Current best evidence for clinical care (more info)
BACKGROUND: The availability of accurate and rapid diagnostic tools for COVID-19 is essential for tackling the ongoing pandemic. Our study aimed to quantify the performance of available antigen-detecting rapid diagnostic tests (Ag-RDTs) in a real-world hospital setting.
METHODS: In this retrospective analysis, the diagnostic performance of 7 Ag-RDTs was compared with real-time reverse transcription quantitative polymerase chain reaction assay in terms of sensitivity, specificity and expected predictive values.
RESULTS: A total of 321 matched Ag-RDTreal-time reverse transcription quantitative polymerase chain reaction samples were analyzed retrospectively. The overall sensitivity and specificity of the Ag-RDTs was 78.7% and 100%, respectively. However, a wide range of sensitivity estimates by brand (66.0%-93.8%) and cycle threshold (Ct) cut-off values (Ct <25: 96.2%; Ct 30-35: 31.1%) was observed. The optimal Ct cut-off value that maximized sensitivity was 29.
CONCLUSIONS: The routine use of Ag-RDTs may be convenient in moderate-to-high intensity settings when high volumes of specimens are tested every day. However, the diagnostic performance of the commercially available tests may differ substantially.
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Rapid Antigen detection tests for other respiratory viruses, including influenza, have similar accuracy when compared to RT-PCR. This study supports the recommendation to use Rapid Antigen detection tests in high volume, daily surveillance testing settings, such as in schools, colleges, universities, nursing homes & prisons. The goal is to identify asymptomatic or mildly symptomatic people as early as possible to prevent further transmission.