Cargando…

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

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 patien...

Descripción completa

Detalles Bibliográficos
Autores principales: Masiá, Mar, Fernández-González, Marta, Sánchez, Manuel, Carvajal, Mar, García, José Alberto, Gonzalo-Jiménez, Nieves, Ortiz de la Tabla, Victoria, Agulló, Vanesa, Candela, Inmaculada, Guijarro, Jorge, Gutiérrez, José Antonio, de Gregorio, Carlos, Gutiérrez, Félix
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928615/
https://www.ncbi.nlm.nih.gov/pubmed/33723512
http://dx.doi.org/10.1093/ofid/ofab059
_version_ 1783659884203474944
author Masiá, Mar
Fernández-González, Marta
Sánchez, Manuel
Carvajal, Mar
García, José Alberto
Gonzalo-Jiménez, Nieves
Ortiz de la Tabla, Victoria
Agulló, Vanesa
Candela, Inmaculada
Guijarro, Jorge
Gutiérrez, José Antonio
de Gregorio, Carlos
Gutiérrez, Félix
author_facet Masiá, Mar
Fernández-González, Marta
Sánchez, Manuel
Carvajal, Mar
García, José Alberto
Gonzalo-Jiménez, Nieves
Ortiz de la Tabla, Victoria
Agulló, Vanesa
Candela, Inmaculada
Guijarro, Jorge
Gutiérrez, José Antonio
de Gregorio, Carlos
Gutiérrez, Félix
author_sort Masiá, Mar
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7928615
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-79286152021-03-04 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 Masiá, Mar Fernández-González, Marta Sánchez, Manuel Carvajal, Mar García, José Alberto Gonzalo-Jiménez, Nieves Ortiz de la Tabla, Victoria Agulló, Vanesa Candela, Inmaculada Guijarro, Jorge Gutiérrez, José Antonio de Gregorio, Carlos Gutiérrez, Félix Open Forum Infect Dis Major Articles 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. Oxford University Press 2021-02-02 /pmc/articles/PMC7928615/ /pubmed/33723512 http://dx.doi.org/10.1093/ofid/ofab059 Text en © The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Major Articles
Masiá, Mar
Fernández-González, Marta
Sánchez, Manuel
Carvajal, Mar
García, José Alberto
Gonzalo-Jiménez, Nieves
Ortiz de la Tabla, Victoria
Agulló, Vanesa
Candela, Inmaculada
Guijarro, Jorge
Gutiérrez, José Antonio
de Gregorio, Carlos
Gutiérrez, Félix
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Major Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7928615/
https://www.ncbi.nlm.nih.gov/pubmed/33723512
http://dx.doi.org/10.1093/ofid/ofab059
work_keys_str_mv AT masiamar nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT fernandezgonzalezmarta nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT sanchezmanuel nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT carvajalmar nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT garciajosealberto nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT gonzalojimeneznieves nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT ortizdelatablavictoria nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT agullovanesa nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT candelainmaculada nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT guijarrojorge nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT gutierrezjoseantonio nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT degregoriocarlos nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage
AT gutierrezfelix nasopharyngealpanbiocovid19antigenperformedatpointofcarehasahighsensitivityinsymptomaticandasymptomaticpatientswithhigherriskfortransmissionandolderage