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Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care - 18/03/21

Doi : 10.1016/j.jinf.2021.02.014 
Oana Bulilete a, b , Patricia Lorente a, c , Alfonso Leiva a, b, 1, , Eugenia Carandell b, d , Antonio Oliver b, e , Estrella Rojo b, e , Pau Pericas a , Joan Llobera a, b
on behalf of

COVID-19 Primary Care Research Group

a Primary Health Care Research Unit, Balearic Public Health Service (Ib-Salut), Escola Graduada n9, 07002 Palma, Illes Balears, Spain 
b Balearic Islands Health Research Institute (IdISBa), Carretera de Valldemossa, 79, 07120 Palma, Illes Balears, Spain 
c Santa Ponça Primary Health Care Center, Balearic Public Health Service (Ib-Salut), Carrer del Riu Síl, 25, 07180 Santa Ponça, Illes Balears, Spain 
d Directorate of General Health Service, Balearic Public Health Service (Ib-Salut), Reina Esclaramunda n9, 07005 Palma, Illes Balears, Spain 
e Microbiology Service, Son Espases University Hospital, Balearic Public Health Service (Ib-Salut), Carretera de Valldemossa, 79, 07120 Palma, Illes Balears, Spain 

Corresponding author.

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Highligths

Most of patients with mild symptoms (up to 75%) and close contacts are visited and followed-up in primary health care centers or test sites.
The present study is the largest evaluation of the Panbio Ag-RDT in samples from symptomatic and asymptomatic patients in real-world context.
We found an overall sensitivity of the Panbio™ rapid antigen test of 71.4% (95% CI: 63.1%, 78.7% and a specificity of 99.8% (95% CI: 99.4%, 99.9%)
Our results support the use of the Ag-RDT for symptomatic patients within 5 days since the onset of the symptoms in PHC setting and test sites.

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Summary

Objectives

We aimed to evaluate the accuracy of the Panbio™ Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard.

Methods

The study was conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio™ rapid antigen test kit for SARS-CoV-2. The sensitivity and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group.

Findings

A total of 1369 participants were included; mean age 42.5 ± 14.9 years and 54.3% women. The overall prevalence was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms. The overall sensitivity was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity was higher in symptomatic patients, in those arriving within 5 days since symptom onset and in those with high viral load.

Interpretation

Ag-RDT had relatively good performance characteristics in suspected symptomatic patients within five days since the onset of symptoms. However, our data do not support the sole use of Panbio™ Ag-RDT in asymptomatic individuals.

Funding

None

Le texte complet de cet article est disponible en PDF.

Keywords : COVID-19, Rapid antigen test, Sar-CoV-2, Primary care


Plan


 COVID-19 Primary Care Research Group members (alphabetical order)
Layla Aoukhiyad – pharmacist, Servei de Salut de les Illes Balears; email: layla.aoukhiyad@ibsalut.es
Ricardo Arcay – medical microbiologist resident, Son Espases University Hospital Microbiology Unit; email: ricardo.arcay@ssib.es
Javier Arranz – general practitioner, Escola Graduada Primary Care Health Center; email: jarranz@ibsalut.caib.es
Irene Barrionuevo – nurse, Son Espases University Hospital Emergency Unit; email: irenem.barrionuevo@ssib.es
Bernardino Comas – general practitioner, Son Espases University Hospital Emergency Unit; email: bernardino.comas@ssib.es
Sara Contreras – biologist, Primary Health Care Research Unit; email: scontreras3@ibsalut.caib.es
María Fernandez-Billon – medical microbiologist resident, Son Espases University Hospital Microbiology Unit; email: maria.fernandez-billon@ssib.es
J. Luis Ferrer – nurse, Santa Ponça Primary Health Care Center; email: jlferrer@ibsalut.caib.es
Pablo Fraile – medical microbiologist resident, Son Espases University Hospital Microbiology Unit; email: pablo.fraile@ssib.es
Marina García – general practitioner, Inca Primary Care Health Center; email: marinagarcia@ibsalut.caib.es
Carla Iglesias – medical microbiologist resident, Son Espases University Hospital Microbiology Unit; email: carla.iglesias@ssib.es
Miquel Llobera – nurse, Santa Ponça Primary Health Care Center; email: mllobera@ibsalut.caib.es
M. Consolación Méndez – director of nursing, Mallorca Primary Health Care Directorate; email: mmendez@ibsalut.caib.es
Susana Munuera – general practitioner, Servei de Salut de les Isles Balears; email: susana.munuera@ibsalut.es
Victoria Pascual – nurse, COVID Express Testing Center; email: avpascual@ibsalut.caib.es
Carlos Raduan – general practitioner medical director, Mallorca Primary Health Care Directorate; email: craduan@ibsalut.caib.es
Ana Requena – nurse, Coll d'en Rabassa Primary Care Health Center; email: arequena2@ibsalut.caib.es
Antonia Roca – general practitioner medical director, Mallorca Primary Health Care Directorate; email: aroca@ibsalut.caib.es
Pedro Rull – general practitioner, Son Espases University Hospital Emergency Unit; email: pere.rull@ssib.es
Silvia Vallcaneras – nurse, Alcudia Primary Care Health Center; email: svallcaneras@ibsalut.caib.es
Verónica Vega – nurse, COVID Express Testing Center. email: vvega@ibsalut.caib.es


© 2021  Publié par Elsevier Masson SAS.
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Vol 82 - N° 3

P. 391-398 - mars 2021 Retour au numéro
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