2 research outputs found
Comparative evaluation of Panbio and SD Biosensor antigen rapid diagnostic tests for COVID-19 diagnosis
The aim of our study was to evaluate the diagnostic performance of two antigen
rapid diagnostic tests (AgâRDTs) to diagnose severe acute respiratory syndrome
coronavirus 2 (SARSâCoVâ2) infection. We evaluated Panbio and SDâBiosensor
AgâRDTs. 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 (Ct) 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 SDâBiosensor. Sensitivity for samples with Ct †20 was 100% for both
assays and for samples with Ct = 20â25 was 93.0% (Panbio) and 95.3% (SDâBiosensor)
(p = 1.000). Sensitivity decreased for samples wit Ct = 25â30 (Panbio: 41.3%,
SDâBiosensor: 52.2%, p = 0.125) and samples with Ct â„ 30 (Panbio: 5.0%, SDâBiosensor:
17.5%, p = 0.063). Sensitivity within seven d.p.o. was 87.7% for Panbio and 90.4% for
SDâBiosensor and notably decreased after seven d.p.o. Agreement with PCR was
excellent for high viral load samples (Ct †25): Panbio, 98.9%, kappa = 0.974;
SDâBiosensor, 97.4%, kappa = 0.940. Agreement between AgâRDTs was excellent
(94.9%, kappa = 0.882). Panbio and SDâBiosensor AgâRDTs showed excellent agreement
and diagnostic performance results for samples with high viral loads (Ct †25)
or samples within seven d.p.o
Diagnostic performance of CerTest and Panbio antigen rapid diagnostic tests to diagnose SARS-CoV-2 infection
Objectives Antigen rapid diagnostic tests (Ag-RDT) have been developed as reliable tools to control the SARS-CoV-2 pandemic. The objective of our study was to evaluate the diagnostic performance of two Ag-RDTs. Methods We evaluated CerTest SARS-CoV-2 Ag One Step Card Test and Panbio COVID-19 Ag Rapid Test Device Ag-RDTs. We included 320 nasopharyngeal samples: 150 PCR negative samples to assess the specificity and 170 PCR positive samples to evaluate the sensitivity. We also evaluated their sensitivity according to cycle threshold (Ct) values and the time from the onset of symptoms. Tests were compared using the McNemar?s test and agreement was evaluated using the kappa score (k). Results Both Ag-RDTs showed a specificity of 100 %. Overall sensitivity was 53.5 % for CerTest and 60.0 % for Panbio. For samples with 25, sensitivity was 94.0 % for CerTest and 96.4 % for Panbio (p = 0.500). Regarding samples with Ct>25, sensitivity was 14.0 % for CerTest and 24.4 % for Panbio (p = 0.004). Sensitivity for samples within the first 5 days after the onset of symptoms were 84.8 % for CerTest and 91.3 % for Panbio (p = 0.250) and notably decreased for samples taken after the fifth day. Both Ag-RDTs showed an excellent agreement between them (agreement = 96.7 %, k = 0.920). Agreement with PCR was also excellent for high viral load samples (Ct<25) for CerTest (98.0 %, k = 0.954) and Panbio (98.8 %, k = 0.973). Conclusions CerTest SARS-CoV-2 and Panbio COVID-19 Ag showed excellent performance and agreement results for samples with high viral loads (Ct 25) or samples taken within the first 5 days after the onset of symptoms