Multicenter clinical evaluation of the novel Alere™ i Influenza A&B isothermal nucleic acid amplification test

Journal of Clinical Virology

Volumn 61, Issue 1, 2014, Pages 81-86

  Bell, Jeremiah ^a,b   Bonner, Aleta ^c   Cohen, Daniel M ^d   Birkhahn, Robert ^e   Yogev, Ram ^f   Triner, Wayne ^g   Cohen, Jason ^g   Palavecino, Elizabeth ^h   Selvarangan, Rangaraj ^a,b  

^a CHILDREN S MERCY HOSPITAL   (United States)

^b UNIVERSITY OF MISSOURI KANSAS CITY SCHOOL OF MEDICINE   (United States)

^c Veritas PA   (United States)

^d OHIO STATE UNIVERSITY   (United States)

^e NEW YORK METHODIST HOSPITAL   (United States)

^f CHILDREN'S MEMORIAL HOSPITAL   (United States)

^g ALBANY MEDICAL COLLEGE   (United States)

^h WAKE FOREST BAPTIST HEALTH   (United States)

Author keywords

Alere i Influenza; Influenza; Nucleic acid amplification; POC; RADT

Indexed keywords

ADOLESCENT; ADULT; AGED; ARTICLE; CHILD; CLINICAL EVALUATION; CLINICAL STUDY; DIAGNOSTIC TEST ACCURACY STUDY; FALSE POSITIVE RESULT; FEMALE; HUMAN; INFANT; INFLUENZA A; INFLUENZA B; INFLUENZA VIRUS A; INFLUENZA VIRUS B; ISOTHERMAL NUCLEIC ACID AMPLIFICATION TEST; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NUCLEIC ACID ANALYSIS; POINT OF CARE TESTING; PRIORITY JOURNAL; PROSPECTIVE STUDY; REAL TIME POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY; VIRUS CULTURE; VIRUS DETECTION; CLINICAL TRIAL; EVALUATION STUDY; GENETICS; INFLUENZA, HUMAN; ISOLATION AND PURIFICATION; MIDDLE AGED; MOLECULAR DIAGNOSIS; NUCLEIC ACID AMPLIFICATION; PRESCHOOL CHILD; PROCEDURES; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; INFLUENZA A VIRUS; INFLUENZA B VIRUS; INFLUENZA, HUMAN; MALE; MIDDLE AGED; MOLECULAR DIAGNOSTIC TECHNIQUES; NUCLEIC ACID AMPLIFICATION TECHNIQUES; PROSPECTIVE STUDIES; YOUNG ADULT;

EID: 84905125251     PISSN: 13866532     EISSN: 18735967     Source Type: Journal    
DOI: 10.1016/j.jcv.2014.06.001     Document Type: Article

References (33)

1. Labella A.M., Merel S.E. Influenza. Med Clin North Am 2013, 97:621-645.
2. Peltola V., Reunanen T., Ziegler T., Silvennoinen H., Heikkinen T. Accuracy of clinical diagnosis of influenza in outpatient children. Clin Infect Dis 2005, 41:1198-1200.
3. Falsey A.R., Cunningham C.K., Barker W.H., Kouides R.W., Yuen J.B., Menegus M., et al. Respiratory syncytial virus and influenza A infections in the hospitalized elderly. J Infect Dis 1995, 172:389-394.
4. Neuzil K.M., Wright P.F., Mitchel E., Griffin M.R. The burden of influenza illness in children with asthma and other chronic medical conditions. J Pediatr 2000, 137:856-864.
5. Pitman R.J., Melegaro A., Gelb D., Siddiqui M.R., Gay N.J., Edmunds W.J. Assessing the burden of influenza and other respiratory infections in England and Wales. J Infect 2007, 54:530-538.
6. Thompson W.W., Shay D.K., Weintraub E., Brammer L., Cox N., Anderson L.J., et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003, 289:179-186.
7. Welliver R.C. Respiratory syncytial virus, other respiratory viruses. Pediatr Infect Dis J 2003, 22:S6-S10. Discussion S10-2.
8. Garbino J., Gerbase M.W., Wunderli W., Deffernez C., Thomas Y., Rochat T., et al. Lower respiratory viral illnesses: improved diagnosis by molecular methods and clinical impact. Am J Respir Crit Care Med 2004, 170:1197-1203.
9. Jennings L.C., Anderson T.P., Werno A.M., Beynon K.A., Murdoch D.R. 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.
10. Lee B.E., Robinson J.L., Khurana V., Pang X.L., Preiksaitis J.K., Fox J.D. Enhanced identification of viral and atypical bacterial pathogens in lower respiratory tract samples with nucleic acid amplification tests. J Med Virol 2006, 78:702-710.
11. Lee N., Chan P.K., Hui D.S., Rainer T.H., Wong E., Choi K.W., et al. Viral loads and duration of viral shedding in adult patients hospitalized with influenza. J Infect Dis 2009, 200:492-500.
12. Molinari N.A., Ortega-Sanchez I.R., Messonnier M.L., Thompson W.W., Wortley P.M., Weintraub E., et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine 2007, 25:5086-5096.
13. Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med 2005, 353:1363-1373.
14. Borek A.P., Clemens S.H., Gaskins V.K., Aird D.Z., 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.
15. Gardner P.S. Rapid diagnostic techniques in clinical virology. Mod Trends Med Virol 1970, 2:15-50.
16. Ohm-Smith M.J., Nassos P.S., Haller B.L. 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.
17. Ribes J.A., Seabolt J.P., Overman S.B. Performance characteristics of VIDAS and directigen respiratory syncytial virus (RSV) antigen detection assays and culture for the identification of RSV in respiratory specimens. J Clin Microbiol 2002, 40:1818-1820.
18. van Elden L.J., van Loon A.M., van der Beek A., Hendriksen K.A., Hoepelman A.I., van Kraaij M.G., et al. Applicability of a real-time quantitative PCR assay for diagnosis of respiratory syncytial virus infection in immunocompromised adults. J Clin Microbiol 2003, 41:4378-4381.
19. Weinberg G.A., Erdman D.D., Edwards K.M., Hall C.B., Walker F.J., Griffin M.R., et al. Superiority of reverse-transcription polymerase chain reaction to conventional viral culture in the diagnosis of acute respiratory tract infections in children. J Infect Dis 2004, 189:706-710.
20. Casiano-Colon A.E., Hulbert B.B., Mayer T.K., Walsh E.E., Falsey A.R. Lack of sensitivity of rapid antigen tests for the diagnosis of respiratory syncytial virus infection in adults. J Clin Virol 2003, 28:169-174.
21. Sidoti F., Bergallo M., Costa C., Cavallo R. Alternative molecular tests for virological diagnosis. Mol Biotechnol 2013, 53:352-362.
22. Ahmad F., Hashsham S.A. Miniaturized nucleic acid amplification systems for rapid and point-of-care diagnostics: a review. Anal Chim Acta 2012, 733:1-15.
23. Chang C.C., Chen C.C., Wei S.C., Lu H.H., Liang Y.H., Lin C.W. Diagnostic devices for isothermal nucleic acid amplification. Sensors (Basel) 2012, 12:8319-8337.
24. Lemieux B., Li Y., Kong H., Tang T.W. Near instrument-free, simple molecular device for rapid detection of herpes simplex viruses. Expert Rev Mol Diagn 2012, 12:437-443.
25. Sakurai A., Shibasaki F. Updated values for molecular diagnosis for highly pathogenic avian influenza virus. Viruses 2012, 4:1235-1257.
26. Mahony J., Chong S., Bulir D., Ruyter A., Mwawasi K., Waltho D., et al. Multiplex loop-mediated isothermal amplification (M-LAMP) assay for the detection of influenza A/H1, A/H3 and influenza B can provide a specimen-to-result diagnosis in 40 min with single genome copy sensitivity. J Clin Virol 2013, 58:127-131.
27. Wu L.T., Thomas I., Curran M.D., Ellis J.S., Parmar S., Goel N., et al. Duplex molecular assay intended for point-of-care diagnosis of influenza A/B virus infection. J Clin Microbiol 2013, 51:3031-3038.
28. Forman M.S., Valsamakis A. Specimen collection, transport, and processing: virology. Manual of clinical microbiology 2011, vol. 2:1276-1288. ASM Press, Washington, DC. 10th ed.
29. Esposito S., Molteni C.G., Daleno C., Valzano A., Tagliabue C., Galeone C., et al. Collection by trained pediatricians or parents of mid-turbinate nasal flocked swabs for the detection of influenza viruses in childhood. Virol J 2010, 7:85.
30. Larios O.E., Coleman B.L., Drews S.J., Mazzulli T., Borgundvaag B., Green K., et al. Self-collected mid-turbinate swabs for the detection of respiratory viruses in adults with acute respiratory illnesses. PLoS ONE 2011, 6:e21335.
31. Heikkinen T., Marttila J., Salmi A.A., Ruuskanen O. Nasal swab versus nasopharyngeal aspirate for isolation of respiratory viruses. J Clin Microbiol 2002, 40:4337-4339.
32. Heikkinen T., Salmi A.A., Ruuskanen O. Comparative study of nasopharyngeal aspirate and nasal swab specimens for detection of influenza. BMJ 2001, 322:138.
33. Scansen K.A., Bonsu B.K., Stoner E., Mack K., Salamon D., Leber A., et al. Comparison of polyurethane foam to nylon flocked swabs for collection of secretions from the anterior nares in performance of a rapid influenza virus antigen test in a pediatric emergency department. J Clin Microbiol 2010, 48:852-856.