Performance of the Panbio COVID-19 Rapid Antigen Test Device for infection control purposes

Abstract

Objective: We assessed the performance characteristics of the Panbio COVID-19 Rapid Antigen Test Device in field conditions and its potential use as a point-of-care test for isolation and cohorting patients at risk. Methods: We reviewed our laboratory records from January 2021 to May 2021 to identify subjects with a Panbio COVID-19 Rapid Antigen Test Device (index test) and an reverse transcriptase-polymerase chain reaction (RT-PCR) (reference test) test carried out on the same date. Results: In total, 634 subjects met inclusion criteria. Three (0.2%) samples of the index test were not interpretable. A total of 51 (8.08%) subjects had SARS-CoV-2 infection. The index test had sensitivity 78.85% (95% CI: 66.30-88.94%), specificity 91.58% (95% CI 89.02-93.71), and accuracy 90.54% (95% CI 87.99-92.70%). A total of 11 (1.73%) subjects (one asymptomatic, five with respiratory symptoms, and five with pneumonia) had a false-negative result of the index test with median (range) cycle threshold RT-PCR of 25 (21-30), indicating the presence of high viral load in the nasopharyngeal sample. Conclusions: The Panbio COVID-19 Rapid Antigen Test Device cannot replace SARS-CoV-2 RT-PCR for infection control purposes.

Keywords

• Coronavirus infections/*diagnosis. Sensitivity and specificity. COVID-19 testing.