title: Evaluation and verification of the nanosphere Verigene RV+ assay for detection of influenza A/B and H1/H3 subtyping.
abstract: With the emerging risks of drug-resistant viruses and pandemic influenza, rapid and accurate detection of influenza viruses and determination of their subtypes is a crucial component of patient management. This study evaluated the performance of the Verigene respiratory virus plus nucleic acid (Verigene RV+) test for the detection of influenza A/B and subtype determination compared it with conventional molecular methods. Nasopharyngeal swabs were collected from 228 patients with influenza-like illness (influenza A (n = 67), 2009-H1N1 (n = 21), influenza B (n = 80), mixed A & B (n = 3), mixed RSV A and influenza (n = 3), and influenza-negative (n = 54)). Patient samples were analyzed by Influenza A/B one-step typing (Seegene, Seoul, Korea), Seeplex RV15 ACE Detection (Seegene), Nanosphere Verigene RV+ assay (Nanosphere, Northbrrook, IL) and virus culture. Out of 228 samples, 109 (47.8%) were positive by culture, and an additional 65 (28.5%) were positive by Seeplex RV15 ACE Detection, Influenza A/B one-step typing or Nanosphere Verigene RV+ assay. In comparison tests with Seeplex RV15 ACE Detection RT-PCR, the sensitivity of the Verigene RV+ kit for detection of the influenza A, 2009-H1N1, influenza B, and mixed A & B was 97.1%, 100%, 100%, and 100%, respectively. The specificity of the Verigene RV+ was 100% for all types. The concordance between Verigene RV+ and Influenza A/B one-step typing for H1, H3, H1/H3 mixed, and 2009-H1N1 was 100% (26/26), 100% (35/35), 100% (4/4), and 100% (21/21), respectively. The Verigene RV+ assay showed acceptable sensitivity and specificity for detection and subtyping of influenza viruses compared with the conventional RT-PCR method. J. Med. Virol. 87: 18-24, 2015. © 2014 Wiley Periodicals, Inc.
authors.affiliation: Department of Emergency Medicine, Korea University, Seoul, Republic of Korea.
authors.forename: Han Jin
authors.initials: HJ
authors.lastname: Cho
authors.forename: Jin Woo
authors.initials: JW
authors.lastname: Jang
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Ko
authors.forename: Sung Hyuk
authors.initials: SH
authors.lastname: Choi
authors.forename: Chae Seung
authors.initials: CS
authors.lastname: Lim
authors.forename: Seong Soo A
authors.initials: SS
authors.lastname: An
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D005260:Female; D060005:Genotyping Techniques / Q000379:methods; D006801:Humans; D007223:Infant; D009980:Influenza A virus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D009981:Influenza B virus / Q000235:genetics / Q000302:isolation & purification*; D007251:Influenza, Human / Q000175:diagnosis* / Q000821:virology*; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D054118:Nanospheres; D009305:Nasopharynx / Q000821:virology; D012680:Sensitivity and Specificity; D055815:Young Adult
keywords: diagnostic; influenza; molecular