Table 1.
Eligibility criteria | Exclusion criteria | Outcomes |
---|---|---|
(1) Studies reported data on the outcomes of interest (2) Studies included close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected or probable COVID-19 infection of any age (3) Studies that evaluated any type of FDA approved and/or with EUA and/or CE-marked from EC/EU commercially available antigen and/or molecular POCTs for SARS-CoV-2, including multiplex PCR panels (4) The index and reference standard tests were performed in any type of respiratory samples (5) Both peer-reviewed studies and preprints were included in the analysis |
(1) Studies utilizing only serology tests or non-respiratory samples (2) Studies reporting interventions not aligned with our pre-defined inclusion criteria, including tests not fulfilling the definition of POCT, or using in-house or non-commercial assays or commercial non-FDA approved or with non-EUA or CE-marked index test (3) Studies using as a reference standard a non-laboratory-based RT-PCR (4) Case reports, case series, book chapters, conference abstracts (5) Studies with non-available full text (6) Analytical accuracy studies (7) Studies with non-extractable data for individual index tests (8) Studies with only sensitivity data |
(1) Evaluation of the performance of molecular-based and antigen-based POCTs in confirmed or suspected or probable COVID-19 patients compared to laboratory-based RT-PCR (2) Evaluation of the performance of molecular-based and antigen-based POCTs in asymptomatic COVID-19 patients or close contacts compared to laboratory-based RT-PCR (3) Evaluation of the performance of molecular-based POCTs in COVID-19 patients compared to antigen-based POCTs (4) The measures of effect were sensitivity and specificity, positive percent agreement and negative percent agreement (5) Subgroup analyses by stratifying our data according to: a. the age of participants (paediatric, adult and mixed population) b. the Ct value of the reference test (Ct<35, Ct<30, Ct<25 and Ct<20) c. the days since the onset of symptoms (≤7 and >7 days of symptoms) d. the way of sample acquisition (self-sampling or self-testing versus testing or sampling by a health professional / trained personnel) e. the different types of biological samples (nasal, nasopharyngeal, oropharyngeal, saliva and combination of them) |
CE, Conformitè Europëenne; Ct, cycle threshold; EC, European Commission; EU, European Union; EUA, Emergency Use Authorization; FDA, United States Food and Drug Administration; POCT, point-of-care test.