title: Evaluation of novel second-generation RSV and influenza rapid tests at the point of care.
abstract: Acute respiratory infections represent common pediatric emergencies. Infection control warrants immediate and accurate diagnoses. In the past, first-generation respiratory syncytial virus (RSV) rapid tests (strip tests) have shown suboptimal sensitivities. In 2013, the Food and Drug Administration licensed a second-generation RSV rapid test providing user-independent readouts (SOFIA™-RSV) using automated fluorescence assay technology known to yield superior results with influenza rapid testing. We are reporting the first point-of-care evaluation of the SOFIA™-RSV rapid test. In the Charité Influenza-Like Disease Cohort, 686 nasopharyngeal samples were tested in parallel with SOFIA™-RSV and SOFIA™-Influenza A+B. Compared to real-time PCR, SOFIA™-RSV sensitivities/specificities were 78.6%/93.9%, respectively (SOFIA™-Influenza A: 80.6%/99.3%). Performance was greatest in patients below 2 years of age with a test sensitivity of 81.8%. RSV sensitivities were highest (85%) in the first 2 days of illness and with nasopharyngeal compared to nasal swabs (P=0.055, McNemar's test). Second-generation RSV and influenza rapid testing provides highly accurate results facilitating timely patient cohortation and management.
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: tuttlerc@gmail.com.
authors.forename: Ryan
authors.initials: R
authors.lastname: Tuttle
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: weick.anja@googlemail.com.
authors.forename: Anja
authors.initials: A
authors.lastname: Weick
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: wiebke-sabrina.schwarz@charite.de.
authors.forename: Wiebke Sabrina
authors.initials: WS
authors.lastname: Schwarz
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: xi.chen@charite.de.
authors.forename: Xi
authors.initials: X
authors.lastname: Chen
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: patrick.obermeier@charite.de.
authors.forename: Patrick
authors.initials: P
authors.lastname: Obermeier
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: lea.seeber@charite.de.
authors.forename: Lea
authors.initials: L
authors.lastname: Seeber
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: franziska.tief@charite.de.
authors.forename: Franziska
authors.initials: F
authors.lastname: Tief
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: susann.muehlhans@charite.de.
authors.forename: Susann
authors.initials: S
authors.lastname: Muehlhans
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: katharina.karsch@charite.de.
authors.forename: Katharina
authors.initials: K
authors.lastname: Karsch
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: christian.peiser@charite.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Peiser
authors.affiliation: Division for Influenza and Other Respiratory Viruses, National Reference Centre for Influenza, Robert-Koch Institute, Nordufer 20, Berlin 13353, Germany. Electronic address: DuweS@rki.de.
authors.forename: Susanne
authors.initials: S
authors.lastname: Duwe
authors.affiliation: Division for Influenza and Other Respiratory Viruses, National Reference Centre for Influenza, Robert-Koch Institute, Nordufer 20, Berlin 13353, Germany. Electronic address: SchweigerB@rki.de.
authors.forename: Brunhilde
authors.initials: B
authors.lastname: Schweiger
authors.affiliation: Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: barbara.rath@gmail.com.
authors.forename: Barbara
authors.initials: B
authors.lastname: Rath
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009980:Influenza A virus / Q000302:isolation & purification; D009981:Influenza B virus / Q000302:isolation & purification; D007251:Influenza, Human / Q000175:diagnosis*; D008297:Male; D009305:Nasopharynx / Q000821:virology; D019095:Point-of-Care Systems; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis*; D012136:Respiratory Syncytial Viruses / Q000302:isolation & purification; D012680:Sensitivity and Specificity; D013997:Time Factors
keywords: Influenza-like illness; Minimally-invasive testing; Point-of-care diagnostics; Rapid testing; Respiratory syncytial virus