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J Clin Pathol doi:10.1136/jcp.2009.066688

Clinical Evaluation of NucliSENS Magnetic Extraction and NucliSENS Analytic Specific Reagents for the Real Time Detection of Respiratory Syncytial Virus (RSV) in Pediatric Respiratory Specimens

  1. Ryhana Manji (rmanji{at}nshs.edu)
  1. North Shore-LIJ Health System Labs, United States
    1. Madhavi Lotlikar (mlotlika{at}nshs.edu)
    1. North Shore-LIJ Health System Labs, United States
      1. Fan Zhang (fzhang{at}nshs.edu)
      1. North Shore-LIJ Health System Labs, United States
        1. Christine Ginocchio (cginocch{at}nshs.edu)
        1. North Shore-LIJ Health System Labs, United States
          • Published Online First 21 July 2009

          Abstract

          Aims: To evaluate the combination of NucliSENS magnetic extraction and NucliSENS analytic 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 pediatric samples (n=603) and a RSV specific inhibition control (R-IC) were co-extracted using the miniMAG and/or the easyMAG. Nucleic acid sequenced based amplification (NASBA) and molecular beacon detection of RSV and R-IC were performed using NucliSENS ASRs (NRSVA) and the NucliSENS EasyQ Analyzer. NRSVA results were compared to R-Mix culture and direct fluorescent antibody detection (DFA).

          Results: NRSVA analytical specificity was 100%. NRSVA limit of detection was 5-20 RNA copies/reaction. Pre discordant 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%, 98.8%). RSV was detected in 17.8% of the samples and in 7 co-infections. Children with proven RSV infection, compared to children without a pathogen identified, had shorter median hospitalization stays (2 days versus 3 days, P=0.035), used less antibiotics (54% versus 69%) and shorter durations of antibiotic therapy (6.2 days versus 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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