Study comparing human papillomavirus (HPV) real-time multiplex PCR and Hybrid Capture II INNO-LiPA v2 HPV genotyping PCR assays

Thomas Iftner; Liesje Germ; Ryan Swoyer; Susanne Kruger Kjaer; J Gabrielle Breugelmans; Christian Munk; Frank Stubenrauch; Joseph Antonello; Janine T Bryan; Frank J Taddeo

doi:10.1128/JCM.01907-08

Study comparing human papillomavirus (HPV) real-time multiplex PCR and Hybrid Capture II INNO-LiPA v2 HPV genotyping PCR assays

Thomas Iftner, Liesje Germ, Ryan Swoyer, Susanne Kruger Kjaer, J Gabrielle Breugelmans, Christian Munk, Frank Stubenrauch, Joseph Antonello, Janine T Bryan, Frank J Taddeo

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

25 Citationer (Scopus)

Abstract

Udgivelsesdato: 2009-Jul

Originalsprog	Engelsk
Tidsskrift	Journal of Clinical Microbiology
Vol/bind	47
Udgave nummer	7
Sider (fra-til)	2106-13
Antal sider	7
ISSN	0095-1137
DOI	https://doi.org/10.1128/JCM.01907-08
Status	Udgivet - 2009

Bibliografisk note

Keywords: Adolescent; Adult; Female; Genotype; Humans; Middle Aged; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; Papillomaviridae; Polymerase Chain Reaction; Sensitivity and Specificity; Young Adult

Adgang til dokumentet

10.1128/JCM.01907-08

Citationsformater

@article{39078e6067f111df928f000ea68e967b,

title = "Study comparing human papillomavirus (HPV) real-time multiplex PCR and Hybrid Capture II INNO-LiPA v2 HPV genotyping PCR assays",

abstract = "Human papillomavirus (HPV) DNA genotyping is an essential test to establish efficacy in HPV vaccine clinical trials and HPV prevalence in natural history studies. A number of HPV DNA genotyping methods have been cited in the literature, but the comparability of the outcomes from the different methods has not been well characterized. Clinically, cytology is used to establish possible HPV infection. We evaluated the sensitivity and specificity of HPV multiplex PCR assays compared to those of the testing scheme of the Hybrid Capture II (HCII) assay followed by an HPV PCR/line hybridization assay (HCII-LiPA v2). SurePath residual samples were split into two aliquots. One aliquot was subjected to HCII testing followed by DNA extraction and LiPA v2 genotyping. The second aliquot was shipped to a second laboratory, where DNA was extracted and HPV multiplex PCR testing was performed. Comparisons were evaluated for 15 HPV types common in both assays. A slightly higher proportion of samples tested positive by the HPV multiplex PCR than by the HCII-LiPA v2 assay. The sensitivities of the multiplex PCR assay relative to those of the HCII-LiPA v2 assay for HPV types 6, 11, 16, and 18, for example, were 0.806, 0.646, 0.920, and 0.860, respectively; the specificities were 0.986, 0.998, 0.960, and 0.986, respectively. The overall comparability of detection of the 15 HPV types was quite high. Analyses of DNA genotype testing compared to cytology results demonstrated a significant discordance between cytology-negative (normal) and HPV DNA-positive results. This demonstrates the challenges of cytological diagnosis and the possibility that a significant number of HPV-infected cells may appear cytologically normal.",

author = "Thomas Iftner and Liesje Germ and Ryan Swoyer and Kjaer, {Susanne Kruger} and Breugelmans, {J Gabrielle} and Christian Munk and Frank Stubenrauch and Joseph Antonello and Bryan, {Janine T} and Taddeo, {Frank J}",

note = "Keywords: Adolescent; Adult; Female; Genotype; Humans; Middle Aged; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; Papillomaviridae; Polymerase Chain Reaction; Sensitivity and Specificity; Young Adult",

year = "2009",

doi = "10.1128/JCM.01907-08",

language = "English",

volume = "47",

pages = "2106--13",

journal = "Journal of Clinical Microbiology",

issn = "0095-1137",

publisher = "American Society for Microbiology",

number = "7",

}

TY - JOUR

T1 - Study comparing human papillomavirus (HPV) real-time multiplex PCR and Hybrid Capture II INNO-LiPA v2 HPV genotyping PCR assays

AU - Iftner, Thomas

AU - Germ, Liesje

AU - Swoyer, Ryan

AU - Kjaer, Susanne Kruger

AU - Breugelmans, J Gabrielle

AU - Munk, Christian

AU - Stubenrauch, Frank

AU - Antonello, Joseph

AU - Bryan, Janine T

AU - Taddeo, Frank J

N1 - Keywords: Adolescent; Adult; Female; Genotype; Humans; Middle Aged; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; Papillomaviridae; Polymerase Chain Reaction; Sensitivity and Specificity; Young Adult

PY - 2009

Y1 - 2009

N2 - Human papillomavirus (HPV) DNA genotyping is an essential test to establish efficacy in HPV vaccine clinical trials and HPV prevalence in natural history studies. A number of HPV DNA genotyping methods have been cited in the literature, but the comparability of the outcomes from the different methods has not been well characterized. Clinically, cytology is used to establish possible HPV infection. We evaluated the sensitivity and specificity of HPV multiplex PCR assays compared to those of the testing scheme of the Hybrid Capture II (HCII) assay followed by an HPV PCR/line hybridization assay (HCII-LiPA v2). SurePath residual samples were split into two aliquots. One aliquot was subjected to HCII testing followed by DNA extraction and LiPA v2 genotyping. The second aliquot was shipped to a second laboratory, where DNA was extracted and HPV multiplex PCR testing was performed. Comparisons were evaluated for 15 HPV types common in both assays. A slightly higher proportion of samples tested positive by the HPV multiplex PCR than by the HCII-LiPA v2 assay. The sensitivities of the multiplex PCR assay relative to those of the HCII-LiPA v2 assay for HPV types 6, 11, 16, and 18, for example, were 0.806, 0.646, 0.920, and 0.860, respectively; the specificities were 0.986, 0.998, 0.960, and 0.986, respectively. The overall comparability of detection of the 15 HPV types was quite high. Analyses of DNA genotype testing compared to cytology results demonstrated a significant discordance between cytology-negative (normal) and HPV DNA-positive results. This demonstrates the challenges of cytological diagnosis and the possibility that a significant number of HPV-infected cells may appear cytologically normal.

AB - Human papillomavirus (HPV) DNA genotyping is an essential test to establish efficacy in HPV vaccine clinical trials and HPV prevalence in natural history studies. A number of HPV DNA genotyping methods have been cited in the literature, but the comparability of the outcomes from the different methods has not been well characterized. Clinically, cytology is used to establish possible HPV infection. We evaluated the sensitivity and specificity of HPV multiplex PCR assays compared to those of the testing scheme of the Hybrid Capture II (HCII) assay followed by an HPV PCR/line hybridization assay (HCII-LiPA v2). SurePath residual samples were split into two aliquots. One aliquot was subjected to HCII testing followed by DNA extraction and LiPA v2 genotyping. The second aliquot was shipped to a second laboratory, where DNA was extracted and HPV multiplex PCR testing was performed. Comparisons were evaluated for 15 HPV types common in both assays. A slightly higher proportion of samples tested positive by the HPV multiplex PCR than by the HCII-LiPA v2 assay. The sensitivities of the multiplex PCR assay relative to those of the HCII-LiPA v2 assay for HPV types 6, 11, 16, and 18, for example, were 0.806, 0.646, 0.920, and 0.860, respectively; the specificities were 0.986, 0.998, 0.960, and 0.986, respectively. The overall comparability of detection of the 15 HPV types was quite high. Analyses of DNA genotype testing compared to cytology results demonstrated a significant discordance between cytology-negative (normal) and HPV DNA-positive results. This demonstrates the challenges of cytological diagnosis and the possibility that a significant number of HPV-infected cells may appear cytologically normal.

U2 - 10.1128/JCM.01907-08

DO - 10.1128/JCM.01907-08

M3 - Journal article

C2 - 19420164

SN - 0095-1137

VL - 47

SP - 2106

EP - 2113

JO - Journal of Clinical Microbiology

JF - Journal of Clinical Microbiology

IS - 7

ER -