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 or suspected or probable COVID-19 cases compared to laboratory-based reverse transcription polymerase chain reaction (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 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. PARTICIPANTS: Close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected or probable COVID-19 infection of any age. INDEX TESTS: Molecular and/or antigen-based SARS-CoV-2POCTs. REFERENCE STANDARD: Laboratory-based SARS-CoV-2RT-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 (QUADAS-2) tool. METHODS OF DATA SYNTHESIS: Summary sensitivities and specificities with their 95% confidence intervals (95%CI) were estimated using the bivariate model. Subgroup analysis was performed when at least 3 studies informed the outcome. RESULTS: A total of 123 eligible publications (97 and 26 studies assessing antigen and molecular POCTs, respectively) were retrieved from 4,674 initial records. The pooled sensitivity and specificity for the 13 molecular-based POCTs was 92.8% (95%CI:88.9%-95.4%) and 97.6% (95%CI:96.6%-98.3%), respectively. The sensitivity of antigen-based POCTs pooled from 138 individual evaluations was considerably lower than molecular-based POCTs; the pooled sensitivity and specificity rates were 70.6% (95%CI:67.2%-73.8%) and 98.9% (95%CI:98.5%-99.2%), respectively. CONCLUSIONS: Further studies are needed to evaluate the performance of molecular and antigen POCTs in underrepresented patient subgroups and different respiratory samples.
- 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.
- Tsiodras, S.
- De Angelis, G.
- Thölken, C.
- Sanguinetti, M.
- Chung, H. R.
- Skevaki, C.
Keywords
- Antigen-based test
- Covid-19
- Molecular test
- Nucleic acid amplification test
- Rapid test
- SARS-CoV-2
- point of care test
