Sara Gomez1, Columbiana Prieto2, Lola Folgueira2. 1. Department of Clinical Microbiology, Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: microsaragg@gmail.com. 2. Department of Clinical Microbiology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Abstract
BACKGROUND: Respiratory viruses RSV and influenza A and B viruses are responsible for important disease outbreaks during the winter season in temperate climate regions. Rapid diagnostic tests (RDTs) are assays designed to yield a rapid diagnosis, which facilitates patient management. The Sofia Influenza A+B Fluorescence Immunoassay and Sofia RSV Fluorescence Immunoassay are RDTs for Influenza and RSV detection that employ a new technology to enhance their sensitivity. OBJECTIVES: Sensitivity, specificity and positive and negative predictive values of the assays were calculated compared with the reference diagnostic method: real-time RT-PCR. STUDY DESIGN: A prospective evaluation was carried out on 1065 respiratory samples for Sofia Influenza A+B FIA and on 261 samples for Sofia RSV FIA from November 2013 to April 2014. RESULTS: The sensitivities of the Sofia Influenza A+B FIA for influenza A and influenza B detection were, respectively, 75.3% (244/324) and 50.0% (8/16). The sensitivity of the Sofia RSV FIA was 92.1% (128/139). There were no differences in Sofia FIA performance depending on the virus subtype. CONCLUSIONS: The results showed high sensitivity and specificity values for influenza A and RSV detection, but values were lower for influenza B. More information is needed regarding the performance for influenza B given the small number of positive samples assessed.
BACKGROUND:Respiratory viruses RSV and influenza A and B viruses are responsible for important disease outbreaks during the winter season in temperate climate regions. Rapid diagnostic tests (RDTs) are assays designed to yield a rapid diagnosis, which facilitates patient management. The Sofia Influenza A+B Fluorescence Immunoassay and Sofia RSV Fluorescence Immunoassay are RDTs for Influenza and RSV detection that employ a new technology to enhance their sensitivity. OBJECTIVES: Sensitivity, specificity and positive and negative predictive values of the assays were calculated compared with the reference diagnostic method: real-time RT-PCR. STUDY DESIGN: A prospective evaluation was carried out on 1065 respiratory samples for Sofia Influenza A+B FIA and on 261 samples for Sofia RSV FIA from November 2013 to April 2014. RESULTS: The sensitivities of the Sofia Influenza A+B FIA for influenza A and influenza B detection were, respectively, 75.3% (244/324) and 50.0% (8/16). The sensitivity of the Sofia RSV FIA was 92.1% (128/139). There were no differences in Sofia FIA performance depending on the virus subtype. CONCLUSIONS: The results showed high sensitivity and specificity values for influenza A and RSV detection, but values were lower for influenza B. More information is needed regarding the performance for influenza B given the small number of positive samples assessed.
Authors: Christine F Markwalter; Andrew G Kantor; Carson P Moore; Kelly A Richardson; David W Wright Journal: Chem Rev Date: 2018-12-04 Impact factor: 60.622
Authors: Cristalyne Bell; Maureen Goss; Jennifer Birstler; Emily Temte; Guanhua Chen; Peter Shult; Erik Reisdorf; Thomas Haupt; Shari Barlow; Jonathan Temte Journal: PLoS One Date: 2022-05-10 Impact factor: 3.752