FilmArray® respiratory panel performance in respiratory samples from neonatal care units Antonio Piralla a , Giovanna Lunghi b , Elena Percivalle a , Cristina Viganò b , Teresa Nasta b , Lorenza Pugni c , Fabio Mosca c , Mauro Stronati d , Erminio Torresani b , Fausto Baldanti a, ⁎ a Molecular Virology Unit, Microbiology and Virology Department, Fondazione IRCCS Policlinico San Matteo, 27100, Pavia, Italy b Virology Unit; Fondazione Cà Granda Ospedale Maggiore, Policlinico, Milano, Italy c Neonatology and Intensive Neonatal Care Unit, Fondazione Cà Granda Ospedale Maggiore, Policlinico, Milano, Italy d Neonatal Department, Neonatology and Intensive Neonatal Care, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy abstract article info Article history: Received 8 November 2013 Accepted 7 February 2014 Available online 24 February 2014 Keywords: Respiratory viruses Multiple PCR tests FilmArray FilmArray Respiratory Panel (RP) (Idaho Technology, Inc., Salt Lake City, UT, USA) performance was retrospectively evaluated in respiratory samples collected from neonates in 2 reference neonatology units. Using the FilmArray RP assay, 121/152 (79.6%) samples were positive for at least 1 respiratory virus, while 31/ 152 (20.4%) were negative. FilmArray RP results were concordant in 68/72 (94.4%) respiratory samples tested with laboratory-developed real-time PCR assays, while in 4/72 (5.6%) samples, the FilmArray RP assay detected an additional virus (2 human rhinovirus/enterovirus and 2 bocavirus). In addition, FilmArray RP results for 70 of 80 (87.5%) respiratory samples tested were concordant with the Seegene Seeplex RV15® detection assay (Seegene, Inc., Seoul, South Korea), while 10/80 (12.5%) were discordant. The advantages of the FilmArray RP are the rapid detection of respiratory viruses (1 hour), the wide number of pathogens detectable in a single assay, and the reduced hands-on time. © 2014 Elsevier Inc. All rights reserved. 1. Introduction Viral respiratory outbreaks in neonatal care units are burdened by high morbidity and mortality, and their management implies high healthcare costs (Civardi et al., 2013; Nair et al., 2013). Several community-acquired viruses are responsible for respiratory infections in newborns that give rise to nosocomial outbreaks (Gelber and Ratner, 2002; Faden et al., 2005; Gagneur et al., 2008). Conventional infection control methods (such as hand hygiene and patient isolation and/or cohorting) are recommended, but adoption of rapid, sensitive, and specific diagnostic tools is mandatory for the management and antiviral treatment of these severe clinical conditions. The FilmArray Respiratory Panel (RP) (Idaho Technology, Inc., Salt Lake City, UT, USA), which consists of a pouch system with a multiplex PCR test, provides the detection of 18 viruses and 3 bacterial respiratory pathogens in about 1 hour. The system requires only 3– 5 minutes of total hands-on time to process 1 sample. In this study, FilmArray RP performance was evaluated in 2 independent laborato- ries with respiratory samples collected from neonatal patients. 2. Material and methods 2.1. Study population and samples A retrospective study was conducted on 152 respiratory samples stored at the Fondazione IRCCS Policlicnico San Matteo, Pavia, and Fondazione Cà Granda Ospedale Maggiore, Policlinico, Milano between 2011 and 2013 from as many neonates (age b30 days). Samples included 149 (97.9%) nasopharyngeal aspirates, 1 (0.7%) nasal swab, 1 (0.7%) bronchoalveolar lavage, and 1 (0.7%) tracheal aspirate. This retrospective study was approved by the institutional review board (IRB) of both centres. In addition, the study was performed according to guidelines of the IRB on the use of biologic specimens for scientific purposes in keeping with Italian law (art.13 D.Lgs 196/2003). 2.2. FilmArray RP The FilmArray RP detected the following agents: human respira- tory syncytial virus (hRSV), human metapneumovirus (hMPV), influenza A virus, influenza A/H1 virus, influenza A/H3 virus, influenza A/H1N1pdm09 virus, influenza virus B, human adenovirus (hAdV), human parainfluenza virus types 1–4 (hPIV1-4), human rhinovirus (HRV), human enterovirus (HEV), human coronavirus (hCoV)-OC43, hCoV-229E, hCoV-NL63, hCoV-HKU1, bocavirus (hBoV), Bordetella Diagnostic Microbiology and Infectious Disease 79 (2014) 183–186 ⁎ Corresponding author. Tel.: +39-0382-502420; fax +39-0382-502599. E-mail address: f.baldanti@smatteo.pv.it (F. Baldanti). http://dx.doi.org/10.1016/j.diagmicrobio.2014.02.010 0732-8893/© 2014 Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect Diagnostic Microbiology and Infectious Disease journal homepage: www.elsevier.com/locate/diagmicrobio