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

• Published in: The Journal of infection 2021-03, Vol.82 (3), p.391-398
• Main Authors: Bulilete, Oana, Lorente, Patricia, Leiva, Alfonso, Carandell, Eugenia, Oliver, Antonio, Rojo, Estrella, Pericas, Pau, Llobera, Joan
• Format: Article
• Language: English
• Subjects: Adult; COVID-19; Female; Humans; Male; Middle Aged; Primary care; Primary Health Care; Rapid antigen test; Sar-CoV-2; SARS-CoV-2; Sensitivity and Specificity; Spain
• ISSN: 0163-4453; 1532-2742
• DOI: 10.1016/j.jinf.2021.02.014

•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. 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. 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. 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. 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. None