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

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.