Abstract
Objectives
The standard RT-PCR assay for coronavirus disease 2019 (COVID-19) is laborious and time-consuming, limiting testing availability. Rapid antigen-detection tests are faster and less expensive; however, the reliability of these tests must be validated before they can be used widely. The objective of this study was to determine the performance of the Panbio™ COVID-19 Ag Rapid Test Device (PanbioRT) (Abbott) in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swab specimens.
Methods
This prospective multicentre study was carried out in ten Spanish university hospitals and included individuals with clinical symptoms or epidemiological criteria of COVID-19. Only individuals with ≤7 days from the onset of symptoms or from exposure to a confirmed case of COVID-19 were included. Two nasopharyngeal samples were taken to perform the PanbioRT as a point-of-care test and a diagnostic RT-PCR test.
Results
Among the 958 patients studied, 325 (90.5%) had true-positive results. The overall sensitivity and specificity for the PanbioRT were 90.5% (95%CI 87.5–93.6) and 98.8% (95%CI 98–99.7), respectively. Sensitivity in participants who had a threshold cycle (CT) < 25 for the RT-PCR test was 99.5% (95%CI 98.4–100), and in participants with ≤5 days of the clinical course it was 91.8% (95%CI 88.8–94.8). Agreement between techniques was 95.7% (κ score 0.90; 95%CI 0.88–0.93).
Conclusions
The PanbioRT performs well clinically, with even more reliable results for patients with a shorter clinical course of the disease or a higher viral load. The results must be interpreted based on the local epidemiological context.
【저자키워드】 COVID-19, SARS-CoV2, pandemic, Antigen diagnosis, Control of cases, Multicentre evaluation, Quick diagnosis, 【초록키워드】 coronavirus disease, SARS-CoV-2, coronavirus, reliability, Test, diagnostic, Local, point-of-care, Clinical course, Sensitivity and specificity, Viral load, Patient, Rapid, multicentre, epidemiological, agreement, threshold, RT-PCR assay, Device, RT-PCR test, Nasopharyngeal swab specimens, criteria, Abbott, acute respiratory syndrome, 95%CI, clinical symptom, individual, university hospital, participant, nasopharyngeal sample, Spanish, objective, Result, carried, clinically, the disease, onset of symptom, can be used, less, determine, faster, time-consuming, antigen-detection, true-positive, 【제목키워드】 Infection, antigen-detection, diagnosis of SARS-CoV-2,