1. Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres.
- Author
-
Albert E, Torres I, Bueno F, Huntley D, Molla E, Fernández-Fuentes MÁ, Martínez M, Poujois S, Forqué L, Valdivia A, Solano de la Asunción C, Ferrer J, Colomina J, and Navarro D
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Ambulatory Care Facilities, Antigens, Viral analysis, COVID-19 Nucleic Acid Testing, Child, Child, Preschool, Early Diagnosis, Female, Humans, Immunoassay, Infant, Male, Middle Aged, Nasopharynx virology, Reagent Kits, Diagnostic, SARS-CoV-2 genetics, SARS-CoV-2 immunology, Sensitivity and Specificity, Young Adult, COVID-19 diagnosis, COVID-19 Serological Testing methods, Point-of-Care Testing, SARS-CoV-2 isolation & purification
- Abstract
Objectives: To our knowledge no previous study has assessed the performance of a rapid antigen diagnostic immunoassay (RAD) conducted at the point of care (POC). We evaluated the Panbio™ COVID-19 Ag Rapid Test Device for diagnosis of coronavirus 2019 disease (COVID-19) in symptomatic patients (n = 412) attending primary healthcare centres., Methods: RAD was performed immediately after sampling following the manufacturer's instructions (reading at 15 min). RT-PCRs were carried out within 24 h of specimen collection. Samples displaying discordant results were processed for culture in Vero E6 cells. Presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in cell cultures was confirmed by RT-PCR., Results: Out of 412 patients, 43 (10.4%) tested positive by RT-PCR and RAD, and 358 (86.9%) tested negative by both methods; discordant results (RT-PCR+/RAD-) were obtained in 11 patients (2.7%). Overall specificity and sensitivity of rapid antigen detection (RAD) was 100% (95%CI 98.7-100%) and 79.6% (95%CI 67.0-88.8%), respectively, taking RT-PCR as the reference. Overall RAD negative predictive value for an estimated prevalence of 5% and 10% was 99% (95%CI 97.4-99.6%) and 97.9% (95%CI 95.9-98.9), respectively. SARS-CoV-2 could not be cultured from specimens yielding RT-PCR+/RAD- results (n = 11)., Conclusion: The Panbio™ COVID-19 Ag Rapid Test Device performed well as a POC test for early diagnosis of COVID-19 in primary healthcare centres. More crucially, the data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious., (Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF