eprintid: 24267 rev_number: 15 eprint_status: archive userid: 1589 dir: disk0/00/02/42/67 datestamp: 2018-05-30 08:36:35 lastmod: 2018-06-18 08:43:36 status_changed: 2018-05-30 08:36:35 type: article metadata_visibility: show creators_name: Schnee, Sarah V. creators_name: Pfeil, Johannes creators_name: Ihling, Clara M. creators_name: Tabatabai, Julia creators_name: Schnitzler, Paul title: Performance of the Alere i RSV assay for point-of-care detection of respiratory syncytial virus in children subjects: 610 divisions: 910500 divisions: 911700 abstract: Background: Respiratory syncytial virus (RSV) is the most important cause of severe acute respiratory tract infection in young children. Alere i RSV is a novel molecular rapid test which identifies respiratory syncytial virus in less than 13 min. Methods: We evaluated the clinical performance of the Alere i RSV assay in a pediatric point-of-care setting during winter season 2016 / 2017. Test results from 518 nasopharyngeal swab samples were compared to a real-time reverse transcription PCR reference standard. Results: The overall sensitivity and specificity of the Alere i RSV test assay was 93% (CI95 89% – 96%) and 96% (CI95 93% – 98%), respectively. Alere i RSV performed well in children of all age groups. An optimal sensitivity of 98% (CI95 94% - 100%) and specificity of 96% (CI95 90% - 99%) was obtained in children < 6 months. In children ≥ 2 years, sensitivity and specificity remained at 87% (CI95 73% – 96%) and 98% (CI95 92% – 100%), respectively. False negative Alere i RSV test results mostly occurred in samples with low viral load (mean CT value 31.1; CI95 29.6 – 32.6). The Alere i RSV assay is easy to use and can be operated after minimal initial training. Test results are available within 13 min, with most RSV positive samples being identified after approximately 5 min. Conclusion: The Alere i RSV assay has the potential to facilitate the detection of RSV in pediatric point-of-care settings. date: 2017 publisher: BioMed Central ; Springer id_scheme: DOI id_number: https://doi.org/10.1186/s12879-017-2855-1 ppn_swb: 1657249573 own_urn: urn:nbn:de:bsz:16-heidok-242679 language: eng bibsort: SCHNEESARAPERFORMANC2017 full_text_status: public publication: BMC Infectious Diseases volume: 17 number: 767 place_of_pub: London ; Berlin ; Heidelberg pagerange: 1-6 issn: 1471-2334 citation: Schnee, Sarah V. ; Pfeil, Johannes ; Ihling, Clara M. ; Tabatabai, Julia ; Schnitzler, Paul (2017) Performance of the Alere i RSV assay for point-of-care detection of respiratory syncytial virus in children. BMC Infectious Diseases, 17 (767). pp. 1-6. ISSN 1471-2334 document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/24267/1/12879_2017_Article_2855.pdf