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Comparative diagnostic performance of rapid antigen detection tests for COVID-19 in a hospital setting.
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.
  • Bruzzone B; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • De Pace V; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • Caligiuri P; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • Ricucci V; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • Guarona G; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy.
  • Pennati BM; Department of Health Sciences, University of Genoa, Genoa, Italy.
  • Boccotti S; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy.
  • Orsi A; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy.
  • Domnich A; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy. Electronic address: alexander.domnich@hsanmartino.it.
  • Da Rin G; Laboratory Medicine, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, 16132 Genoa, Italy.
  • Icardi G; Hygiene Unit, San Martino Policlinico Hospital - IRCCS for Oncology and Neurosciences, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy.
Int J Infect Dis ; 107: 215-218, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1300802
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: J.ijid.2021.04.072

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Humans Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: J.ijid.2021.04.072