Article ; Online: Clinitest rapid COVID-19 antigen test for the diagnosis of SARS-CoV-2 infection: A multicenter evaluation study.
2021 Volume 143, Page(s) 104961
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 ... ...
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 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. |
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MeSH term(s) | Antigens, Viral ; COVID-19 ; Citric Acid ; Copper Sulfate ; Humans ; Prospective Studies ; Reproducibility of Results ; SARS-CoV-2 ; Sensitivity and Specificity ; Sodium Bicarbonate |
Chemical Substances | Antigens, Viral ; Citric Acid (2968PHW8QP) ; Clinitest (63126-89-6) ; Sodium Bicarbonate (8MDF5V39QO) ; Copper Sulfate (LRX7AJ16DT) |
Language | English |
Publishing date | 2021-08-23 |
Publishing country | Netherlands |
Document type | Journal Article ; Multicenter Study |
ZDB-ID | 1446080-4 |
ISSN | 1873-5967 ; 1386-6532 |
ISSN (online) | 1873-5967 |
ISSN | 1386-6532 |
DOI | 10.1016/j.jcv.2021.104961 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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