Author:
Masiá Mar,Fernández-González Marta,Sánchez Manuel,Carvajal Mar,García José Alberto,Gonzalo Nieves,de la Tabla Victoria Ortiz,Agulló Vanesa,Candela Inmaculada,Guijarro Jorge,Gutiérrez José Antonio,de Gregorio Carlos,Gutiérrez Félix
Abstract
ABSTRACTBackgroundPerformance of point-of-care tests in clinical practice remains undetermined. We aimed to evaluate the performance of the nasopharyngeal Panbio COVID-19 antigen Rapid Test Device in real-life conditions in different clinical scenarios.MethodProspective study conducted in three primary care centers (PCC) and an emergency department. The antigen test was performed at point-of-care in nasopharyngeal and nasal swabs, and in saliva. Positive and negative percent agreement (PPA, NPA) were calculated with the RT-PCR assay as reference standard.ResultsOf 913 patients included, 296 (32.3%) were asymptomatic and 690 (75.6%) came from the PCC. Nasopharyngeal swabs were collected from 913, nasal swabs from 659, and saliva from 611 patients. RT-PCR was positive in 196 (21.5%) nasopharyngeal samples (NPS). Overall PPA (95% CI) in NPS was 60.5% (53.3-67.4), and it was lower in nasal swabs (44.7%) and saliva (23.1%). Test performance in NPS was largely dependent on the cycle threshold (Ct) in RT-PCR, with PPA>90% for Ct≤25 and ≥80% for Ct<30. In symptomatic patients, the PPA was 95% for Ct≤25; ≥85% for Ct<30, and 89% for the symptom triad of fever, cough and malaise. Performance was also dependent on age, with PPA of 100% in symptomatic patients >50 years with Ct<25. In asymptomatic patients, the PPA was 86% for Ct<25. In all cases, NPA was 100%.ConclusionThe nasopharyngeal Panbio COVID-19 antigen test performed at point-of-care is highly sensitive in symptomatic patients, particularly with Ct<30 and older age. The test was useful to identify asymptomatic patients with lower Ct values and therefore with contagious risk.Key pointsThe nasopharyngeal Panbio-COVID-19 antigen test performed in real-life conditions at point-of-care is highly sensitive in symptomatic patients, particularly with Ct<30 and older age. The test is useful to identify asymptomatic patients with lower Ct values and therefore with contagious risk.
Publisher
Cold Spring Harbor Laboratory
Cited by
9 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献