Abstract
Objectives: RT-PCR assay is the reference method for diagnosis of COVID-19, but it is also a laborious and time-consuming technic, limiting the availability of testing. 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 Clinitest Rapid COVID-19 Antigen Test (ClinitestRT) (SIEMENS) for SARS-CoV-2 in nasopharyngeal swab specimens.
Methods: This prospective multicenter study was carried out in three Spanish university hospitals including individuals with clinical symptoms or epidemiological criteria for 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 ClinitestRT, as a point-of-care test, and a diagnostic RT-PCR test.
Results: Overall sensitivity and specificity for the ClinitestRT among the 450 patients studied were 93.3% (CI 95%: 89.7-96.8) and 99.2% (CI 95%: 97.2-99.8), respectively. Sensitivity in participants with ≤5 days of the clinical course was 93.6% (CI 95%: 89.2-96.3), and in participants who had a C T < 25 for the RT-PCR test was 98.4% (CI 95%: 94.5-99.6). Agreement between techniques was 96.7% (kappa score: 0.93; CI 95%: 0.90-0.97).
Conclusions: The ClinitestRT provides good clinical performance, with more reliable results for patients with a higher viral load. The results must be interpreted based on the local epidemiological context.
Keywords: COVID-19; Rapid antigen-detection test; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, Rapid antigen-detection test, 【초록키워드】 SARS-CoV-2, Clinical symptoms, reliability, Test, diagnostic, Local, Nasopharyngeal swab, point-of-care, Clinical course, Sensitivity and specificity, Viral load, Patient, Rapid, epidemiological, agreement, multicenter, RT-PCR assay, RT-PCR test, Nasopharyngeal swab specimens, criteria, exposure to, clinical symptom, individual, university hospital, participant, PCR assay, reference method, Siemens, nasopharyngeal sample, Spanish, carried, onset of symptom, can be used, provide, less, determine, faster, time-consuming, antigen-detection, diagnosis of COVID-19, 【제목키워드】 Antigen, multicenter, diagnosis of SARS-CoV-2,