Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults

To carry out effective and quick identification of SARS-CoV-2 from nasopharyngeal swabs and contain outbreaks, reliable and rapid tools are needed. Herein, we compared a rapid antigen test based on active microfluidic technology to an RT-qPCR assay in pediatric and young adult patients admitted to t...

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Main Authors: Christian Leli, Lidia Ferrara, Paolo Bottino, Cristina Bara, Iacopo Megna, Serena Penpa, Enrico Felici, Antonio Maconi, Andrea Rocchetti
Format: Article
Language:English
Published: MDPI AG 2023-12-01
Series:Viruses
Subjects:
Online Access:https://www.mdpi.com/1999-4915/16/1/41
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author Christian Leli
Lidia Ferrara
Paolo Bottino
Cristina Bara
Iacopo Megna
Serena Penpa
Enrico Felici
Antonio Maconi
Andrea Rocchetti
author_facet Christian Leli
Lidia Ferrara
Paolo Bottino
Cristina Bara
Iacopo Megna
Serena Penpa
Enrico Felici
Antonio Maconi
Andrea Rocchetti
author_sort Christian Leli
collection DOAJ
description To carry out effective and quick identification of SARS-CoV-2 from nasopharyngeal swabs and contain outbreaks, reliable and rapid tools are needed. Herein, we compared a rapid antigen test based on active microfluidic technology to an RT-qPCR assay in pediatric and young adult patients admitted to the Pediatric Emergency Unit of a Children’s Hospital. Nasopharyngeal swabs collected from patients with suspected COVID-19 disease and from those without COVID-19 related symptoms, but requiring hospitalization, were performed with both antigen test and RT-qPCR assays. We included 375 patients with a median age of 5 years in the study, with an estimated overall prevalence of 7.2%. Overall, we observed a specificity of 97.4% (95% CI: 94.9–98.7) and a sensitivity of 66.6% (95% CI: 46.0–82.7) with a positive likelihood ratio (LR+) of 25.8 (95% CI: 12.8–51.8). In the subgroup of symptomatic patients, the specificity and the sensitivity were 95.2% (95% CI: 89.4–98.0) and 80.0% (95% CI: 44.2–96.5) respectively; LR+ was 16.6 (95% CI: 7.19–38.6). In the asymptomatic subset, the performance showed a specificity of 98.7% (95% CI: 95.8–99.7), a sensitivity of 58.8% (95% CI: 33.5–80.6), and an LR+ of 43.7 (95% CI: 13.3–144.0). Compared to RT-qPCR, the new microfluidic-based antigen test showed higher specificity (>95%) in the pediatric population, thus representing a suitable point-of-care testing (POCT) in a clinical setting with low prevalence of COVID-19.
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spelling doaj.art-9e3409f2f8b64c11b1690a3329cb31832024-01-26T18:47:37ZengMDPI AGViruses1999-49152023-12-011614110.3390/v16010041Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young AdultsChristian Leli0Lidia Ferrara1Paolo Bottino2Cristina Bara3Iacopo Megna4Serena Penpa5Enrico Felici6Antonio Maconi7Andrea Rocchetti8Microbiology and Virology Laboratory, A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyMicrobiology and Virology Laboratory, A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyMicrobiology and Virology Laboratory, A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyMicrobiology and Virology Laboratory, A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyResearch and Innovation Department (DAIRI), A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyResearch and Innovation Department (DAIRI), A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyPediatric and Pediatric Emergency Unit, A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyResearch and Innovation Department (DAIRI), A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyMicrobiology and Virology Laboratory, A.O. “SS. Antonio e Biagio e C. Arrigo”, Via Venezia 16, 15121 Alessandria, ItalyTo carry out effective and quick identification of SARS-CoV-2 from nasopharyngeal swabs and contain outbreaks, reliable and rapid tools are needed. Herein, we compared a rapid antigen test based on active microfluidic technology to an RT-qPCR assay in pediatric and young adult patients admitted to the Pediatric Emergency Unit of a Children’s Hospital. Nasopharyngeal swabs collected from patients with suspected COVID-19 disease and from those without COVID-19 related symptoms, but requiring hospitalization, were performed with both antigen test and RT-qPCR assays. We included 375 patients with a median age of 5 years in the study, with an estimated overall prevalence of 7.2%. Overall, we observed a specificity of 97.4% (95% CI: 94.9–98.7) and a sensitivity of 66.6% (95% CI: 46.0–82.7) with a positive likelihood ratio (LR+) of 25.8 (95% CI: 12.8–51.8). In the subgroup of symptomatic patients, the specificity and the sensitivity were 95.2% (95% CI: 89.4–98.0) and 80.0% (95% CI: 44.2–96.5) respectively; LR+ was 16.6 (95% CI: 7.19–38.6). In the asymptomatic subset, the performance showed a specificity of 98.7% (95% CI: 95.8–99.7), a sensitivity of 58.8% (95% CI: 33.5–80.6), and an LR+ of 43.7 (95% CI: 13.3–144.0). Compared to RT-qPCR, the new microfluidic-based antigen test showed higher specificity (>95%) in the pediatric population, thus representing a suitable point-of-care testing (POCT) in a clinical setting with low prevalence of COVID-19.https://www.mdpi.com/1999-4915/16/1/41COVID-19SARS-CoV-2microfluidicPOCTpediatric emergency medicine
spellingShingle Christian Leli
Lidia Ferrara
Paolo Bottino
Cristina Bara
Iacopo Megna
Serena Penpa
Enrico Felici
Antonio Maconi
Andrea Rocchetti
Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults
Viruses
COVID-19
SARS-CoV-2
microfluidic
POCT
pediatric emergency medicine
title Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults
title_full Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults
title_fullStr Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults
title_full_unstemmed Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults
title_short Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults
title_sort application of a sars cov 2 antigen rapid immunoassay based on active microfluidic technology in a setting of children and young adults
topic COVID-19
SARS-CoV-2
microfluidic
POCT
pediatric emergency medicine
url https://www.mdpi.com/1999-4915/16/1/41
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