학술논문
Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults
Document Type
Academic Journal
Author
Source
Viruses. December 2023, Vol. 16 Issue 1
Subject
Language
English
ISSN
1999-4915
Abstract
Author(s): Christian Leli [1]; Lidia Ferrara [1]; Paolo Bottino (corresponding author) [1,*]; Cristina Bara [1]; Iacopo Megna [2]; Serena Penpa [2]; Enrico Felici [3]; Antonio Maconi [2]; Andrea Rocchetti [1] [...]
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.
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.