich chemiluminescent enzyme immunoassay Ag-RDTs. Six categories of testing (screening/surveillance) initiatives were identified: mass screening (n=13), targeted screening (n=11), healthcare entry testing (n=6), at-home testing (n=4), surveillance (n=4) and prevalence survey (n=1). Across studies, Ag-RDT sensitivity varied from 40% to 100%. Ag-RDTs were noted as convenient, easy-to-use and low cost, with a rapid turnaround time and high user acceptability. Risk of bias was generally low or unclear across the studies. Conclusion: This systematic review demonstrates the use of Ag-RDTs across a wide range of real-world settings for screening and surveillance of COVID-19 in both symptomatic and asymptomatic individuals. Ag-RDTs were overall found to be easy-to-use, low cost and rapid tools, when consideration is given to their implementation and interpretation. The review was funded by FIND, the global alliance for diagnostics.