Diagnostic accuracy of the real-time PCR cobas® Liat® Influenza A/B assay and the Alere i Influenza A&B NEAR isothermal nucleic acid amplification assay for the detection of influenza using adult nasopharyngeal specimens

Journal of Clinical Virology

Volumn 94, Issue , 2017, Pages 86-90

  Young, Stephen ^a   Illescas, Patrick ^a   Nicasio, Joclin ^a   Sickler, Joanna Jackson ^b  

^a TRICORE REFERENCE LABORATORIES   (United States)

^b ROCHE MOLECULAR SYSTEMS   (United States)

Author keywords

Alere i Influenza A B assay; cobas Liat Influenza A B assay; Influenza virus infection; Point of care; Real time polymerase chain reaction

Indexed keywords

ADULT; ARTICLE; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; HUMAN; INFLUENZA A; INFLUENZA A RAPID TEST; INFLUENZA A VIRUS; INFLUENZA B; INFLUENZA B VIRUS; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; NONHUMAN; NOSE SMEAR; NUCLEIC ACID AMPLIFICATION; POINT OF CARE TESTING; POLYMERASE CHAIN REACTION SYSTEM; PRIORITY JOURNAL; REAL TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; TRANSPORT MEDIUM; VIRUS DETECTION; GENETICS; INFLUENZA; MOLECULAR DIAGNOSIS; NASOPHARYNX; POINT OF CARE SYSTEM; PROCEDURES; VIROLOGY;

HUMANS; INFLUENZA A VIRUS; INFLUENZA B VIRUS; INFLUENZA, HUMAN; MOLECULAR DIAGNOSTIC TECHNIQUES; NASOPHARYNX; NUCLEIC ACID AMPLIFICATION TECHNIQUES; POINT-OF-CARE SYSTEMS; REAL-TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY;

EID: 85026458959     PISSN: 13866532     EISSN: 18735967     Source Type: Journal    
DOI: 10.1016/j.jcv.2017.07.012     Document Type: Article

References (33)

1. Klepser, M.E., Socioeconomic impact of seasonal (epidemic) influenza and the role of over-the-counter medicines. Drugs 74:13 (2014), 1467–1479, 10.1007/s40265-014-0245-1.
2. Quandelacy, T.M., Viboud, C., Charu, V., Lipsitch, M., Goldstein, E., Age- and sex-related risk factors for influenza-associated mortality in the United States between 1997 and 2007. Am. J. Epidemiol. 179:2 (2014), 156–167, 10.1093/aje/kwt235.
3. Wong, K.K., Jain, S., Blanton, L., Dhara, R., Brammer, L., Fry, A.M., et al. Influenza-associated pediatric deaths in the United States, 2004–2012. Pediatrics 132:5 (2013), 796–804, 10.1542/peds.2013-1493.
4. Grohskopf, L.A., Sokolow, L.Z., Broder, K.R., Olsen, S.J., Karron, R.A., Jernigan, D.B., et al. Prevention and control of seasonal influenza with vaccines. MMWR Recomm. Rep. 65:5 (2016), 1–54, 10.15585/mmwr.rr6505a1.
5. Peters, T.R., Suerken, C.K., Snively, B.M., Winslow, J.E., Nadkarni, M.D., Kribbs, S.B., et al. Influenza testing, diagnosis, and treatment in the emergency department in 2009–2010 and 2010–2011. Acad. Emerg. Med. 20:8 (2013), 786–794, 10.1111/acem.12175.
6. Centers for Disease Control and Prevention, Influenza Signs and Symptoms and the Role of Laboratory Diagnostics. 2016 https://www.cdc.gov/flu/professionals/diagnosis/labrolesprocedures.htm (Accessed 12 July 2017).
7. Chartrand, C., Leeflang, M.M., Minion, J., Brewer, T., Pai, M., Accuracy of rapid influenza diagnostic tests: a meta-analysis. Ann. Intern. Med. 156:7 (2012), 500–511, 10.7326/0003-4819-156-7-201204030-00403.
8. ® Flu, Package Insert. For In Vitro Diagnostic Use. 2014, Cepheid, Sunnyvale, CA, USA.
9. BioFire Respiratory panel, 510(k) Substantial Equivalence Determination. Decision Summary. 2016, BioFire Diagnostics, LLC, Salt Lake City, UT, USA https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160068.pdf (Accessed 08 February 2017).
10. Hawkins, R.C., Laboratory turnaround time. Clin. Biochem. Rev. 28:4 (2007), 179–194.
11. Rewar, S., Mirdha, D., Rewar, P., Treatment and prevention of pandemic H1N1 influenza. Ann. Glob. Health 81:5 (2015), 645–653, 10.1016/j.aogh.2015.08.014.
12. Rolfes, M.A., Yousey-Hindes, K.M., Meek, J.I., Fry, A.M., Chaves, S.S., Respiratory viral testing and influenza antiviral prescriptions during hospitalization for acute respiratory illnesses. Open Forum Infect. Dis., 3(1), 2016, ofv216, 10.1093/ofid/ofv216.
13. Havers, F., Thaker, S., Clippard, J.R., Jackson, M., McLean, H.Q., Gaglani, M., et al. Use of influenza antiviral agents by ambulatory care clinicians during the 2012–2013 influenza season. Clin. Infect. Dis. 59:6 (2014), 774–782, 10.1093/cid/ciu422.
14. Costelloe, C., Metcalfe, C., Lovering, A., Mant, D., Hay, A.D., Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ, 340, 2010, c2096, 10.1136/bmj.c2096.
15. ® Influenza A/B, Package Insert. For In Vitro Diagnostic Use. 2014, Roche Molecular Systems, Inc., Marlborough, MA, USA.
16. Alere™ i, Influenza A&B Package Insert. 2015, Alere Scarborough, Inc., Scarborough, ME, USA.
17. ® Liat Influenza A and B tests for rapid detection of influenza virus infection. J. Clin. Microbiol. 54:11 (2016), 2763–2766, 10.1128/JCM.01586-16.
18. Binnicker, M.J., Espy, M.J., Irish, C.L., Vetter, E.A., Direct detection of influenza A and B viruses in less than 20 minutes using a commercially available rapid PCR assay. J. Clin. Microbiol. 53:7 (2015), 2353–2354, 10.1128/JCM.00791-15.
19. ® Influenza A/B assay for rapid PCR-based detection of influenza compared to Prodesse Proflu+ and viral culture. Eur. J. Microbiol. Immunol. (Bp) 5:4 (2015), 236–245, 10.1556/1886.2015.00046.
20. ® system. J. Med. Virol. 89:8 (2017), 1382–1386, 10.1002/jmv.24796.
21. ® Influenza A and B test with the FilmArray Respiratory Panel and the Prodesse ProFlu+/ProFAST+ assays for the detection of H3 influenza viruses circulatingin 2015. Poster presented at: The Clinical Virology Symposium, Daytona Beach, FL, 2015.
22. © Liat rapid Influenza A/B assay during influenza season: analysis of test performance and qualification on the impact of patient management in the emergency department setting. Poster presented at: The Clinical Virology Symposium, Daytona Beach, FL, 2015.
23. Bell, J., Bonner, A., Cohen, D.M., Birkhahn, R., Yogev, R., Triner, W., et al. Multicenter clinical evaluation of the novel Alere™ i Influenza A&B isothermal nucleic acid amplification test. J. Clin. Virol. 61:1 (2014), 81–86, 10.1016/j.jcv.2014.06.001.
24. 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. 52:11 (2014), 3992–3995, 10.1128/JCM.01639-14.
25. Jokela, P., Vuorinen, T., Waris, M., Manninen, R., Performance of the Alere i influenza A&B assay and mariPOC test for the rapid detection of influenza A and B viruses. J. Clin. Virol. 70 (2015), 72–76, 10.1016/j.jcv.2015.07.294.
26. 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 9:3 (2015), 151–154, 10.1111/irv.12303.
27. Nie, S., Roth, R.B., Stiles, J., Mikhlina, A., Lu, X., Tang, Y.W., et al. Evaluation of Alere i Influenza A&B for rapid detection of influenza viruses A and B. J. Clin. Microbiol. 52:9 (2014), 3339–3344, 10.1128/JCM.01132-14.
28. Nguyen Van, J.C., Caméléna, F., Dahoun, M., Pilmis, B., Mizrahi, A., Lourtet, J., et al. Prospective evaluation of the Alere i Influenza A&B nucleic acid amplification versus Xpert Flu/RSV. Diagn. Microbiol. Infect. Dis. 85:1 (2016), 19–22, 10.1016/j.diagmicrobio.2015.11.012.
29. 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. 53:2 (2015), 706–709, 10.1128/JCM.02783-14.
30. 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. 65:6 (2016), 456–461, 10.1099/jmm.0.000249.
31. Riazzo, C., Pérez-Ruiz, M., Sanbonmatsu-Gámez, S., Pedrosa-Corral, I., Gutiérrez-Fernández, J., Navarro-Marí, J.M., Analytical performance of the Alere™ i Influenza A&B assay for the rapid detection of influenza viruses. Enferm. Infecc. Microbiol. Clin., 2015, 10.1016/j.eimc.2015.10.006 pii S0213-005X(15)00378-X.
32. Popowitch, E.B., O'Neill, S.S., Miller, M.B., Comparison of the Biofire FilmArray RP, Genmark eSensor RVP, Luminex xTAG RVPv1, and Luminex xTAG RVP fast multiplex assays for detection of respiratory viruses. J. Clin. Microbiol. 51:5 (2013), 1528–1533, 10.1128/JCM.03368-12.
33. Alere™ i Influenza A&B. 510(k) Summary. 2016, Alere Scarborough, Inc., Scarborough, ME, USA https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163266.pdf (Accessed 12 July 2017).