Miernyk K, Bulkow L, DeByle C, et al. Performance of a rapid antigen test (Binax NOW(R) RSV) for diagnosis of respiratory syncytial virus compared with real-time polymerase chain reaction in a pediatric population

Alaska Native Tribal Health Consortium, 4055 Tudor Centre Dr., Anchorage, AK 99508, USA.
Journal of clinical virology: the official publication of the Pan American Society for Clinical Virology (Impact Factor: 3.02). 03/2011; 50(3):240-3. DOI: 10.1016/j.jcv.2010.11.011
Source: PubMed


Infants from Alaska's Yukon-Kuskokwim Delta (YKD) have a high respiratory syncytial virus (RSV) hospitalization rate (104/1000/yr). Appropriate patient management requires rapid and accurate RSV diagnosis. Antigen-based methods are often used in clinical settings, but these tests can lack sensitivity.
We compared Binax NOW(®) RSV (BN) used for RSV diagnosis in the YKD hospital with a real-time polymerase chain reaction assay (RT-qPCR) used for viral surveillance.
Between October 2005 and September 2007 we obtained nasopharyngeal washes (NPW) from children <3 years hospitalized with a lower respiratory tract infection. The NPW were tested using BN and RT-qPCR.
79/311 (25%) children had RSV infection as determined by RT-qPCR. As compared with RT-qPCR, sensitivity and specificity of BN were 72% and 97%, respectively. The sensitivity of BN was higher in children <1 year compared with children ≥ 1 year (79% vs. 52%; p=0.025), children with bronchiolitis compared with children without bronchiolitis (89% vs. 38%; p<0.001), and children with a shorter duration of symptoms before testing (0-1 (92%) vs. 2-4 (78%) vs. 5+ (65%) days; p=0.04). The median RSV viral load in NPW positive by BN and RT-qPCR was 1.01 × 10(9)copies/mL vs. a median of 5.25 × 10(7)copies/mL for NPW positive by RT-qPCR only (p<0.001).
RT-qPCR is more sensitive than BN in detecting RSV infection. BN sensitivity is high in children with bronchiolitis, but the sensitivity is low when children present with a non-bronchiolitis illness, especially after a longer duration of symptoms before testing.

Download full-text


Available from: Lisa R Bulkow, Feb 25, 2015
  • Source
    • "It is also possible that the lower diagnostic sensitivity detected in our study was not connected with the differences between HRSV and BRSV, but was rather a result of the different type of samples used for testing . Nasopharyngeal washes are described as a recommended specimen for immunchromatographic tests (Selvarangan et al. 2008) and previous evaluations were done based on this type of sample (Wybo et al. 2009, Miernyk et al. 2011, Sánchez-Yebra et al. 2012). However, due to the fact that collection of nasal washes from animals could be complicated, we decided to use nasal swabs as they are much easier to obtain in field conditions. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Three different rapid strip tests: TRU RSV, BinaxNOW RSV and RSV Respi-strip were compared with RT-PCR and ELISA BRSV Ag for the ability to detect bovine respiratory syncytial virus (BRSV) in nasal swabs collected from calves experimentally vaccinated with live vaccine Rispoval RS-PI3. The reference strains of BRSV (375 and A51908) were detected by ELISA BRSV Ag whereas the strains of human respiratory syncytial virus (HRSV) and bovine parainfluenza virus type 3 (BPIV-3) were not. All rapid strip tests as well as RT-PCR reacted positively both to HRSV and BRSV reference strains and negatively to BPIV-3. The detection limit for RT-PCR was 39.1 TCID50 (strain 375 of BRSV), whereas for each of the rapid tests it was approximately 156 TCID50 and 312 TCID50 for antigen ELISA. Diagnostic sensitivity in detecting BRSV in nasal swabs for TRU RSV and RSV Respi-strip tests was 33% and 50% for BinaxNOW RSV. Diagnostic specificity of TRU RSV was 100%, whereas for both BinaxNOW and Respi-strip it was 87%. We concluded that TRU RSV could be used as a supportive rapid test for BRSV screening in nasal swabs taken directly on a farm. However, due to the small group of animals used in the experiment, the results should be regarded as preliminary and the study should be repeated on a larger number of animals.
    Full-text · Article · Dec 2012 · Polish journal of veterinary sciences
  • [Show abstract] [Hide abstract]
    ABSTRACT: The appearance of eight new respiratory viruses, including the SARS coronavirus in 2003 and swine-origin influenza A/H1N1 in 2009, in the human population in the past nine years has tested the ability of virology laboratories to develop diagnostic tests to identify these viruses. Nucleic acid based amplification tests (NATs) for respiratory viruses were first introduced two decades ago and today are utilized for the detection of both conventional and emerging viruses. These tests are more sensitive than other diagnostic approaches, including virus isolation in cell culture, shell vial culture (SVC), antigen detection by direct fluorescent antibody (DFA) staining, and rapid enzyme immunoassay (EIA), and now form the backbone of clinical virology laboratory testing around the world. NATs not only provide fast, accurate and sensitive detection of respiratory viruses in clinical specimens but also have increased our understanding of the epidemiology of both new emerging viruses such as the pandemic H1N1 influenza virus of 2009, and conventional viruses such as the common cold viruses, including rhinovirus and coronavirus. Multiplex polymerase chain reaction (PCR) assays introduced in the last five years detect up to 19 different viruses in a single test. Several multiplex PCR tests are now commercially available and tests are working their way into clinical laboratories. The final chapter in the evolution of respiratory virus diagnostics has been the addition of allelic discrimination and detection of single nucleotide polymorphisms associated with antiviral resistance. These assays are now being multiplexed with primary detection and subtyping assays, especially in the case of influenza virus. These resistance assays, together with viral load assays, will enable clinical laboratories to provide physicians with new and important information for optimal treatment of respiratory virus infections.
    No preview · Article · Sep 2011 · Critical Reviews in Clinical Laboratory Sciences
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The FilmArray Respiratory Panel (RP) multiplexed nucleic acid amplification test (Idaho Technology, Inc., Salt Lake City, UT) was compared to laboratory-developed real-time PCR assays for the detection of various respiratory viruses and certain bacterial pathogens. A total of 215 frozen archived pediatric respiratory specimens previously characterized as either negative or positive for one or more pathogens by real-time PCR were examined using the FilmArray RP system. Overall agreement between the FilmArray RP and corresponding real-time PCR assays for shared analytes was 98.6% (kappa = 0.92 [95% confidence interval (CI), 0.89 to 0.94]). The combined positive percent agreement was 89.4% (95% CI, 85.4 to 92.6); the negative percent agreement was 99.6% (95% CI, 99.2 to 99.8). The mean real-time PCR threshold cycle (C(T)) value for specimens with discordant results was 36.46 ± 4.54. Detection of coinfections and correct identification of influenza A virus subtypes were comparable to those of real-time PCR when using the FilmArray RP. The greatest comparative difference in sensitivity was observed for adenovirus; only 11 of 24 (45.8%; 95% CI, 27.9 to 64.9) clinical specimens positive for adenovirus by real-time PCR were also positive by the FilmArray RP. In addition, upon testing 20 characterized adenovirus serotypes prepared at high and low viral loads, the FilmArray RP did not detect serotypes 6 and 41 at either level and failed to detect serotypes 2, 20, 35, and 37 when viral loads were low. The FilmArray RP system is rapid and extremely user-friendly, with results available in just over 1 h with almost no labor involved. Its low throughput is a significant drawback for laboratories receiving large numbers of specimens, as only a single sample can be processed at a time with one instrument.
    Preview · Article · Nov 2011 · Journal of clinical microbiology
Show more