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Performance of a cartridge-based assay for detection of clinically significant human papillomavirus (HPV) infection : lessons from VALGENT (Validation of HPV Genotyping Tests)

Kate Cuschieri, Daan Geraets, Jack Cuzick, Louise Cadman, Catherine Moore, Davy Vanden Broeck UGent, Elizaveta Padalko UGent, Wim Quint and Marc Arbyn UGent (2016) JOURNAL OF CLINICAL MICROBIOLOGY. 54(9). p.2337-2342
abstract
The Validation of Human Papillomavirus (HPV) Genotyping Tests (VALGENT) studies offer an opportunity to clinically validate HPV assays for use in primary screening for cervical cancer and also provide a framework for the comparison of analytical and type-specific performance. Through VALGENT, we assessed the performance of the cartridge-based Xpert HPV assay (Xpert HPV), which detects 14 high-risk (HR) types and resolves HPV16 and HPV 18/45. Samples from women attending the United Kingdom cervical screening program enriched with cytologically abnormal samples were collated. All had been previously tested by a clinically validated standard comparator test (SCT), the GP5+/6+ enzyme immunoassay (EIA). The clinical sensitivity and specificity of the Xpert HPV for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and CIN3+ relative to those of the SCT were assessed as were the inter-and intralaboratory reproducibilities according to international criteria for test validation. Type concordance for HPV16 and HPV 18/45 between the Xpert HPV and the SCT was also analyzed. The Xpert HPV detected 94% of CIN2+ and 98% of CIN3+ lesions among all screened women and 90% of CIN2+ and 96% of CIN3+ lesions in women 30 years and older. The specificity for CIN1 or less (<= CIN1) was 83% (95% confidence interval [CI], 80 to 85%) in all women and 88% (95% CI, 86 to 91%) in women 30 years and older. Inter-and intralaboratory agreements for the Xpert HPV were 98% and 97%, respectively. The kappa agreements for HPV16 and HPV18/45 between the clinically validated reference test (GP5+/6+ LMNX) and the Xpert HPV were 0.92 and 0.91, respectively. The clinical performance and reproducibility of the Xpert HPV are comparable to those of well-established HPV assays and fulfill the criteria for use in primary cervical cancer screening.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
CERVICAL-CANCER, RISK, WOMEN, COLPOSCOPY, DNA, PCR
journal title
JOURNAL OF CLINICAL MICROBIOLOGY
J. Clin. Microbiol.
volume
54
issue
9
pages
2337 - 2342
Web of Science type
Article
Web of Science id
000384251300022
JCR category
MICROBIOLOGY
JCR impact factor
3.712 (2016)
JCR rank
33/124 (2016)
JCR quartile
2 (2016)
ISSN
0095-1137
1098-660X
DOI
10.1128/JCM.00897-16
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
8500602
handle
http://hdl.handle.net/1854/LU-8500602
date created
2017-01-06 10:15:39
date last changed
2017-01-16 10:38:53
@article{8500602,
  abstract     = {The Validation of Human Papillomavirus (HPV) Genotyping Tests (VALGENT) studies offer an opportunity to clinically validate HPV assays for use in primary screening for cervical cancer and also provide a framework for the comparison of analytical and type-specific performance. Through VALGENT, we assessed the performance of the cartridge-based Xpert HPV assay (Xpert HPV), which detects 14 high-risk (HR) types and resolves HPV16 and HPV 18/45. Samples from women attending the United Kingdom cervical screening program enriched with cytologically abnormal samples were collated. All had been previously tested by a clinically validated standard comparator test (SCT), the GP5+/6+ enzyme immunoassay (EIA). The clinical sensitivity and specificity of the Xpert HPV for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and CIN3+ relative to those of the SCT were assessed as were the inter-and intralaboratory reproducibilities according to international criteria for test validation. Type concordance for HPV16 and HPV 18/45 between the Xpert HPV and the SCT was also analyzed. The Xpert HPV detected 94\% of CIN2+ and 98\% of CIN3+ lesions among all screened women and 90\% of CIN2+ and 96\% of CIN3+ lesions in women 30 years and older. The specificity for CIN1 or less ({\textlangle}= CIN1) was 83\% (95\% confidence interval [CI], 80 to 85\%) in all women and 88\% (95\% CI, 86 to 91\%) in women 30 years and older. Inter-and intralaboratory agreements for the Xpert HPV were 98\% and 97\%, respectively. The kappa agreements for HPV16 and HPV18/45 between the clinically validated reference test (GP5+/6+ LMNX) and the Xpert HPV were 0.92 and 0.91, respectively. The clinical performance and reproducibility of the Xpert HPV are comparable to those of well-established HPV assays and fulfill the criteria for use in primary cervical cancer screening.},
  author       = {Cuschieri, Kate and Geraets, Daan and Cuzick, Jack and Cadman, Louise and Moore, Catherine and Vanden Broeck, Davy and Padalko, Elizaveta and Quint, Wim and Arbyn, Marc},
  issn         = {0095-1137},
  journal      = {JOURNAL OF CLINICAL MICROBIOLOGY},
  keyword      = {CERVICAL-CANCER,RISK,WOMEN,COLPOSCOPY,DNA,PCR},
  language     = {eng},
  number       = {9},
  pages        = {2337--2342},
  title        = {Performance of a cartridge-based assay for detection of clinically significant human papillomavirus (HPV) infection : lessons from VALGENT (Validation of HPV Genotyping Tests)},
  url          = {http://dx.doi.org/10.1128/JCM.00897-16},
  volume       = {54},
  year         = {2016},
}

Chicago
Cuschieri, Kate, Daan Geraets, Jack Cuzick, Louise Cadman, Catherine Moore, Davy Vanden Broeck, Elizaveta Padalko, Wim Quint, and Marc Arbyn. 2016. “Performance of a Cartridge-based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection : Lessons from VALGENT (Validation of HPV Genotyping Tests).” Journal of Clinical Microbiology 54 (9): 2337–2342.
APA
Cuschieri, K., Geraets, D., Cuzick, J., Cadman, L., Moore, C., Vanden Broeck, D., Padalko, E., et al. (2016). Performance of a cartridge-based assay for detection of clinically significant human papillomavirus (HPV) infection : lessons from VALGENT (Validation of HPV Genotyping Tests). JOURNAL OF CLINICAL MICROBIOLOGY, 54(9), 2337–2342.
Vancouver
1.
Cuschieri K, Geraets D, Cuzick J, Cadman L, Moore C, Vanden Broeck D, et al. Performance of a cartridge-based assay for detection of clinically significant human papillomavirus (HPV) infection : lessons from VALGENT (Validation of HPV Genotyping Tests). JOURNAL OF CLINICAL MICROBIOLOGY. 2016;54(9):2337–42.
MLA
Cuschieri, Kate, Daan Geraets, Jack Cuzick, et al. “Performance of a Cartridge-based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection : Lessons from VALGENT (Validation of HPV Genotyping Tests).” JOURNAL OF CLINICAL MICROBIOLOGY 54.9 (2016): 2337–2342. Print.