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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/22731

Title: Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests)
Authors: Cuschieri, Kate
Geraets, Daan
Cuzick, Jack
Cadman, Louise
Moore, Catherine
Vanden Broeck, Davy
Padalko, Elizaveta
Quint, Wim
Arbyn, Marc
Issue Date: 2016
Citation: 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.
Notes: [Cuschieri, Kate; Moore, Catherine] Royal Infirm Edinburgh NHS Trust, Scottish HPV Reference Lab, Edinburgh, Midlothian, Scotland. [Geraets, Daan; Quint, Wim] DDL Diagnost Lab, Rijswijk, Netherlands. [Cuzick, Jack; Cadman, Louise] Wolfson Inst Prevent Med, Ctr Canc Prevent, Charterhouse Sq, London, England. [Vanden Broeck, Davy; Padalko, Elisaveta] Natl Reference Ctr HPV, Brussels, Belgium. [Vanden Broeck, Davy] Univ Ghent, Int Ctr Reprod Hlth, Ghent, Belgium. [Vanden Broeck, Davy] AML, Lab Mol Pathol, Antwerp, Belgium. [Padalko, Elisaveta] Ghent Univ Hosp, Dept Lab Med, Ghent, Belgium. [Padalko, Elisaveta] Hasselt Univ, Sch Life Sci, Diepenbeek, Belgium. [Arbyn, Marc] Sci Inst Publ Hlth, Canc Epidemiol Unit, Brussels, Belgium. [Arbyn, Marc] Sci Inst Publ Hlth, Belgian Canc Ctr, Brussels, Belgium.
URI: http://hdl.handle.net/1942/22731
DOI: 10.1128/JCM.00897-16
ISI #: 000384251300022
ISSN: 0095-1137
Category: A1
Type: Journal Contribution
Validation: ecoom, 2017
Appears in Collections: Research publications

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