Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres.
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.
['Albert|Eliseo|E|', 'Torres|Ignacio|I|', 'Bueno|Felipe|F|', 'Huntley|Dixie|D|', 'Molla|Estefanía|E|', 'Fernández-Fuentes|Miguel Ángel|MÁ|', 'Martínez|Mireia|M|', 'Poujois|Sandrine|S|', 'Forqué|Lorena|L|', 'Valdivia|Arantxa|A|', 'Solano de la Asunción|Carlos|C|', 'Ferrer|Josep|J|', 'Colomina|Javier|J|', 'Navarro|David|D|']
D000293:Adolescent D000328:Adult D000368:Aged D000369:Aged, 80 and over D000554:Ambulatory Care Facilities D000956:Antigens, Viral D000086382:COVID-19 D000087123:COVID-19 Nucleic Acid Testing D000087124:COVID-19 Serological Testing D002648:Child D002675:Child, Preschool D042241:Early Diagnosis D005260:Female D006801:Humans D007118:Immunoassay D007223:Infant D008297:Male D008875:Middle Aged D009305:Nasopharynx D000067716:Point-of-Care Testing D011933:Reagent Kits, Diagnostic D000086402:SARS-CoV-2 D012680:Sensitivity and Specificity D055815:Young Adult
COVID-19 Primary healthcare centre SARS-CoV-2 Early diagnosis Rapid antigen detection test (RAD)