Clinical Performance of Rapid Antigen Tests for the Detection of SARS-CoV-2 Infection in the Emergency Department and Community: A Retrospective Study

Background. Rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection have been authorized for emergency use (EUA); however, the performance has not been fully evaluated in clinical contexts. This study aimed to provide evidence regarding the diagnostic performan...

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Bibliographic Details
Published in:The Canadian journal of infectious diseases & medical microbiology 2022-10, Vol.2022, p.1-6
Main Authors: Lin, Pei-Chin, Chiu, Hung-Pin, Cheng, Fang-Yi, Chang, Chih-Chun, Chu, Fang-Yeh
Format: Article
Language:English
Subjects:
Antigen-antibody reactions
Antigens
Body temperature
Chromatography
Comparative analysis
Coronaviruses
COVID-19
Emergencies
Emergency medical care
Emergency medical services
Emergency service
Health aspects
Hospitals
Immunoassay
Infections
Infectious diseases
Laboratories
Oxygen saturation
Patients
Polymerase chain reaction
Real time
Reverse transcription
Sensitivity
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Viral diseases
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Summary:Background. Rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection have been authorized for emergency use (EUA); however, the performance has not been fully evaluated in clinical contexts. This study aimed to provide evidence regarding the diagnostic performance of SARS-CoV-2 rapid antigen tests compared with the real-time reverse transcription-polymerase chain reaction (RT-PCR) test in the emergency department (ED) and community. Methods. Patients who underwent SARS-CoV-2 rapid antigen tests using the VTRUST COVID-19 Antigen Rapid Test (TD-4531) and real-time RT-PCR on the same day in the ED or community from May 24, 2021, to June 24, 2021, were examined. Results. Paired nasopharyngeal swabs were collected from 4022 suspected COVID-19 patients: 800 in the ED and 3222 in the community. Overall, 62 (1.54%) tested positive, 13 tested indeterminate, and 3947 tested negative by real-time RT-PCR. The sensitivity and specificity of the antigen test were 51.61% and 99.44% (overall), 62.50% and 99.61% (ED), and 31.82% and 99.40% (community), respectively. There were 30 false negatives and 22 false positives. Among the false negatives, 16.67% had a cycle threshold (Ct) value of 25. This test can be useful for the rapid identification of infected subjects in an epidemic situation.
ISSN:1712-9532
1918-1493
DOI:10.1155/2022/9447251