Current best evidence for clinical care (more info)
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% (? 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.
|Discipline / Specialty Area||Score|
|Pediatric Emergency Medicine||
|Pediatric Hospital Medicine||
With rapid PCR tests now widely available, this is not particularly game changing, despite the relatively high accuracy compared to PCR.
Although relevant to the specialty, my enthusiasm is diminished because this is a saturated topic and the accuracy of the criterion standard is uncertain.
As an infectious disease specialist, I believe that learning the etiology of an infectious process is essential for the care and the prevention of the disease. This study provides important information about a point of care diagnostics with very encouraging results.
Given the large number of comparable studies, we should focus on systematic reviews rather than single studies.
Methodology was sound. Nicely written.
This is an interesting reliability study on the usefulness of a COVID-19 diagnostic rapid test. The strength is its prospective and multi center design; although, every center used different techniques as a gold standard. The good performance of the evaluated test could help in clinical and community decision making.