Panbio™ rapid antigen test for SARS-CoV-2 has acceptable accuracy in symptomatic patients in primary health care. Issue 3 (March 2021)

• Record Type: Journal Article
• Authors: Bulilete, Oana; Lorente, Patricia; Leiva, Alfonso; Carandell, Eugenia; Oliver, Antonio; Rojo, Estrella; Pericas, Pau; Llobera, Joan
• Is Part Of: Journal of infection. Volume 82:Issue 3(2021)
• Page Start: 391
• Page End: 398
• Publication Date: 2021-03
• Subjects: COVID-19 -- Rapid antigen test -- Sar-CoV-2 -- Primary care; Infection -- Periodicals; Bacterial Infections -- Periodicals; Communicable Diseases -- Periodicals; Electronic journals; 616.905
• DOI: 10.1016/j.jinf.2021.02.014
• Languages: English
• ISSNs: 0163-4453

Abstract

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. 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