Evaluation and verification of the nanosphere Verigene RV+ assay for detection of influenza A/B and H1/H3 subtyping

Han Jin Cho, Jin Woo Jang, Sun-Young Ko, Sung Hyuk Choi, Chae Seung Lim, Seong Soo A An

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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.

Original languageEnglish
Pages (from-to)18-24
Number of pages7
JournalJournal of Medical Virology
Volume87
Issue number1
DOIs
Publication statusPublished - 2014 Jan 1

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Nanospheres
Human Influenza
Orthomyxoviridae
Viruses
Polymerase Chain Reaction
Pandemics
Korea
Nucleic Acids

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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.",
keywords = "Diagnostic, Influenza, Molecular",
author = "Cho, {Han Jin} and Jang, {Jin Woo} and Sun-Young Ko and Choi, {Sung Hyuk} and Lim, {Chae Seung} and An, {Seong Soo A}",
year = "2014",
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T1 - Evaluation and verification of the nanosphere Verigene RV+ assay for detection of influenza A/B and H1/H3 subtyping

AU - Cho, Han Jin

AU - Jang, Jin Woo

AU - Ko, Sun-Young

AU - Choi, Sung Hyuk

AU - Lim, Chae Seung

AU - An, Seong Soo A

PY - 2014/1/1

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N2 - 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.

AB - 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.

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KW - Influenza

KW - Molecular

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