Multicenter evaluation of the Alere™ i influenza A&B assay using respiratory specimens collected in viral transport media

Diagnostic Microbiology and Infectious Disease

Volumn 92, Issue 4, 2018, Pages 294-298

  Hassan, Ferdaus ^a   Crawford, Jordan ^a   Bonner, Aleta B ^b   Ledeboer, Nathan A ^c   Selvarangan, Rangaraj ^a  

^a CHILDREN S MERCY HOSPITAL   (United States)

^b PA   (United States)

^c MEDICAL COLLEGE OF WISCONSIN   (United States)

Author keywords

Alere i Influenza A B assay; Clinical trial; Influenza virus; Molecular method; Point of care testing; Turn around time

Indexed keywords

ADULT; ALERE I INFLUENZA A AND B ASSAY; ARTICLE; ASSAY; CHILD; CONTROLLED STUDY; DIAGNOSTIC TEST ACCURACY STUDY; EXTRACTION; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; HUMAN; INFLUENZA A VIRUS; INFLUENZA B VIRUS; MULTICENTER STUDY; NASOPHARYNX; NONHUMAN; NUCLEIC ACID AMPLIFICATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; UNITED STATES; VIRUS DETECTION; CLASSIFICATION; CLINICAL TRIAL; DIAGNOSTIC KIT; GENETICS; INFLUENZA; ISOLATION AND PURIFICATION; MOLECULAR TYPING; POINT OF CARE TESTING; PROCEDURES; REAL TIME POLYMERASE CHAIN REACTION; VIROLOGY;

HUMANS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; INFLUENZA, HUMAN; MOLECULAR TYPING; POINT-OF-CARE TESTING; REAGENT KITS, DIAGNOSTIC; REAL-TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY;

EID: 85050811176     PISSN: 07328893     EISSN: 18790070     Source Type: Journal    
DOI: 10.1016/j.diagmicrobio.2018.07.002     Document Type: Article

References (25)

1. Atmar, R.L., Lindstrom, S.E., Influenza viruses. Jorgersen, J.H., Pfaller, M.A., Carroll, K.C., Landry, M.L., Funke, G., Richter, S.S., Warnock, D.W., (eds.), 11th ed. Manual of clinical microbiology, vol. 2, 2015, ASM Press, Washington, DC, 1470–1486.
2. 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 38 (2000), 2824–2828.
3. Bell, J.J., Selvarangan, R., Evaluation of the Alere I influenza a&B nucleic acid amplification test by use of respiratory specimens collected in viral transport medium. J Clin Microbiol 52 (2014), 3992–3995.
4. Bonner, A.B., Monroe, K.W., Talley, L.I., Klasner, A.E., Kimberlin, D.W., Impact of the rapid diagnosis of influenza on physician decision-making and patient management in the pediatric emergency department: results of a randomized, prospective, controlled trial. Pediatrics 112 (2003), 363–367.
5. Busson, L., Mahadeb, B., De Foor, M., Vandenberg, O., Hallin, M., Contribution of a rapid influenza diagnostic test to manage hospitalized patients with suspected influenza. Diagn Microbiol Infect Dis 87 (2017), 238–242.
6. Byington, C.L., Castillo, H., Gerber, K., Daly, J.A., Brimley, L.A., Adams, S., et al. The effect of rapid respiratory viral diagnostic testing on antibiotic use in a children's hospital. Arch Pediatr Adolesc Med 156 (2002), 1230–1234.
7. Chapin, K.C., Flores-Cortez, E.J., Performance of the molecular Alere I influenza a&B test compared to that of the xpert flu a/B assay. J Clin Microbiol 53 (2015), 706–709.
8. Chiarella, F.C., Culebras, E., Fuentes-Ferrer, M.E., Picazo, J.J., Evaluation of the Alere i influenza a&B assay for rapid identification of influenza a and influenza B viruses. J Med Microbiol 65 (2016), 456–461.
9. Dunn, J.J., Ginocchio, C.C., Can newly developed, rapid immunochromatographic antigen detection tests be reliably used for the laboratory diagnosis of influenza virus infections?. J Clin Microbiol 53 (2015), 1790–1796.
10. Food and Drug Administration (FDA), Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens. https://www.federalregister.gov/documents/2017/01/12/2017-00199/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for [Last accessed on Jan 19th, 2018].
11. Hassan, F., Nguyen, A., Formanek, A., Bell, J.J., Selvarangan, R., Comparison of the BD Veritor system for flu a+B with the Alere BinaxNOW influenza a&B card for detection of influenza a and B viruses in respiratory specimens from pediatric patients. J Clin Microbiol 52 (2014), 906–910.
12. Hazelton, B., Gray, T., Ho, J., Ratnamohan, V.M., Dwyer, D.E., Kok, J., Detection of influenza a and B with the Alere ™ i influenza a&B: a novel isothermal nucleic acid amplification assay. Influenza Other Respir Viruses 9 (2015), 151–154.
13. Hymas, W.C., Hillyard, D.R., Evaluation of Nanogen MGB alert detection reagents in a multiplex real-time PCR for influenza virus types a and B and respiratory syncytial virus. J Virol Methods 156 (2009), 124–128.
14. Ko, F., Drews, S.J., The impact of commercial rapid respiratory virus diagnostic tests on patient outcomes and health system utilization. Expert Rev Mol Diagn 17 (2017), 917–931.
15. Legoff, J., Kara, R., Moulin, F., Si-Mohamed, A., Krivine, A., Bélec, 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 46 (2008), 789–791.
16. Li, H., McCormac, M.A., Estes, R.W., Sefers, S.E., Dare, R.K., Chappell, J.D., et al. Simultaneous detection and high-throughput identification of a panel of RNA viruses causing respiratory tract infections. J Clin Microbiol 45 (2007), 2105–2109.
17. MerckX, J., Wali, R., Schiller, I., Caya, C., Gore, G.C., Chartrand, C., et al. Diagnostic accuracy of novel and traditional rapid tests for Inluenza infection compared with reverse transcriptase polymerase chain reaction. Ann Intern Med 167 (2017), 394–409.
18. Rogers, B.B., Shankar, P., Jerris, R.C., Kotzbauer, D., Anderson, E.J., Watson, J.R., et al. Impact of a rapid respiratory panel test on patient outcomes. Arch Pathol Lab Med 139 (2014), 636–641.
19. Rolfes, M.A., Foppa, I.M., Garg, S., Flannery, B., Brammer, L., Singleton, J.A., et al. Estimated Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths Averted by Vaccination in the United States. Ctr Dis Control Prev, 2017 [Last accessed on Jun 20th, 2018].
20. Selvaraju, S.B., Wurst, M., Horvat, R.T., Selvarangan, R., Evaluation of three influenza a and B real-time reverse transcription-PCR assays and a new 2009 H1N1 assay for detection of influenza viruses. J Clin Microbiol 48 (2010), 3870–3875.
21. Soto, M., Sampietro-Colom, L., Vilella, A., Pantoja, E., Asenjo, M., Arjona, R., et al. Economic impact of a new rapid PCR assay for detecting influenza virus in an emergency department and hospitalized patients. PLoS One, 11(1), 2016, e0146620.
22. Stellrecht, K.A., The Drift in Molecular Testing for Influenza: Mutations Affecting Assay Performance. J Clin Microbiol, 22, 2018, 1531-17.
23. Stellrecht, K.A., Nattanmai, S.M., Butt, J., Maceira, V.P., Espino, A.A., Castro, A.J., et al. Effect of genomic drift of influenza PCR tests. J Clin Virol 93 (2017), 25–29.
24. van Elden, L.J., Nijhuis, M., Schipper, P., Schuurman, R., van Loon, A.M., Simultaneous detection of influenza viruses a and B using real-time quantitative PCR. J Clin Microbiol 39 (2001), 196–200.
25. Wishaupt, J.O., Russcher, A., Smeets, L.C., Versteegh, F.G., Hartwig, N.G., Clinical impact of RT-PCR for pediatric acute respiratory infections: a controlled clinical trial. Pediatrics 128 (2011), 1113–1120.