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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.
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Details
1 Infectious Diseases Unit, Hospital General Universitario de Elche, Elche, Alicante, Spain; Clinical Medicine Department, Universidad Miguel Hernández, San Juan de Alicante, Spain
2 Infectious Diseases Unit, Hospital General Universitario de Elche, Elche, Alicante, Spain
3 Department 20th Health Authority, Consellería de Sanitat, Generalitat Valenciana, Elche, Alicante, Spain
4 Microbiology Service, Hospital General Universitario de Elche, Elche, Alicante, Spain
5 Microbiology Service, Hospital Universitario de San Juan, Alicante, Spain
6 Santa Pola Primary Care Center, Alicante, Spain
7 Altabix Primary Care Center, Elche, Alicante, Spain
8 Emergency Department, Hospital General Universitario de Elche, Elche, Alicante, Spain





