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Feasibility and Effectiveness Assessment of SARS-CoV-2 Antigenic Tests in Mass Screening of a Pediatric Population and Correlation with the Kinetics of Viral Loads.
Lanari, Marcello; Biserni, Giovanni Battista; Pavoni, Matteo; Borgatti, Eva Caterina; Leone, Marta; Corsini, Ilaria; Lazzarotto, Tiziana.
  • Lanari M; Pediatric Emergency Unit, Department of Medical and Surgical Sciences, IRCCS Azienda Ospedaliero-Universitaria, Polyclinic of St.Orsola, University of Bologna, 40138 Bologna, Italy.
  • Biserni GB; Specialty School of Pediatrics-Alma Mater Studiorum-University of Bologna, 40138 Bologna, Italy.
  • Pavoni M; Microbiology Unit, Department of Specialized, Experimental, and Diagnostic Medicine, IRCCS Azienda Ospedaliero-Universitaria, Polyclinic of St.Orsola, University of Bologna, 40138 Bologna, Italy.
  • Borgatti EC; Microbiology Unit, Department of Specialized, Experimental, and Diagnostic Medicine, IRCCS Azienda Ospedaliero-Universitaria, Polyclinic of St.Orsola, University of Bologna, 40138 Bologna, Italy.
  • Leone M; Microbiology Unit, Department of Specialized, Experimental, and Diagnostic Medicine, IRCCS Azienda Ospedaliero-Universitaria, Polyclinic of St.Orsola, University of Bologna, 40138 Bologna, Italy.
  • Corsini I; Pediatric Emergency Unit, Department of Medical and Surgical Sciences, IRCCS Azienda Ospedaliero-Universitaria, Polyclinic of St.Orsola, University of Bologna, 40138 Bologna, Italy.
  • Lazzarotto T; Microbiology Unit, Department of Specialized, Experimental, and Diagnostic Medicine, IRCCS Azienda Ospedaliero-Universitaria, Polyclinic of St.Orsola, University of Bologna, 40138 Bologna, Italy.
Viruses ; 13(10)2021 10 14.
Article in English | MEDLINE | ID: covidwho-1470995
ABSTRACT
The gold standard for diagnosis of SARS-CoV-2 infection has been nucleic acid amplification tests (NAAT). However, rapid antigen detection kits (Ag-RDTs), may offer advantages over NAAT in mass screening, generating results in minutes, both as laboratory-based test or point-of-care (POC) use for clinicians, at a lower cost. We assessed two different POC Ag-RDTs in mass screening versus NAAT for SARS-CoV-2 in a cohort of pediatric patients admitted to the Pediatric Emergency Unit of IRCCS-Polyclinic of Sant'Orsola, Bologna (from November 2020 to April 2021). All patients were screened with nasopharyngeal swabs for the detection of SARS-CoV-2-RNA and for antigen tests. Results were obtained from 1146 patients. The COVID-19 Ag FIA kit showed a baseline sensitivity of 53.8% (CI 35.4-71.4%), baseline specificity 99.7% (CI 98.4-100%) and overall accuracy of 80% (95% CI 0.68-0.91); the AFIAS COVID-19 Ag kit, baseline sensitivity of 86.4% (CI 75.0-93.9%), baseline specificity 98.3% (CI 97.1-99.1%) and overall accuracy of 95.3% (95% CI 0.92-0.99). In both tests, some samples showed very low viral load and negative Ag-RDT. This disagreement may reflect the positive inability of Ag-RDTs of detecting antigen in late phase of infection. Among all cases with positive molecular test and negative antigen test, none showed viral loads > 106 copies/mL. Finally, we found one false Ag-RDTs negative result (low cycle thresholds; 9 × 105 copies/mL). Our results suggest that both Ag-RDTs showed good performances in detection of high viral load samples, making it a feasible and effective tool for mass screening in actively infected children.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Load / COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Child / Child, preschool / Female / Humans / Male Language: English Year: 2021 Document Type: Article Affiliation country: V13102071

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Load / COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Child / Child, preschool / Female / Humans / Male Language: English Year: 2021 Document Type: Article Affiliation country: V13102071