Evaluation and verification of the nanosphere Verigene RV+ assay for detection of influenza A/B and H1/H3 subtyping. Issue 1 (5th May 2014) - Cho, Han Jin
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.