Lab Med Online.  2015 Jan;5(1):27-32. 10.3343/lmo.2015.5.1.27.

Comparison of the Clinical Performance of Binax NOW RSV Versus Multiplex RT-PCR for Detection of Respiratory Syncytial Virus

• Son JA
• Kim SH
• Shin JH
• Jeon GW
• Sin JB
• Lee JY
• Kim HR
• Jun KR
• Lee JN
• Song SA

• KMID: 2312264
• DOI: http://doi.org/10.3343/lmo.2015.5.1.27

Abstract

BACKGROUND
Respiratory syncytial virus (RSV) is one of the most important causes of lower respiratory tract infection. The rapid antigen test is a simple, cheap, and quick method for RSV detection, however, it has an acknowledged low sensitivity. The aim of this study is to evaluate the diagnostic performance of the rapid antigen test by comparing it with a multiplex reverse transcription-PCR (RT-PCR).
METHODS
A total of 557 nasopharyngeal aspirates or swabs that were submitted for both a rapid antigen test, Binax NOW RSV (Binax; Alere Scarborough, Inc., USA) and multiplex RT-PCR, Seeplex RV7 (Seegene Inc., Korea) were included in this study. We performed both tests according to the manufacturer's recommendations and analyzed the diagnostic performances of a rapid antigen tests based on the results of multiplex RT-PCR.
RESULTS
Among the 557 specimens, the positive rates determined from the rapid antigen test and multiplex RT-PCR were 12.2% (N=68) and 25.1% (N=140), respectively. The relative sensitivity and specificity of the rapid antigen test were 46.4% and 99.3% based on the multiplex RT-PCR, respectively. Positive and negative predictive values were 95.6% and 84.7%, respectively. The diagnostic sensitivity was lower (28.6%) in children >36 months compared with children < or =36 months of age. Test sensitivity declined when RSV infection was accompanied by infection with other respiratory viruses.
CONCLUSIONS
Binax NOW RSV exhibited good diagnostic performance, easy handling, and rapidity. However, it does have the possibility of false-negative results, and additional tests are needed when there is clinical suspicion of RSV infection.

Keyword

Respiratory syncytial virus; Rapid antigen; Multiplex reverse transcription-PCR

MeSH Terms

Child
Humans
Respiratory Syncytial Viruses*
Respiratory Tract Infections
Sensitivity and Specificity

Reference

1. Simoes EA. Respiratory syncytial virus infection. Lancet. 1999; 354:847–852.

2. Miernyk K, Bulkow L, DeByle C, Chikoyak L, Hummel KB, Hennessy T, et al. Performance of a rapid antigen test (Binax NOW® RSV) for diagnosis of respiratory syncytial virus compared with real-time polymerase chain reaction in a pediatric population. J Clin Virol. 2011; 50:240–243.

3. Kim MR, Lee HR, Lee GM. Epidemiology of acute viral respiratory tract infections in Korean children. J Infect. 2000; 41:152–158.

4. Kim SH, Huh JH, Bae SY, Kim JS, Yoon SY, Lim CS, et al. Epidemiology of respiratory viral infection in 2004-2006. Korean J Lab Med. 2006; 26:351–357.

5. Henrickson KJ. Advances in the laboratory diagnosis of viral respiratory disease. Pediatr Infect Dis J. 2004; 23:1 Suppl. S6–S10.

6. Stockton J, Ellis JS, Saville M, Clewley JP, Zambon MC. Multiplex PCR for typing and subtyping influenza and respiratory syncytial viruses. J Clin Microbiol. 1998; 36:2990–2995.

7. Petric M, Comanor L, Petti CA. Role of the laboratory in diagnosis of influenza during seasonal epidemics and potential pandemics. J Infect Dis. 2006; 194:Suppl 2. S98–S110.

8. Jennings LC, Anderson TP, Werno AM, Beynon KA, Murdoch DR. Viral etiology of acute respiratory tract infections in children presenting to hospital: role of polymerase chain reaction and demonstration of multiple infections. Pediatr Infect Dis J. 2004; 23:1003–1007.

9. Mohapatra SS, Boyaplle S. Epidemiologic, experimental, and clinical links between respiratory syncytial virus infection and asthma. Clin Microbiol Rev. 2008; 21:495–594.

10. Sidwell RW, Barnard DL. Respiratory syncytial virus infections: recent prospects for control. Antiviral Res. 2006; 71:379–390.

11. Halstead DC, Todd S, Fritch G. Evaluation of five methods for respiratory syncytial virus detection. J Clin Microbiol. 1990; 28:1021–1025.

12. Henrickson KJ, Hall CB. Diagnostic assays for respiratory syncytial virus disease. Pediatr Infect Dis J. 2007; 26:11 Suppl. S36–S40.

13. Freymuth F, Vabret A, Cuvillon-Nimal D, Simon S, Dina J, Legrand L, et al. Comparison of multiplex PCR assays and conventional techniques for the diagnostic of respiratory virus infections in children admitted to hospital with an acute respiratory illness. J Med Virol. 2006; 78:1498–1504.

14. Barenfanger J, Drake C, Leon N, Mueller T, Troutt T. Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000; 38:2824–2828.

15. Ohm-Smith MJ, Nassos PS, Haller BL. Evaluation of the Binax NOW, BD Directigen, and BD Directigen EZ assays for detection of respiratory syncytial virus. J Clin Microbiol. 2004; 42:2996–2999.

16. Zheng X, Quianzon S, Mu Y, Katz BZ. Comparison of two new rapid antigen detection assays for respiratory syncytial virus with another assay and shell vial culture. J Clin Virol. 2004; 31:130–133.

17. Borek AP, Clemens SH, Gaskins VK, Aird DZ, Valsamakis A. Respiratory syncytial virus detection by Remel Xpect, Binax Now RSV, direct immunofluorescent staining, and tissue culture. J Clin Microbiol. 2006; 44:1105–1107.

18. Cruz AT, Cazacu AC, Greer JM, Demmler GJ. Performance of a rapid assay (Binax NOW) for detection of respiratory syncytial virus at a children's hospital over a 3-year period. J Clin Microbiol. 2007; 45:1993–1995.

19. Liao RS, Tomalty LL, Majury A, Zoutman DE. Comparison of viral isolation and multiplex real-time reverse transcription-PCR for confirmation of respiratory syncytial virus and influenza virus detection by antigen immunoassays. J Clin Microbiol. 2009; 47:527–532.

20. Aldous WK, Gerber K, Taggart EW, Thomas J, Tidwell D, Daly JA. A comparison of Binax NOW to viral culture and direct fluorescent assay testing for respiratory syncytial virus. Diagn Microbiol Infect Dis. 2004; 49:265–268.

21. Jonathan N. Diagnostic utility of BINAX NOW RSV an evaluation of the diagnostic performance of BINAX NOW RSV in comparison with cell culture and direct immunofluorescence. Ann Clin Microbiol Antimicrob. 2006; 5:13.