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We evaluated the Panbio COVID-19 AG Rapid Test Device (RAD) for the diagnosis of COVID-19 in symptomatic patients attended in primary healthcare centers (n=412). Overall specificity and sensitivity of RAD was 100% and 79.6%, respectively, taking RT-PCR as the reference. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results.

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Objectives: There is limited information on the performance of rapid antigen detection (RAD) tests to identify SARS-CoV-2-infected asymptomatic individuals. In this field study, we evaluated the Panbio COVID-19 Ag Rapid Test Device (Abbott Diagnostics, Jena, Germany) for the purpose. Methods: A total of 634 individuals (355 female; median age, 37 years; range, 9-87) were enrolled. Household (n=338) contacts were tested at a median of 2 days (range, 1-7) after diagnosis of the index case and non-household contacts (n=296) at a median of 6 days (range, 1-7) after exposure. RAD testing was carried out at the point of care. The RT-PCR test used was the TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Massachusetts, USA). Results: In total, 79 individuals (12.4%) tested positive by RT-PCR, of whom 38 (48.1%) yielded positive RAD results. The overall sensitivity and specificity of the RAD test was 48.1% (95% CI: 37.4-58.9) and 100% (95% CI: 99.3-100), respectively. Sensitivity was higher in household (50.8%; 95% CI: 38.9-62.5) than in non-household (35.7%; 95% CI:16.3-61.2%) contacts. Individuals testing positive by RAD test were more likely (P<0.001) to become symptomatic than their negative counterparts. Conclusion: The Panbio test displays low sensitivity in asymptomatic close contacts of COVID-19 patients, particularly in non-household contacts. Nonetheless, establishing the optimal timing for upper respiratory tract collection in this group seems imperative to pinpoint test sensitivity.