TY - JOUR
T1 - On-field evaluation of a ultra-rapid fluorescence immunoassay as a frontline test for SARS-CoV-2 diagnostic
AU - Orsi, Andrea
AU - Pennati, Beatrice Marina
AU - Bruzzone, Bianca
AU - Ricucci, Valentina
AU - Ferone, Diego
AU - Barbera, Paolo
AU - Arboscello, Eleonora
AU - Dentone, Chiara
AU - Icardi, Giancarlo
N1 - Funding Information:
We thank all staff of the Hygiene Unit, Regional Reference Laboratory for COVID-19 diagnostic, for the technical assistance offered for the study conduction. We special thank Simona Boccotti, Patrizia Caligiuri, Rita Cerruti, Valerio Chessa, Vanessa De Pace, Gaetano De Rosa, Monica Ferraris, Barbara Galano, Giulia Guarona, Nicola Nigro, Rexhina Qosja, Nadia Randazzo, Matteo Theimer and Serena Varesano for their precious and indispensable work during the current SARS-CoV-2 pandemic.
Publisher Copyright:
© 2021
PY - 2021/9
Y1 - 2021/9
N2 - Background: Viral RNA amplification by real-time RT-PCR still represents the gold standard for the detection of SARS-CoV-2, but the development of rapid, reliable and easy-to-perform diagnostic methods is crucial for public health, because of the need of shortening the time of result-reporting with a cost-efficient approach. Objectives: The aim of our research was to assess the performance of FREND™ COVID-19 Ag assay (NanoEntek, South Korea) as a ultra-rapid frontline test for SARS-CoV-2 identification, in comparison with RT-PCR and another COVID-19 antigen fluorescence immunoassay (FIA). Study design: The qualitative FIA FREND™ test, designed to detect within 3 min the Nucleocapsid protein of SARS-CoV-2, was evaluated using nasopharyngeal swabs in Universal Transport Medium (UTM™, Copan Diagnostics Inc, US) from suspected COVID-19 cases who accessed the Emergency Room of the Ospedale Policlinico San Martino, Genoa, Liguria, Northwest Italy. Diagnostic accuracy was determined in comparison with SARS-CoV-2 RT-PCR and STANDARD F™ COVID-19 Ag FIA test (SD BIOSENSOR Inc., Republic of Korea). Results: In November 2020, 110 nasopharyngeal samples were collected consecutively; 60 resulted RT-PCR positive. With respect to RT-PCR results, sensitivity and specificity of FREND™ COVID-19 Ag test were 93.3 % (95 % CI: 83.8−98.2) and 100 % (95 % CI: 92.9−100), respectively. FREND™and STANDARD F™ COVID-19 Ag FIA assays showed a concordance of 96.4 % (Cohen's k = 0.93, 95 % CI: 0.86−0.99). Conclusions: FREND™ FIA test showed high sensitivity and specificity in nasopharyngeal swabs. The assay has the potential to become an important tool for an ultra-rapid identification of SARS-CoV-2 infection, particularly in situations with limited access to molecular diagnostics.
AB - Background: Viral RNA amplification by real-time RT-PCR still represents the gold standard for the detection of SARS-CoV-2, but the development of rapid, reliable and easy-to-perform diagnostic methods is crucial for public health, because of the need of shortening the time of result-reporting with a cost-efficient approach. Objectives: The aim of our research was to assess the performance of FREND™ COVID-19 Ag assay (NanoEntek, South Korea) as a ultra-rapid frontline test for SARS-CoV-2 identification, in comparison with RT-PCR and another COVID-19 antigen fluorescence immunoassay (FIA). Study design: The qualitative FIA FREND™ test, designed to detect within 3 min the Nucleocapsid protein of SARS-CoV-2, was evaluated using nasopharyngeal swabs in Universal Transport Medium (UTM™, Copan Diagnostics Inc, US) from suspected COVID-19 cases who accessed the Emergency Room of the Ospedale Policlinico San Martino, Genoa, Liguria, Northwest Italy. Diagnostic accuracy was determined in comparison with SARS-CoV-2 RT-PCR and STANDARD F™ COVID-19 Ag FIA test (SD BIOSENSOR Inc., Republic of Korea). Results: In November 2020, 110 nasopharyngeal samples were collected consecutively; 60 resulted RT-PCR positive. With respect to RT-PCR results, sensitivity and specificity of FREND™ COVID-19 Ag test were 93.3 % (95 % CI: 83.8−98.2) and 100 % (95 % CI: 92.9−100), respectively. FREND™and STANDARD F™ COVID-19 Ag FIA assays showed a concordance of 96.4 % (Cohen's k = 0.93, 95 % CI: 0.86−0.99). Conclusions: FREND™ FIA test showed high sensitivity and specificity in nasopharyngeal swabs. The assay has the potential to become an important tool for an ultra-rapid identification of SARS-CoV-2 infection, particularly in situations with limited access to molecular diagnostics.
KW - COVID-19 identification
KW - Fluorescence immunoassay (FIA)
KW - Rapid antigen diagnostic test
KW - SARS-CoV-2 infection
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U2 - 10.1016/j.jviromet.2021.114201
DO - 10.1016/j.jviromet.2021.114201
M3 - Article
C2 - 34058287
AN - SCOPUS:85107695450
VL - 295
JO - Journal of Virological Methods
JF - Journal of Virological Methods
SN - 0166-0934
M1 - 114201
ER -