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. 2022 Nov 3;29(3):291–301. doi: 10.1016/j.cmi.2022.10.028

Table 1.

Study eligibility and exclusion criteria as well as the main and secondary outcomes of this systematic review

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.