Abstract

Background

Performance of point-of-care tests in different clinical scenarios and on different samples remains undetermined. We comprehensively evaluated the performance of the nasopharyngeal Panbio COVID-19 Ag Rapid Test Device.

Methods

This is a prospective study that includes consecutive patients attending 3 primary care centers (PCCs) and an emergency department. The antigen test was performed at point-of-care in nasopharyngeal and nasal swabs and in saliva. Positive percent agreement (PPA) and negative percent agreement (NPA) were calculated with the reverse-transcription polymerase chain reaction (RT-PCR) assay as reference standard.

Results

Of 913 patients included, 296 (32.3%) were asymptomatic and 690 (75.6%) came from the PCC. Nasopharyngeal swabs were collected from 913 patients, nasal swabs were collected from 659 patients, and saliva was collected from 611 patients. The 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 of 94% 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 a 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%.

Conclusions

The nasopharyngeal Panbio COVID-19 Ag test performed at point-of-care has a good sensitivity in symptomatic patients with Ct <30 and older age. The test was useful to identify asymptomatic patients with lower Ct values.

Details

Title
Nasopharyngeal Panbio COVID-19 Antigen Performed at Point-of-Care Has a High Sensitivity in Symptomatic and Asymptomatic Patients With Higher Risk for Transmission and Older Age
Author
Mar Masiá 1 ; Fernández-González, Marta 2 ; Sánchez, Manuel 3 ; Carvajal, Mar 2 ; García, José Alberto 2 ; Gonzalo-Jiménez, Nieves 4 ; Victoria Ortiz de la Tabla 5 ; Agulló, Vanesa 2 ; Candela, Inmaculada 6 ; Guijarro, Jorge 7 ; Gutiérrez, José Antonio 8 ; de Gregorio, Carlos 3 ; Gutiérrez, Félix 1 

 Infectious Diseases Unit, Hospital General Universitario de Elche, Elche, Alicante, Spain; Clinical Medicine Department, Universidad Miguel Hernández, San Juan de Alicante, Spain 
 Infectious Diseases Unit, Hospital General Universitario de Elche, Elche, Alicante, Spain 
 Department 20th Health Authority, Consellería de Sanitat, Generalitat Valenciana, Elche, Alicante, Spain 
 Microbiology Service, Hospital General Universitario de Elche, Elche, Alicante, Spain 
 Microbiology Service, Hospital Universitario de San Juan, Alicante, Spain 
 Santa Pola Primary Care Center, Alicante, Spain 
 Altabix Primary Care Center, Elche, Alicante, Spain 
 Emergency Department, Hospital General Universitario de Elche, Elche, Alicante, Spain 
Publication year
2021
Publication date
Mar 2021
Publisher
Oxford University Press
e-ISSN
23288957
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3171175978
Copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.