Evaluation of novel second-generation RSV and influenza rapid tests at the point of care

Ryan Tuttle; Anja Weick; Wiebke Sabrina Schwarz; Xi Chen; Patrick Obermeier; Lea Seeber; Franziska Tief; Susann Muehlhans; Katharina Karsch; Christian Peiser; Susanne Duwe; Brunhilde Schweiger; Barbara Rath

doi:10.1016/j.diagmicrobio.2014.11.013

Evaluation of novel second-generation RSV and influenza rapid tests at the point of care

Diagn Microbiol Infect Dis. 2015 Mar;81(3):171-6. doi: 10.1016/j.diagmicrobio.2014.11.013. Epub 2014 Dec 3.

Authors

Affiliations

¹ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
² Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
³ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
⁴ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
⁵ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
⁶ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
⁷ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
⁸ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
⁹ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
¹⁰ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].
¹¹ Division for Influenza and Other Respiratory Viruses, National Reference Centre for Influenza, Robert-Koch Institute, Nordufer 20, Berlin 13353, Germany. Electronic address: [email protected].
¹² Division for Influenza and Other Respiratory Viruses, National Reference Centre for Influenza, Robert-Koch Institute, Nordufer 20, Berlin 13353, Germany. Electronic address: [email protected].
¹³ Division of Pneumonology-Immunology, Department of Pediatrics, Charité University Medical Center, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: [email protected].

PMID: 25583129
DOI: 10.1016/j.diagmicrobio.2014.11.013

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.

Keywords: Influenza-like illness; Minimally-invasive testing; Point-of-care diagnostics; Rapid testing; Respiratory syncytial virus.

Publication types

Evaluation Study

MeSH terms

Adolescent
Child
Child, Preschool
Diagnostic Tests, Routine / methods*
Female
Humans
Infant
Infant, Newborn
Influenza A virus / isolation & purification
Influenza B virus / isolation & purification
Influenza, Human / diagnosis*
Male
Nasopharynx / virology
Point-of-Care Systems*
Prospective Studies
Respiratory Syncytial Virus Infections / diagnosis*
Respiratory Syncytial Viruses / isolation & purification
Sensitivity and Specificity
Time Factors