Comparative evaluation of the CerTest VIASURE flu A, B & RSV real time RT-PCR detection kit on the BD MAX system versus a routine in-house assay for detection of influenza A and B virus during the 2016/17 influenza season

Thomas Vognbjerg Sydenham, Malene Bek-Thomsen, Signe Dalsgaard Andersen, Birte Kolmos, Ea Sofie Marmolin, Ramona Trebbien, Jens Kjølseth Møller

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Resumé

BACKGROUND: Diagnosing of influenza rapidly and accurately helps clinicians to initiate appropriate treatment options and isolation protocols. Unnecessary antimicrobial treatment and laboratory testing can also be reduced. Assess commercial alternatives to in-house assays that may not only reduce laboratory technician "hands on" time but also the laboratory turnaround time is of interest.

OBJECTIVES: We evaluated the performance of the VIASURE Flu A, B & RSV Real Time RT-PCR Detection Kit (CerTest Biotec) for detecting Influenza A and B viruses.

STUDY DESIGN: During the 2016/17 influenza season 532 clinical samples were tested with the VIASURE assay on the BD MAX™ system versus an in-house real time RT-PCR assay with discrepant results resolved by a real time RT-PCR assay at a national reference laboratory.

RESULTS: The VIASURE assay on the BD MAX showed a sensitivity of 99.5% (95% CI: 97.3-100) and a specificity of 99.1% (95% CI: 97.4-99.8) for detection of Influenza A virus. The positive predictive and negative predictive values were 98.5% (95% CI: 95.8-99.7) and 99.7% (95% CI: 98.3-100) respectively. Influenza B virus detection could not be evaluated due to a low positivity rate. The BD MAX platform offered the flexibility of several daily runs, shorter hands-on-time and shorter turnaround time than the in-house assay.

CONCLUSIONS: The VIASURE assay on the BD MAX performed well and is now implemented in our clinical laboratory.

OriginalsprogEngelsk
TidsskriftJournal of Clinical Virology
Vol/bind99-100
Sider (fra-til)35-37
ISSN1386-6532
DOI
StatusUdgivet - 1. feb. 2018

Fingeraftryk

Influenza B virus
Influenza A virus
Human Influenza
Real-Time Polymerase Chain Reaction

Citer dette

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title = "Comparative evaluation of the CerTest VIASURE flu A, B & RSV real time RT-PCR detection kit on the BD MAX system versus a routine in-house assay for detection of influenza A and B virus during the 2016/17 influenza season",
abstract = "BACKGROUND: Diagnosing of influenza rapidly and accurately helps clinicians to initiate appropriate treatment options and isolation protocols. Unnecessary antimicrobial treatment and laboratory testing can also be reduced. Assess commercial alternatives to in-house assays that may not only reduce laboratory technician {"}hands on{"} time but also the laboratory turnaround time is of interest.OBJECTIVES: We evaluated the performance of the VIASURE Flu A, B & RSV Real Time RT-PCR Detection Kit (CerTest Biotec) for detecting Influenza A and B viruses.STUDY DESIGN: During the 2016/17 influenza season 532 clinical samples were tested with the VIASURE assay on the BD MAX™ system versus an in-house real time RT-PCR assay with discrepant results resolved by a real time RT-PCR assay at a national reference laboratory.RESULTS: The VIASURE assay on the BD MAX showed a sensitivity of 99.5{\%} (95{\%} CI: 97.3-100) and a specificity of 99.1{\%} (95{\%} CI: 97.4-99.8) for detection of Influenza A virus. The positive predictive and negative predictive values were 98.5{\%} (95{\%} CI: 95.8-99.7) and 99.7{\%} (95{\%} CI: 98.3-100) respectively. Influenza B virus detection could not be evaluated due to a low positivity rate. The BD MAX platform offered the flexibility of several daily runs, shorter hands-on-time and shorter turnaround time than the in-house assay.CONCLUSIONS: The VIASURE assay on the BD MAX performed well and is now implemented in our clinical laboratory.",
keywords = "Commercial assay, Influenza, Molecular diagnostics, Respiratory",
author = "Sydenham, {Thomas Vognbjerg} and Malene Bek-Thomsen and Andersen, {Signe Dalsgaard} and Birte Kolmos and Marmolin, {Ea Sofie} and Ramona Trebbien and M{\o}ller, {Jens Kj{\o}lseth}",
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year = "2018",
month = "2",
day = "1",
doi = "10.1016/j.jcv.2017.12.010",
language = "English",
volume = "99-100",
pages = "35--37",
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Comparative evaluation of the CerTest VIASURE flu A, B & RSV real time RT-PCR detection kit on the BD MAX system versus a routine in-house assay for detection of influenza A and B virus during the 2016/17 influenza season. / Sydenham, Thomas Vognbjerg; Bek-Thomsen, Malene; Andersen, Signe Dalsgaard; Kolmos, Birte; Marmolin, Ea Sofie; Trebbien, Ramona; Møller, Jens Kjølseth.

I: Journal of Clinical Virology, Bind 99-100, 01.02.2018, s. 35-37.

Publikation: Bidrag til tidsskriftLetterForskningpeer review

TY - JOUR

T1 - Comparative evaluation of the CerTest VIASURE flu A, B & RSV real time RT-PCR detection kit on the BD MAX system versus a routine in-house assay for detection of influenza A and B virus during the 2016/17 influenza season

AU - Sydenham, Thomas Vognbjerg

AU - Bek-Thomsen, Malene

AU - Andersen, Signe Dalsgaard

AU - Kolmos, Birte

AU - Marmolin, Ea Sofie

AU - Trebbien, Ramona

AU - Møller, Jens Kjølseth

N1 - Copyright © 2017 Elsevier B.V. All rights reserved.

PY - 2018/2/1

Y1 - 2018/2/1

N2 - BACKGROUND: Diagnosing of influenza rapidly and accurately helps clinicians to initiate appropriate treatment options and isolation protocols. Unnecessary antimicrobial treatment and laboratory testing can also be reduced. Assess commercial alternatives to in-house assays that may not only reduce laboratory technician "hands on" time but also the laboratory turnaround time is of interest.OBJECTIVES: We evaluated the performance of the VIASURE Flu A, B & RSV Real Time RT-PCR Detection Kit (CerTest Biotec) for detecting Influenza A and B viruses.STUDY DESIGN: During the 2016/17 influenza season 532 clinical samples were tested with the VIASURE assay on the BD MAX™ system versus an in-house real time RT-PCR assay with discrepant results resolved by a real time RT-PCR assay at a national reference laboratory.RESULTS: The VIASURE assay on the BD MAX showed a sensitivity of 99.5% (95% CI: 97.3-100) and a specificity of 99.1% (95% CI: 97.4-99.8) for detection of Influenza A virus. The positive predictive and negative predictive values were 98.5% (95% CI: 95.8-99.7) and 99.7% (95% CI: 98.3-100) respectively. Influenza B virus detection could not be evaluated due to a low positivity rate. The BD MAX platform offered the flexibility of several daily runs, shorter hands-on-time and shorter turnaround time than the in-house assay.CONCLUSIONS: The VIASURE assay on the BD MAX performed well and is now implemented in our clinical laboratory.

AB - BACKGROUND: Diagnosing of influenza rapidly and accurately helps clinicians to initiate appropriate treatment options and isolation protocols. Unnecessary antimicrobial treatment and laboratory testing can also be reduced. Assess commercial alternatives to in-house assays that may not only reduce laboratory technician "hands on" time but also the laboratory turnaround time is of interest.OBJECTIVES: We evaluated the performance of the VIASURE Flu A, B & RSV Real Time RT-PCR Detection Kit (CerTest Biotec) for detecting Influenza A and B viruses.STUDY DESIGN: During the 2016/17 influenza season 532 clinical samples were tested with the VIASURE assay on the BD MAX™ system versus an in-house real time RT-PCR assay with discrepant results resolved by a real time RT-PCR assay at a national reference laboratory.RESULTS: The VIASURE assay on the BD MAX showed a sensitivity of 99.5% (95% CI: 97.3-100) and a specificity of 99.1% (95% CI: 97.4-99.8) for detection of Influenza A virus. The positive predictive and negative predictive values were 98.5% (95% CI: 95.8-99.7) and 99.7% (95% CI: 98.3-100) respectively. Influenza B virus detection could not be evaluated due to a low positivity rate. The BD MAX platform offered the flexibility of several daily runs, shorter hands-on-time and shorter turnaround time than the in-house assay.CONCLUSIONS: The VIASURE assay on the BD MAX performed well and is now implemented in our clinical laboratory.

KW - Commercial assay

KW - Influenza

KW - Molecular diagnostics

KW - Respiratory

U2 - 10.1016/j.jcv.2017.12.010

DO - 10.1016/j.jcv.2017.12.010

M3 - Letter

VL - 99-100

SP - 35

EP - 37

JO - Journal of Clinical Virology

JF - Journal of Clinical Virology

SN - 1386-6532

ER -