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 Adminis...

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Veröffentlicht in:Diagnostic microbiology and infectious disease 2015-03, Vol.81 (3), p.171-176
Hauptverfasser: Tuttle, Ryan, Weick, Anja, Schwarz, Wiebke Sabrina, Chen, Xi, Obermeier, Patrick, Seeber, Lea, Tief, Franziska, Muehlhans, Susann, Karsch, Katharina, Peiser, Christian, Duwe, Susanne, Schweiger, Brunhilde, Rath, Barbara
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container_end_page 176
container_issue 3
container_start_page 171
container_title Diagnostic microbiology and infectious disease
container_volume 81
creator Tuttle, Ryan
Weick, Anja
Schwarz, Wiebke Sabrina
Chen, Xi
Obermeier, Patrick
Seeber, Lea
Tief, Franziska
Muehlhans, Susann
Karsch, Katharina
Peiser, Christian
Duwe, Susanne
Schweiger, Brunhilde
Rath, Barbara
description 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.
doi_str_mv 10.1016/j.diagmicrobio.2014.11.013
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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). 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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). 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subjects Adolescent
Child
Child, Preschool
Diagnostic Tests, Routine - methods
Female
Humans
Infant
Infant, Newborn
Infectious Disease
Influenza A virus - isolation & purification
Influenza B virus - isolation & purification
Influenza, Human - diagnosis
Influenza-like illness
Internal Medicine
Male
Minimally-invasive testing
Nasopharynx - virology
Point-of-care diagnostics
Point-of-Care Systems
Prospective Studies
Rapid testing
Respiratory syncytial virus
Respiratory Syncytial Virus Infections - diagnosis
Respiratory Syncytial Viruses - isolation & purification
Sensitivity and Specificity
Time Factors
title Evaluation of novel second-generation RSV and influenza rapid tests at the point of care
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