Multi-center evaluation of the adenovirus R-gene US assay for the detection of adenovirus in respiratory samples

Ryhana Manji, Xiaotian Zheng, Anami Patel, Malgorzata Kowerska, Margaret Vossinas, Angela Drain, Kathleen M. Todd, Noel Lenny, John Devincenzo, Christine C. Ginocchio

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: Adenoviruses (AdV) cause a variety of upper and lower respiratory tract infections, with the potential for severe outcomes, especially in persons with immune suppression or other underlying diseases. The ADENOVIRUS US R-gene (AdV R-gene, Argene/bioMérieux) is a FDA cleared real-time PCR assay that utilizes primers and fluorescent probes that target a conserved region of the hexon gene and an internal control DNA. Objectives: This prospective multi-center study evaluated the clinical performance of AdV R-gene for AdV detection in respiratory specimens from symptomatic patients of all ages. Study design: Nucleic acids from nasopharyngeal washes/aspirates (NPW/A; n= 393) and NP flocked swabs (NPS, Copan) (n= 1183) were extracted using NucliSENS easyMAG (bioMérieux) and AdV R-gene PCR was performed using the SmartCycler (Cepheid). AdV R-gene results were compared to R-Mix culture (Quidel/Diagnostic Hybrids). For a subset of samples (n= 946) AdV R-gene and R-Mix results were also compared to A549 cell culture. Results: In first intention analysis for NPS the AdV R-gene positive percent agreement (PPA), and negative percent agreement (NPA) were 91.7% and 96.2%, respectively, and for NPW/A were 100% and 94.4%, respectively, compared to R-Mix culture. In second intention analysis, discordant samples only were tested with an AdV real-time PCR assay (Viracor-IBT Labs) and amplicon sequencing. For NPS, the sensitivity, specificity, PPV and NPV for AdV R-gene were 98.9%, 100%, 100%, and 99.9%, respectively and for R-Mix culture were 51.7%, 99.7%, 93.8%, and 96.3%, respectively. For NPW/A, the sensitivity, specificity, PPV and NPV for AdV R-gene were 100%, 99.7%, 97.6%, and 100%, respectively, and for R-Mix culture were 52.5%, 100%, 100%, and 94.9%, respectively. Overall, AdV was detected by AdV R-gene and R-Mix in 7.4% and 4.1% NPS, respectively, and in 10.7% and 5.3% NPW/A, respectively. Children 5. yr and younger had the highest rates of AdV infections. In a subset of specimens (n= 946) the sensitivity of AdV R-gene, R-Mix, and A549 cell culture were 95.0%, 55.4% and 66.3%. Conclusions: AdV R-gene is sensitive and specific for the detection of AdV in NPW/A and NPS samples. AdV R-gene is simple to use and provides a rapid time to results (within 2.5-3 h).

Original languageEnglish (US)
Pages (from-to)90-95
Number of pages6
JournalJournal of Clinical Virology
Volume60
Issue number2
DOIs
StatePublished - Jan 1 2014

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vpr Genes
Adenoviridae
Real-Time Polymerase Chain Reaction
Cell Culture Techniques
Adenoviridae Infections
Sensitivity and Specificity

All Science Journal Classification (ASJC) codes

  • Virology
  • Infectious Diseases

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Multi-center evaluation of the adenovirus R-gene US assay for the detection of adenovirus in respiratory samples. / Manji, Ryhana; Zheng, Xiaotian; Patel, Anami; Kowerska, Malgorzata; Vossinas, Margaret; Drain, Angela; Todd, Kathleen M.; Lenny, Noel; Devincenzo, John; Ginocchio, Christine C.

In: Journal of Clinical Virology, Vol. 60, No. 2, 01.01.2014, p. 90-95.

Research output: Contribution to journalArticle

Manji, R, Zheng, X, Patel, A, Kowerska, M, Vossinas, M, Drain, A, Todd, KM, Lenny, N, Devincenzo, J & Ginocchio, CC 2014, 'Multi-center evaluation of the adenovirus R-gene US assay for the detection of adenovirus in respiratory samples', Journal of Clinical Virology, vol. 60, no. 2, pp. 90-95. https://doi.org/10.1016/j.jcv.2014.03.014
Manji, Ryhana ; Zheng, Xiaotian ; Patel, Anami ; Kowerska, Malgorzata ; Vossinas, Margaret ; Drain, Angela ; Todd, Kathleen M. ; Lenny, Noel ; Devincenzo, John ; Ginocchio, Christine C. / Multi-center evaluation of the adenovirus R-gene US assay for the detection of adenovirus in respiratory samples. In: Journal of Clinical Virology. 2014 ; Vol. 60, No. 2. pp. 90-95.
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abstract = "Background: Adenoviruses (AdV) cause a variety of upper and lower respiratory tract infections, with the potential for severe outcomes, especially in persons with immune suppression or other underlying diseases. The ADENOVIRUS US R-gene (AdV R-gene, Argene/bioM{\'e}rieux) is a FDA cleared real-time PCR assay that utilizes primers and fluorescent probes that target a conserved region of the hexon gene and an internal control DNA. Objectives: This prospective multi-center study evaluated the clinical performance of AdV R-gene for AdV detection in respiratory specimens from symptomatic patients of all ages. Study design: Nucleic acids from nasopharyngeal washes/aspirates (NPW/A; n= 393) and NP flocked swabs (NPS, Copan) (n= 1183) were extracted using NucliSENS easyMAG (bioM{\'e}rieux) and AdV R-gene PCR was performed using the SmartCycler (Cepheid). AdV R-gene results were compared to R-Mix culture (Quidel/Diagnostic Hybrids). For a subset of samples (n= 946) AdV R-gene and R-Mix results were also compared to A549 cell culture. Results: In first intention analysis for NPS the AdV R-gene positive percent agreement (PPA), and negative percent agreement (NPA) were 91.7{\%} and 96.2{\%}, respectively, and for NPW/A were 100{\%} and 94.4{\%}, respectively, compared to R-Mix culture. In second intention analysis, discordant samples only were tested with an AdV real-time PCR assay (Viracor-IBT Labs) and amplicon sequencing. For NPS, the sensitivity, specificity, PPV and NPV for AdV R-gene were 98.9{\%}, 100{\%}, 100{\%}, and 99.9{\%}, respectively and for R-Mix culture were 51.7{\%}, 99.7{\%}, 93.8{\%}, and 96.3{\%}, respectively. For NPW/A, the sensitivity, specificity, PPV and NPV for AdV R-gene were 100{\%}, 99.7{\%}, 97.6{\%}, and 100{\%}, respectively, and for R-Mix culture were 52.5{\%}, 100{\%}, 100{\%}, and 94.9{\%}, respectively. Overall, AdV was detected by AdV R-gene and R-Mix in 7.4{\%} and 4.1{\%} NPS, respectively, and in 10.7{\%} and 5.3{\%} NPW/A, respectively. Children 5. yr and younger had the highest rates of AdV infections. In a subset of specimens (n= 946) the sensitivity of AdV R-gene, R-Mix, and A549 cell culture were 95.0{\%}, 55.4{\%} and 66.3{\%}. Conclusions: AdV R-gene is sensitive and specific for the detection of AdV in NPW/A and NPS samples. AdV R-gene is simple to use and provides a rapid time to results (within 2.5-3 h).",
author = "Ryhana Manji and Xiaotian Zheng and Anami Patel and Malgorzata Kowerska and Margaret Vossinas and Angela Drain and Todd, {Kathleen M.} and Noel Lenny and John Devincenzo and Ginocchio, {Christine C.}",
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TY - JOUR

T1 - Multi-center evaluation of the adenovirus R-gene US assay for the detection of adenovirus in respiratory samples

AU - Manji, Ryhana

AU - Zheng, Xiaotian

AU - Patel, Anami

AU - Kowerska, Malgorzata

AU - Vossinas, Margaret

AU - Drain, Angela

AU - Todd, Kathleen M.

AU - Lenny, Noel

AU - Devincenzo, John

AU - Ginocchio, Christine C.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background: Adenoviruses (AdV) cause a variety of upper and lower respiratory tract infections, with the potential for severe outcomes, especially in persons with immune suppression or other underlying diseases. The ADENOVIRUS US R-gene (AdV R-gene, Argene/bioMérieux) is a FDA cleared real-time PCR assay that utilizes primers and fluorescent probes that target a conserved region of the hexon gene and an internal control DNA. Objectives: This prospective multi-center study evaluated the clinical performance of AdV R-gene for AdV detection in respiratory specimens from symptomatic patients of all ages. Study design: Nucleic acids from nasopharyngeal washes/aspirates (NPW/A; n= 393) and NP flocked swabs (NPS, Copan) (n= 1183) were extracted using NucliSENS easyMAG (bioMérieux) and AdV R-gene PCR was performed using the SmartCycler (Cepheid). AdV R-gene results were compared to R-Mix culture (Quidel/Diagnostic Hybrids). For a subset of samples (n= 946) AdV R-gene and R-Mix results were also compared to A549 cell culture. Results: In first intention analysis for NPS the AdV R-gene positive percent agreement (PPA), and negative percent agreement (NPA) were 91.7% and 96.2%, respectively, and for NPW/A were 100% and 94.4%, respectively, compared to R-Mix culture. In second intention analysis, discordant samples only were tested with an AdV real-time PCR assay (Viracor-IBT Labs) and amplicon sequencing. For NPS, the sensitivity, specificity, PPV and NPV for AdV R-gene were 98.9%, 100%, 100%, and 99.9%, respectively and for R-Mix culture were 51.7%, 99.7%, 93.8%, and 96.3%, respectively. For NPW/A, the sensitivity, specificity, PPV and NPV for AdV R-gene were 100%, 99.7%, 97.6%, and 100%, respectively, and for R-Mix culture were 52.5%, 100%, 100%, and 94.9%, respectively. Overall, AdV was detected by AdV R-gene and R-Mix in 7.4% and 4.1% NPS, respectively, and in 10.7% and 5.3% NPW/A, respectively. Children 5. yr and younger had the highest rates of AdV infections. In a subset of specimens (n= 946) the sensitivity of AdV R-gene, R-Mix, and A549 cell culture were 95.0%, 55.4% and 66.3%. Conclusions: AdV R-gene is sensitive and specific for the detection of AdV in NPW/A and NPS samples. AdV R-gene is simple to use and provides a rapid time to results (within 2.5-3 h).

AB - Background: Adenoviruses (AdV) cause a variety of upper and lower respiratory tract infections, with the potential for severe outcomes, especially in persons with immune suppression or other underlying diseases. The ADENOVIRUS US R-gene (AdV R-gene, Argene/bioMérieux) is a FDA cleared real-time PCR assay that utilizes primers and fluorescent probes that target a conserved region of the hexon gene and an internal control DNA. Objectives: This prospective multi-center study evaluated the clinical performance of AdV R-gene for AdV detection in respiratory specimens from symptomatic patients of all ages. Study design: Nucleic acids from nasopharyngeal washes/aspirates (NPW/A; n= 393) and NP flocked swabs (NPS, Copan) (n= 1183) were extracted using NucliSENS easyMAG (bioMérieux) and AdV R-gene PCR was performed using the SmartCycler (Cepheid). AdV R-gene results were compared to R-Mix culture (Quidel/Diagnostic Hybrids). For a subset of samples (n= 946) AdV R-gene and R-Mix results were also compared to A549 cell culture. Results: In first intention analysis for NPS the AdV R-gene positive percent agreement (PPA), and negative percent agreement (NPA) were 91.7% and 96.2%, respectively, and for NPW/A were 100% and 94.4%, respectively, compared to R-Mix culture. In second intention analysis, discordant samples only were tested with an AdV real-time PCR assay (Viracor-IBT Labs) and amplicon sequencing. For NPS, the sensitivity, specificity, PPV and NPV for AdV R-gene were 98.9%, 100%, 100%, and 99.9%, respectively and for R-Mix culture were 51.7%, 99.7%, 93.8%, and 96.3%, respectively. For NPW/A, the sensitivity, specificity, PPV and NPV for AdV R-gene were 100%, 99.7%, 97.6%, and 100%, respectively, and for R-Mix culture were 52.5%, 100%, 100%, and 94.9%, respectively. Overall, AdV was detected by AdV R-gene and R-Mix in 7.4% and 4.1% NPS, respectively, and in 10.7% and 5.3% NPW/A, respectively. Children 5. yr and younger had the highest rates of AdV infections. In a subset of specimens (n= 946) the sensitivity of AdV R-gene, R-Mix, and A549 cell culture were 95.0%, 55.4% and 66.3%. Conclusions: AdV R-gene is sensitive and specific for the detection of AdV in NPW/A and NPS samples. AdV R-gene is simple to use and provides a rapid time to results (within 2.5-3 h).

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