Abstract
The lack of sensitivity of rapid immunoassays in detecting the novel 2009 H1N1 influenza virus infection has led to recommendations on influenza diagnostic testing for clinicians treating patients as well as advising clinicians on testing decisions. Studies have also shown that rapid immunoassays for seasonal influenza virus show considerable variability in performance characteristics, based on age of patient, prevalence of disease, course of infection, and the quality of the kit used. While public health authorities are currently focused on influenza virus diagnostics, a lack of sensitivity of rapid immunoassays for other viral respiratory pathogens has been widely reported, such as the very limited value of rapid immunoassays for the detection of respiratory syncytial virus in adults. In light of the lack of sensitivity of diagnostic tests for suspected 2009 H1N1 influenza virus infection, as well as their variable performance characteristics for seasonal influenza virus, a number of recommendations have been made by public health authorities advising clinicians on the need for clinical judgment as an important part of testing and treatment decisions as well as reliance on local epidemiologic and surveillance data. With the availability of new molecular methodologies that are user-friendly and allow the front-line physician as well as hospital infection control programs to significantly improve respiratory viral diagnostics, there is a need to carefully determine the most optimal diagnostic testing methodology based on the clinical setting. This review will describe the historical, current, and changing dynamics of respiratory virus infection diagnostics.
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References
Mahony JB. Detection of respiratory viruses by molecular methods. Clin Microbiol Rev. 2008;21:716–47.
Epsy MJ, Smith TE, Harmon MW, Kendal AP. Rapid detection of influenza virus by shell vial assay with monoclonal antibodies. J Clin Microbiol. 1986;24:677–9.
Landry ML, Hsiung GD. Primary isolation of viruses. In: Spector S, Hodinka RL, Young SA, editors. Clinical virology manual. Washington: ASM; 2000, p. 27–29.
Atmar R. Influenza viruses. In: Murray PR, Baron EJ, Jorgensen J, Landry ML, Pfaller MA, editors. Manual of Clinical Microbiology. Washington: ASM; 2007, p. 1340–1351.
Tang YW, Crowe JE. Respiratory syncytial virus and human metapneumovirus. In: Murray PR, Baron EJ, Jorgensen J, Landry ML, Pfaller MA, editors. Manual of Clinical Microbiology. Washington: ASM; 2007, p. 1361–1377.
Ginocchio CC, Lotlikar M, Falk L, Arora S, Kowerska M, Bornfreund M, et al. Clinical performance of the 3M Rapid Detection Flu A+B Test compared to R-Mix culture, DFA and BinaxNOW Influenza A&B Test. J Clin Virol. 2009;45:146–7.
Kim JS, Kim SH, Bae SY, Lim CS, Kim YK, Lee KN, et al. Enhanced detection of respiratory viruses using cryopreserved R-Mix ReadyCells. J Clin Virol. 2008;42:264–7.
Landry ML, Ferguson D. SimulFluor respiratory screen for rapid detection of multiple respiratory viruses in clinical specimens by immunofluorescence staining. J Clin Microbiol. 2000;38:708–11.
Vinh DC, Newby D, Charest H, McDonald J. Evaluation of a commercial direct fluorescent-antibody assay for human metapneumovirus in respiratory specimens. J Clin Microbiol. 2008;46:1840–1.
Uyeki TM, Prasad R, Vukotich C, Stebbins S, Rinaldo CR, et al. Low sensitivity of rapid diagnostic test for influenza. CID. 2009;48:e89–92.
Ruef C. Diagnosing influenza—clinical assessment and/or rapid antigen testing? Infection. 2007;35:49–50.
Hurt AC, Alexander R, Hibbert J, Deed N, Barr IG. Performance of six influenza rapid tests in detecting human influenza in clinical specimens. J Clin Virol. 2007;39:132–5.
Chan KH, Lam SY, Puthavathana P, Nguyen TD, Long HT, et al. Comparative analytical sensitivities of six rapid influenza A antigen detection test kits for detection of influenza A subtypes H1N1, H3N2 and H5N1. J Clin Virol. 2007;38:169–71.
Cazacu AC, Demmler GJ, Neuman MA, Forbes BA, Chung S, Greer J, et al. Comparison of a new lateral-flow chromatographic membrane immunoassay to viral culture for rapid detection and differentiation of influenza A and B viruses in respiratory specimens. J Clin Microbiol. 2004;42:3661–4.
Hara M, Takao S, Fukuda S, Shimazu Y, Miyazaki K. Evaluation of three immunochromatographic kits for rapid detection of influenza virus A and B. Lab Med. 2008;39:603–6.
Mehlmann M, Bonner AB, Williams JV, Dankbar DM, Moor CL, Kuchta RD, et al. Comparison of the MChip to viral culture, reverse transcription-PCR, and the quick vue influenza A+B test for the rapid diagnosis of influenza. J Clin Microbiol. 2007;45:1234–7.
Ginocchio CC, Zhang F, Manji R, Arora S, Bornfreund M, Falk L, et al. Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak. J Clin Virol. 2009;45:191–5.
CDC. Evaluation of rapid influenza diagnostic tests for detection of novel influenza A (H1N1) virus—United States, 2009. MMWR Morb Mortal Wkly Rep. 2009;58:826–829.
Henrickson KJ, Hall CB. Diagnostic assays for respiratory syncytial virus disease. Pediatr Infect Dis J. 2007;26:S36–40.
Falsey AR, Walsh EE. Respiratory syncytial virus infection in adults. Clin Microbiol Rev. 2000;42:371–84.
Selvarangan R, Abel D, Hamilton M. Comparison of BD Directigen EZ RSV and Binax NOW RSV tests for rapid detection of respiratory syncytial virus from nasopharyngeal aspirates in a pediatric population. Diagn Microbiol Infect Dis. 2008;62:157–61.
Aslanzadeh J, Zheng X, Li H, Tetreault J, Ratkiewicz I, Meng S, et al. Prospective evaluation of rapid antigen tests for diagnosis of respiratory syncytial virus and human metapneumovirus infections. J Clin Microbiol. 2008;46:1682–5.
Casiano-Colon AE, Hulbert B, Mayer TK, Walsh EE, Falsey AR. Lack of sensitivity of rapid antigen tests for the diagnosis of respiratory syncytial virus infections in adults. J Clin Virol. 2003;28:169–74.
Ohm-Smith MJ, Nassos PS, Haller BL. Evaluation of the Binax NOW 2004 BD Directigen, and BD Directigen EZ assays for detection of respiratory syncytial virus. J Clin Microbiol. 2004;42:2996–9.
Griffin MR, Walker FJ, Iwane MK, Weinburg GA, Staat MA, Erdman DD. Epidemiology of respiratory infections in young children: insights from the new vaccine surveillance network. Pediatr Infect Dis J. 2004;23:S188–92.
Chiu CY, Rouskin S, Koshy A, Urisman A, Fischer K, Yagi S, et al. Microarray detection of human parainfluenzavirus 4 infection associated with respiratory failure in an immunocompetent adult. Clin Infect Dis. 2006;43:71–6.
Matsuzaki Y, Takashita E, Okamoto M, Mizuta K, Itagaki T, Katsushima F, et al. Evaluation of a new rapid antigen test using immunochromatography for detection of human metapneumvirus in comparison with real-time PCR assay. J Clin Microbiol. 2009;47:2981–4.
Kikuta H, Sakata C, Gamo R, Ishizaka A, Koga Y, Konno M, et al. Comparison of a lateral-flow immunochromatography assay with real-time reverse transcription-PCR for detection of human metapneumovirus. J Clin Microbiol. 2009;46:928–32.
Kukavica-Ibrulj I, Bolvin G. Detection of human metapneumovirus antigens in nasopharyngeal aspirates using an enzyme immunoassay. J Clin Virol. 2009;44:88–90.
LeGoff J, Kara R, Moulin F, Si-Mohamed A, Krivine A, Belec L, et al. Evaluation of the one-step multiplex real-time reverse-transcription-PCR ProFlu-1 assay for detection of influenza A and influenza B viruses and respiratory syncytial viruses in children. J Clin Microbiol. 2008;46:789–91.
Nolte FS, Marshall DJ, Rasberry C, Schievelbein S, Banks GG, Storch GA, et al. MultiCode-PLx system for multiplexed detection of seventeen respiratory viruses. J Clin Microbiol. 2007;45:2779–86.
Takahashi H, Patterson BK. Evaluation of the NanoChip 400 for detection of influenza A and B, respiratory syncytial, and parainfluenza viruses. J Clin Microbiol. 2008;46:1724–7.
Roche Laboratories, Inc. Tamiflu safety information. http://www.tamiflu.com/isi.aspx. Last accessed 5 Feb 2010.
Lefferts JA, et al. Evaluation of the Nanosphere Verigene® System and the Verigene®F5/F2/MTHFR Nucleic Acid Tests. Exp Mol Pathol. 2009;87:105–8.
Jannetto, PJ, Vaughan K, Prokhorova A, Brener D, Lonosky PM, et al. Nanoparticle probes for detection and discrimination of influenza A/B and RSV A/B in respiratory specimens (Abstract M10 2009). In: 25th Clinical Virology Symp, Daytona Beach, FL, USA, 19–22 April 2009.
Ledeboer, N. Real-time random access respiratory virus testing (presentation). In: 109th American Soc Microbiology General Meeting, Philadelphia, PA, USA, 17–21 May 2009.
Sails AD, Saunders D, Airs S, Roberts D, Eltringham G, Magee JG. Evaluation of the cepheid respiratory syncytial virus and influenza virus A/B real-time PCR analyte specific reagent. J Virol Methods. 2009;156:124–8.
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Takahashi, H., Otsuka, Y. & Patterson, B.K. Diagnostic tests for influenza and other respiratory viruses: determining performance specifications based on clinical setting. J Infect Chemother 16, 155–161 (2010). https://doi.org/10.1007/s10156-010-0035-y
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DOI: https://doi.org/10.1007/s10156-010-0035-y