Comparative diagnostic performance of rapid antigen detection tests for COVID-19 in a hospital setting. (June 2021)

• Record Type: Journal Article
• Authors: Bruzzone, Bianca; De Pace, Vanessa; Caligiuri, Patrizia; Ricucci, Valentina; Guarona, Giulia; Pennati, Beatrice M.; Boccotti, Simona; Orsi, Andrea; Domnich, Alexander; Da Rin, Giorgio; Icardi, Giancarlo
• Is Part Of: International journal of infectious diseases. Volume 107(2021)
• Page Start: 215
• Page End: 218
• Publication Date: 2021-06
• Subjects: COVID-19 -- SARS-CoV-2 -- Rapid antigen detection test -- Italy; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2021.04.072
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: Not all available rapid SARS-CoV-2 antigen tests have a sensitivity of ≥80/90%. Sensitivity of rapid SARS-CoV-2 antigen tests is primarily driven by viral load. Antigen test optimal sensitivity is at reverse transcription PCR cycle threshold ≤29. Highly specific rapid tests are useful for screening in high incidence settings. Abstract: 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.