1. Performance of point-of care molecular and antigen-based tests for SARS-CoV-2: a living systematic review and meta-analysis
- Author
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Fragkou, P. C., Moschopoulos, C. D., Dimopoulou, D., Ong, D. S. Y., Dimopoulou, K., Nelson, P. P., Schweitzer, V. A., Janocha, H., Karofylakis, E., Papathanasiou, K. A., Tsiordras, S., De Angelis, Giulia, Tholken, C., Sanguinetti, Maurizio, Chung, H. -R., Skevaki, C., De Angelis G. (ORCID:0000-0002-7087-7399), Sanguinetti M. (ORCID:0000-0002-9780-7059), Fragkou, P. C., Moschopoulos, C. D., Dimopoulou, D., Ong, D. S. Y., Dimopoulou, K., Nelson, P. P., Schweitzer, V. A., Janocha, H., Karofylakis, E., Papathanasiou, K. A., Tsiordras, S., De Angelis, Giulia, Tholken, C., Sanguinetti, Maurizio, Chung, H. -R., Skevaki, C., De Angelis G. (ORCID:0000-0002-7087-7399), and Sanguinetti M. (ORCID:0000-0002-9780-7059)
- Abstract
Background: Molecular and antigen point-of-care tests (POCTs) have augmented our ability to rapidly identify and manage SARS-CoV-2 infection. However, their clinical performance varies among individual studies. Objectives: The evaluation of the performance of molecular and antigen-based POCTs in confirmed, suspected, or probable COVID-19 cases compared with that of laboratory-based RT-PCR in real-life settings. Data sources: MEDLINE/PubMed, Scopus, Embase, Web of Science, Cochrane Library, Cochrane COVID-19 study register, and COVID-19 Living Evidence Database from the University of Bern. Study eligibility criteria: Peer-reviewed or preprint observational studies or randomized controlled trials that evaluated any type of commercially available antigen and/or molecular POCTs for SARS-CoV-2, including multiplex PCR panels, approved by the United States Food and Drug Administration, with Emergency Use Authorization, and/or marked with Conformitè Europëenne from European Commission/European Union. Participants: Close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected, or probable COVID-19 infection of any age. Test/s: Molecular and/or antigen-based SARS-CoV-2 POCTs. Reference standard: Laboratory-based SARS-CoV-2 RT-PCR. Assessment of risk of bias: Eligible studies were subjected to quality-control and risk-of-bias assessment using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Methods of data synthesis: Summary sensitivities and specificities with their 95% CIs were estimated using a bivariate model. Subgroup analysis was performed when at least three studies informed the outcome. Results: A total of 123 eligible publications (97 and 26 studies assessing antigen-based and molecular POCTs, respectively) were retrieved from 4674 initial records. The pooled sensitivity and specificity for 13 molecular-based POCTs were 92.8% (95% CI, 88.9–95.4%) and 97.6% (95% CI, 96.6–98.3%), respectively. The sensitivity of antigen-based P
- Published
- 2023