Comparative evaluation of Panbio and SD Biosensor antigen rapid diagnostic tests for COVID-19 diagnosis.

ABSTRACT

The aim of our study was to evaluate the diagnostic performance of two antigen rapid diagnostic tests (Ag-RDTs) to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We evaluated Panbio and SD-Biosensor Ag-RDTs. We employed 186 polymerase chain reaction (PCR) negative samples to evaluate the specificity and 170 PCR positive samples to assess the sensitivity. We evaluated their sensitivity according to Cycle threshold (C t ) values and days post onset of symptoms (d.p.o.). Tests were compared using the McNemar's test. Agreement was evaluated using the kappa score. Specificity was 100% for Panbio and 97.3% for SD-Biosensor. Sensitivity for samples with C t ≤ 20 was 100% for both assays and for samples with C t = 20-25 was 93.0% (Panbio) and 95.3% (SD-Biosensor) (p = 1.000). Sensitivity decreased for samples wit C t = 25-30 (Panbio 41.3%, SD-Biosensor 52.2%, p = 0.125) and samples with C t ≥ 30 (Panbio 5.0%, SD-Biosensor 17.5%, p = 0.063). Sensitivity within seven d.p.o. was 87.7% for Panbio and 90.4% for SD-Biosensor and notably decreased after seven d.p.o. Agreement with PCR was excellent for high viral load samples (C t ≤ 25) Panbio, 98.9%, kappa = 0.974; SD-Biosensor, 97.4%, kappa = 0.940. Agreement between Ag-RDTs was excellent (94.9%, kappa = 0.882). Panbio and SD-Biosensor Ag-RDTs showed excellent agreement and diagnostic performance results for samples with high viral loads (C t ≤ 25) or samples within seven d.p.o.