Real-world assessment of the clinical performance of COVID-VIRO ALL IN rapid SARS-CoV-2 antigen test

Laura Pighi; Brandon M. Henry; Simone De Nitto; Gianluca Gianfilippi; Gian Luca Salvagno; Giuseppe Lippi

doi:10.1515/dx-2022-0138

Article

Real-world assessment of the clinical performance of COVID-VIRO ALL IN rapid SARS-CoV-2 antigen test

Laura Pighi , Brandon M. Henry , Simone De Nitto , Gianluca Gianfilippi , Gian Luca Salvagno and Giuseppe Lippi

Published/Copyright: January 20, 2023

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From the journal Diagnosis Volume 10 Issue 2

Abstract

Objectives

Since the external validation of severe acute respiratory syndrome coronavirus 2 antigen rapid diagnostic tests (SARS-CoV-2 RDT-Ags) is a necessary requisite before they can be introduced into routine clinical practice, this study reports the results of a real-world assessment of the clinical performance of the new COVID-VIRO ALL IN device.

Methods

The study population consisted in 165 outpatients (median age: 43 years, range: 14–68 years; 66.1% females) who had paired nasal and nasopharyngeal samples collected upon hospital presentation. The samples were concomitantly tested with the AAZ-LMB COVID-VIRO ALL IN SARS-CoV-2 RDT-Ag and with Cepheid Xpert Xpress SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR).

Results

The number of subjects with positive RT-PCR results (i.e., mean Ct value <45) was 116 (70.3%), 109 (66.1%) and 86 (52.1%) with mean Ct values <37 and <30, respectively. In all RT-PCR positive samples, COVID-VIRO ALL IN displayed 78.8% agreement, 0.698 sensitivity, 1.000 specificity, 0.583 negative predictive value (NPV) and 1.000 positive predictive value (PPV) compared to RT-PCR. The median Ct value of samples testing positive with COVID-VIRO ALL IN was significantly lower than those testing negative (22.8 vs. 32.2; p<0.001). In samples with high viral load (i.e., Ct value <30), COVID-VIRO ALL IN displayed 92.1% agreement, 0.895 sensitivity, 0.949 specificity, 0.983 NPV and 0.951 PPV compared to RT-PCR.

Conclusions

Although the diagnostic performance of COVID-VIRO ALL IN do not exactly match those of the manufacturer, its high NPV in high viral load samples would enable fast-track and rapid identification of highly contagious subjects.

Keywords: antigen testing; COVID-19; diagnosis; infection; SARS-CoV-2

Corresponding author: Prof. Giuseppe Lippi, Section of Clinical Biochemistry and School of Medicine, University Hospital of Verona, Piazzale L.A. Scuro, 10 37134 Verona, Italy, Phone: 0039-045-8122970, Fax: 0039-045-8124308, E-mail: giuseppe.lippi@univr.it

Gian Luca Salvagno and Giuseppe Lippi share senior authorship.

Acknowledgments

The authors acknowledge the staff of the Service of Laboratory Medicine and the Medical Direction of the Pederzoli Hospital (Peschiera del Garda, Italy) for support and technical assistance.

Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: The investigation was conducted in accordance with the Declaration of Helsinki, under the terms of relevant local legislation, and was part of broader study protocol cleared by the Ethical Committee of the Provinces of Verona and Rovigo (971CESC; Approved July 25, 2016).

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Received: 2022-12-15

Accepted: 2022-12-23

Published Online: 2023-01-20

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Articles in the same Issue

https://doi.org/10.1515/dx-2022-0138

Keywords for this article

antigen testing; COVID-19; diagnosis; infection; SARS-CoV-2