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Updated: May 28, 2026

High-throughput Detection of Respiratory Pathogens in Animal Specimens by Nanoscale PCR
Published on: November 28, 2016
Comparison of the FilmArray Respiratory Panel and Prodesse real-time PCR assays for detection of respiratory
M J Loeffelholz1, D L Pong, R B Pyles
1Department of Pathology, University of Texas Medical Branch, 301 University Blvd., Galveston, TX 77555-0740, USA. mjloeffe@utmb.edu
Abstract:
We compared the diagnostic performance and overall respiratory pathogen detection rate of the premarket version of the FilmArray Respiratory Panel (RP) multiplex PCR assay (Idaho Technology, Inc., Salt Lake City, UT) with those of the Food and Drug Administration (FDA)-cleared Prodesse ProFlu+, ProFAST+, ProParaflu+, Pro hMPV+, and ProAdeno+ real-time PCR assays (Gen-Probe, San Diego, CA). The assays were performed on a panel of 192 nasopharyngeal-secretion specimens collected from 81 children under 1 year of age with upper respiratory tract symptoms. To resolve discordant results and confirm pathogens detected only by the larger FilmArray panel, we performed laboratory-developed real-time PCR assays. Among viruses detectable by both commercial assays (adenovirus, human metapneumovirus, influenza A virus, influenza B virus, parainfluenza viruses 1 to 3, and respiratory syncytial virus), the FilmArray and Prodesse assays showed good overall agreement (181/192 [94.3%]; kappa = 0.87; 95% CI, 0.79 to 0.94). FilmArray RP detected more parainfluenza viruses 1 and 3 than ProParaflu+ (18 versus 13) while ProAdeno+ detected more adenoviruses (11 versus 6), but these differences were not statistically significant. Additionally, FilmArray RP detected 138 pathogens (confirmed as true positives) not included in the Prodesse assays (rhinovirus [RV]/enterovirus [EV], 118; bocavirus, 8; coronavirus, 7; parainfluenza virus 4, 4; Mycoplasma pneumoniae, 1). FilmArray RP was cleared by the FDA following the completion of this study. The FDA-cleared version includes the following targets: adenovirus, coronaviruses HKU1 and NL63, human metapneumovirus (hMPV), influenza A virus (to type level only), influenza A H1 seasonal virus, influenza A H3 seasonal virus, influenza A virus H1-2009, influenza B virus, parainfluenza viruses 1 to 4, respiratory syncytial virus (RSV), and RV/EV (no differentiation). The larger panel in the FilmArray RP assay allowed the detection of additional respiratory pathogens compared to the Prodesse assays. In this population of young children with upper respiratory tract infection, RV/EV accounted for the majority of the additional pathogens detected by FilmArray RP.
Insights
The FilmArray Respiratory Panel (RP) multiplex PCR assay detected more respiratory pathogens than the Prodesse real-time PCR assays in young children. This enhanced diagnostic performance, particularly for rhinovirus/enterovirus, improves detection of common respiratory infections.
Area of Science:
- Clinical Microbiology
- Molecular Diagnostics
- Infectious Diseases
Background:
- Multiplex PCR assays offer comprehensive detection of respiratory pathogens.
- Accurate and rapid diagnosis is crucial for managing pediatric respiratory tract infections.
- Comparing diagnostic performance of novel multiplex assays against established methods is essential.
Purpose of the Study:
- To compare the diagnostic performance and pathogen detection rates of the FilmArray Respiratory Panel (RP) assay with Food and Drug Administration (FDA)-cleared Prodesse real-time PCR assays.
- To evaluate the FilmArray RP's ability to detect pathogens not included in the Prodesse panels.
- To assess the utility of FilmArray RP in a cohort of young children with upper respiratory tract symptoms.
Main Methods:
- A panel of 192 nasopharyngeal specimens from children under 1 year old was tested.
- Diagnostic performance was compared between the premarket FilmArray RP and FDA-cleared Prodesse assays.
- Laboratory-developed real-time PCR assays were used to resolve discordant results and confirm novel pathogen detections.
Main Results:
- The FilmArray RP and Prodesse assays showed good overall agreement (94.3%) for commonly detected viruses.
- FilmArray RP detected significantly more parainfluenza viruses 1 and 3, and adenoviruses compared to specific Prodesse assays.
- FilmArray RP identified 138 additional pathogens, predominantly rhinovirus/enterovirus (RV/EV), not detected by Prodesse assays.
Conclusions:
- The FilmArray RP assay demonstrates superior diagnostic performance by detecting a broader range of respiratory pathogens compared to existing Prodesse assays.
- The increased detection of pathogens like RV/EV by FilmArray RP is significant in young children with upper respiratory tract infections.
- The FilmArray RP assay provides a more comprehensive etiological diagnosis for pediatric respiratory illnesses.
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