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Clinical evaluation of NucliSENS magnetic extraction and NucliSENS analytical specific reagents for the real-time detection of respiratory syncytial virus (RSV) in paediatric respiratory specimens
  1. R Manji,
  2. M Lotlikar,
  3. F Zhang,
  4. C C Ginocchio
  1. North Shore—Long Island Jewish Health System Laboratories, Department of Laboratory Medicine, Lake Success, New York, USA
    s
  1. Correspondence to Professor C C Ginocchio, North Shore Long Island Jewish Health System Laboratories, 10 Nevada Drive, Lake Success, NY 11042, USA; cginocch{at}nshs.edu

Abstract

Aims: To evaluate the combination of NucliSENS magnetic extraction and NucliSENS analytical specific reagents (bioMérieux, Marcy L’Etoile, France) for the detection of respiratory syncytial virus (RSV) from a variety of respiratory samples.

Methods: Nucleic acids (NA) from paediatric samples (n = 603) and an RSV-specific inhibition control (R-IC) were coextracted using the miniMAG and/or the easyMAG. Nucleic-acid-sequence-based amplification (NASBA) and molecular beacon detection of RSV and R-IC were performed using NucliSENS analyte-specific reagents (NRSVA) and the NucliSENS EasyQ Analyzer. NRSVA results were compared with R-Mix culture and direct fluorescent antibody detection (DFA).

Results: The NRSVA analytical specificity was 100%, and the NRSVA limit of detection was 5–20 RNA copies/reaction. The prediscordant analysis, sensitivity, specificity, PPV and NPV were, respectively, for R-Mix (64.7%, 100%, 100%, 94.5%); DFA (98.8%, 99.0%, 94.4%, 99.8%); NRSVA (94.1%, 95%, 75.5%, 99%). After discordant analysis, sensitivity, specificity, PPV and NPV were, respectively, for R-Mix (56.7%, 100%, 100%, 92.3%); DFA (87.6%, 99.2%, 95.5%, 97.7%); NRSVA (93.8%, 97%, 85.9%, 99%). RSV was detected in 17.8% of the samples and in seven coinfections. Children with proven RSV infection, compared with children without a pathogen identified, had shorter median hospitalisation stays (2 days vs 3 days, p = 0.035), used fewer antibiotics (54% vs 69%) and had shorter durations of antibiotic therapy (6.2 days vs 9.3 days, p = 0.021), respectively.

Conclusions: NRSVA is sensitive and specific for RSV detection in respiratory samples. The R-IC monitored the test process, including NA extraction, target amplification and detection. The rapid detection of respiratory pathogens can foster appropriate patient management.

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Footnotes

  • Funding This study was funded in part by the Jane and Dayton Brown and Dayton Brown Jr Molecular Diagnostics Laboratory Research Fund.

  • Competing interests This study was funded in part by a research grant from bioMérieux, Marcy L’Etoile, France. CCG has served as a consultant for and has received honoraria from bioMérieux.

  • Ethics approval Ethics approval was provided by Biomedical Research Alliance, Manhasset, New York.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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