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Utility of Antigen-Based Rapid Diagnostic Test for Detection of SARS-CoV-2 Virus in Routine Hospital Settings.
- Source :
-
Laboratory medicine [Lab Med] 2021 Nov 02; Vol. 52 (6), pp. e154-e158. - Publication Year :
- 2021
-
Abstract
- Objective: This study aims to evaluate the performance of an antigen-based rapid diagnostic test (RDT) for the detection of the SARS-CoV-2 virus.<br />Methods: A cross-sectional study was conducted on 677 patients. Two nasopharyngeal swabs and 1 oropharyngeal swab were collected from patients. The RDT was performed onsite by a commercially available immune-chromatographic assay on the nasopharyngeal swab. The nasopharyngeal and oropharyngeal swabs were examined for SARS-CoV-2 RNA by real-time reverse-transcription quantitative polymerase chain reaction (RT-qPCR) assay.<br />Results: The overall sensitivity of the SARS-CoV-2 RDT was 34.5% and the specificity was 99.8%. The positive predictive value and negative predictive value of the test were 96.6% and 91.5%, respectively. The detection rate of RDT in RT-qPCR positive results was high (45%) for cycle threshold values <25.<br />Conclusion: The utility of RDT is in diagnosing symptomatic patients and may not be particularly suited as a screening tool for patients with low viral load. The low sensitivity of RDT does not qualify its use as a single test in patients who test negative; RT-qPCR continues to be the gold standard test.<br /> (© American Society for Clinical Pathology, 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Subjects :
- Adolescent
Aged
Aged, 80 and over
Automation, Laboratory
COVID-19 immunology
COVID-19 virology
COVID-19 Serological Testing methods
Cross-Sectional Studies
Female
Humans
Male
Middle Aged
Nasopharynx virology
Oropharynx virology
Reagent Kits, Diagnostic
Reverse Transcriptase Polymerase Chain Reaction methods
SARS-CoV-2 immunology
Sensitivity and Specificity
Viral Load genetics
Antigens, Viral genetics
COVID-19 diagnosis
COVID-19 Serological Testing standards
Chromatography, Affinity methods
RNA, Viral genetics
SARS-CoV-2 genetics
Subjects
Details
- Language :
- English
- ISSN :
- 1943-7730
- Volume :
- 52
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Laboratory medicine
- Publication Type :
- Academic Journal
- Accession number :
- 33928384
- Full Text :
- https://doi.org/10.1093/labmed/lmab033