Evaluation of the ESPLINE® Influenza A & B-N assay for the detection of influenza A and B in nasopharyngeal aspirates.

Laboratory of Microbiology, University Hospital Antwerp, Wilrijkstraat 10, 2650, Edegem, Antwerp, Belgium.
European Journal of Clinical Microbiology (Impact Factor: 2.54). 09/2011; 31(5):761-6. DOI: 10.1007/s10096-011-1372-1
Source: PubMed

ABSTRACT Several direct antigen tests for the detection of influenza often lack sensitivity compared to immunofluorescence (IF) on the specimens and viral culture (VC). We evaluated the performance of a rapid test, the ESPLINE® Influenza A & B-N assay. A total of 302 respiratory specimens were collected at the University Hospital of Antwerp. A first group of 60 samples taken during the H1N1 outbreak (2009-2010) and a second group of 242 samples stored during the seasonal influenza epidemics (2000-2009) were analyzed with the ESPLINE® test. A subset of samples were also evaluated with the BinaxNOW Influenza and the Clearview Exact Influenza. The results were compared to IF on the specimens, VC with IF, and the combination of both, which was considered as the gold standard. The ESPLINE® test's overall sensitivity and specificity were 91% and 97%, during the H1N1 season 80% and 93%, and for the detection of seasonal influenza 93% and 97%, respectively. In comparison to the BinaxNOW Influenza and the Clearview Exact Influenza, all tests demonstrated a similar specificity of 92.0-100% but a significantly different sensitivity of 44.4-86.0%, with the ESPLINE® test being significantly more sensitive. Due to its very good performance and simplicity, the ESPLINE® test facilitates urgent testing. The test seems less sensitive to detect H1N1 compared to seasonal influenza, although the difference is borderline not significant (p = 0.067).

  • [Show abstract] [Hide abstract]
    ABSTRACT: Rapid and accurate diagnosis of influenza (Flu) is important for infection control as well as for patient management. Alere i Influenza A&B is an isothermal nucleic acid amplification-based integrated system for detection and differentiation of FluA and FluB. The performance of the Alere i Influenza A&B was screened using frozen nasopharyngeal swab specimens collected in viral transport media (VTM) that were originally tested fresh with the FilmArray Respiratory Panel (RP) assay during the 2012/2013 influenza outbreak. In total, 360 VTM specimens were selected for Alere i Influenza A&B testing, including 40 FluA H1N1-2009 (FluA-1), 40 FluA H3N2 (FluA-3), 37 FluA "equivocal" or "no subtype detected" (FluA-u), 41 FluB and 202 Flu-negatives as initially determined by the FilmArray RP assay. The Alere assay showed sensitivities of 87.2%, 92.5%, 25.0% and 97.4% for FluA-1, FluA-3, FluA-u, and FluB, respectively, after discordant resolution by Prodesse ProFLU+ PCR. The specificities were 100% for both FluA and FluB. In general, the Alere i Influenza A&B provided good sensitivity although the assay did show poorer sensitivity with samples determined to be of low FluA titer by Prodesse ProFlu+ PCR (mean real-time PCR threshold cycle (CT) value of 31.9 ± 2.0), which included the majority of the samples called FluA "equivocal" or "no subtype detected" by a single BioFire FilmArray RP test. The integrated, rapid and simple characteristics of the Alere i Influenza A&B make it potential for point-of-care testing with a test turnaround time less than 15 minutes.
    Journal of Clinical Microbiology 07/2014; 52(9). DOI:10.1128/JCM.01132-14
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: BACKGROUND: Rapid etiological diagnosis of a respiratory virus infection may have impact on antiviral and antibiotic therapy, patient cohorting, and prediction of the clinical course. Most point-of-care tests for detection of respiratory viruses have limitations in diagnostic performance and clinical usability. A novel, multianalyte point-of-care antigen detection test system (mariPOC(®); ArcDia International Oy Ltd., Turku, Finland) detects eight respiratory viruses (influenza A and B viruses, respiratory syncytial virus (RSV), adenovirus, human metapneumovirus, and parainfluenza type 1, 2, and 3 viruses) from a single nasopharyngeal swab specimen by a fully automated, random-access immunoassay method. OBJECTIVES: To evaluate mariPOC(®) point-of-care test system in comparison with reverse transcription polymerase chain reaction (RT-PCR) in a pediatric emergency department setting. STUDY DESIGN: Prospectively collected samples from 158 children (mean age, 1.8 years) with respiratory symptoms and/or fever were analyzed both by mariPOC(®) and by multiplex RT-PCR. RESULTS: The sensitivities and specificities (95% confidence intervals) of the mariPOC(®) test were for influenza A (n=7), 71% (38-100) and 100%; influenza B (n=22), 86% (72-100) and 98% (95-100); RSV (n=35), 89% (78-99) and 100%; adenovirus (n=12), 25% (1-50) and 97% (95-99); and for human metapneumovirus (n=8), 50% (15-85) and 100%, respectively. Parainfluenzaviruses were detected only in five patients. CONCLUSIONS: This novel point-of-care test system is a rapid, practical, and specific method for simultaneous detection of eight respiratory viruses. Compared with RT-PCR, its sensitivity is moderately high for detection of RSV and influenza viruses, and low for adenovirus.
    Journal of clinical virology: the official publication of the Pan American Society for Clinical Virology 03/2013; 57(2). DOI:10.1016/j.jcv.2013.02.011
  • [Show abstract] [Hide abstract]
    ABSTRACT: : Postexposure prophylaxis (PEP) using neuraminidase inhibitors against exposure to influenza virus has been well studied in household settings but not in nosocomial settings in pediatric wards. : We used oseltamivir or zanamivir as PEP in our pediatric wards. All influenza cases were diagnosed by the influenza rapid diagnostic test. : Between 2003 and 2011, there were 20 nosocomial introductions of influenza (10 were A, 9 were B and 1 was undetermined). The index cases consisted of 17 inpatients, 2 parents and 1 medical staff member. The 17 inpatients had been admitted to the hospital for reasons other than infectious disease and they developed influenza after hospitalization. Among the 81 contacts, 28 (35%) were exposed to influenza A, and 52 (64%) were exposed to influenza B. The rate of secondary infection among contacts not given PEP was 29% (5/17), and the rate among contacts given PEP was significantly lower, 3% (2/63; P = 0.004). The 2 infected contacts who had been given PEP were both influenza B cases, and both had received oseltamivir. The contacts who received PEP within 24 hours (59), for influenza A (23) and those who received zanamivir (15) did not develop influenza. No adverse events were reported. : PEP using oseltamivir or zanamivir for unexpected occurrences of nosocomial influenza in pediatric wards is safe and effective. The influenza rapid diagnostic test that we used was helpful for detecting nosocomial influenza in children.
    The Pediatric Infectious Disease Journal 05/2012; 31(11):1119-23. DOI:10.1097/INF.0b013e318260265a