Diagnostic evaluation of Panbio™ antigen rapid diagnostic test for SARS-CoV-2: A systematic review and meta-analysis

Abstract

Introduction: The reverse transcriptase polymerase chain reaction (RT-PCR) is the reference diagnostic method for the confirmation of SARS-CoV-2 infected cases. However, various antigen rapid diagnostic tests (Ag-RDTs) have been developed. The purpose of this meta-analysis study was to assess the diagnostic performance of Panbio™ Ag-RDT (Abbott Point of Care) in identifying the SARS-CoV-2 virus.

Methods: We systematically searched eight databases from March 2020 until March 2023 to look for potentially eligible articles. Diagnostic meta-analysis of Panbio™ Ag-RDT used diverse evaluation indicators, including sensitivity, specificity, Diagnostic Odds Ratio (DOR), and the area under the curve (AUC) value.

Results: Of the 794 articles identified, 49 studies met the inclusion criteria. The pooled estimates of Panbio™ Ag-RDT for the diagnosis of SARS-CoV-2 were 0,65 (95% CI: 0,64-0,66), 0,99 (95% CI: 0,99-1,00), 578,03 (95% CI: 333,37-1002,26) for sensitivity, specificity, and DOR, respectively. Moreover, the summary receiver operating characteristic (SROC) curve revealed an AUC value of 0,942 (95% CI: 0,941-0,943), suggesting an outstanding diagnostic accuracy. Subgroup and meta-regression analyses showed that continent, study period, age, study population and cycle threshold (Ct) values constituted a source of heterogeneity. Furthermore, we demonstrated proof of publication bias for DOR values analyzed using Deek's test (p = 0,001) and funnel plot.

Conclusion: Panbio™ Ag-RDT presented an outstanding diagnostic accuracy in the detection of the SARS-CoV-2 virus in both adults and children with or without symptoms.

Keywords: Accuracy; COVID-19; Panbio™ Ag-RDT; Sensitivity; Specificity.