Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests)
Open accessAbstract
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 HPV18/45. 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 HPV18/45 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.
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When Anyplex28 and Xpert HPV were evaluated against the GP5+/6+ EIA comparator HPV assay, sensitivity and specificity were 98.3% and 93.6% for Anyplex28, and 94.1% and 90.3% for Xpert HPV, respectively.
“When Anyplex28 and Xpert HPV were evaluated against the GP5+/6 + EIA comparator HPV assay, sensitivity and specificity were 98.3% and 93.6% for Anyplex28, and 94.1%, and 90.3% for Xpert HPV, respectively [14, 15].”
From Comparative analysis of SD biosensor standard™ M10 HPV and seegene anyplex™ II HPV HR for detecting high-risk human papillomavirus: a concordance study (2025) · cites this paper as [14]
Table 2 (Discussion; page not provided) reports 94.1% sensitivity for Xpert HPV in detecting CIN2+ in the VALGENT-2 all-ages group, using GP5+/6+ EIA as the comparator. It reports 82.7% specificity for women with ≤CIN1, not 90.3%. This paper evaluates Xpert HPV; the Anyplex28 figures are not established by this source. (LLM, conf=0.92)
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- Authors
- Cuschieri, K., Geraets, D., Cuzick, J., Cadman, L., Moore, C., Vanden Broeck, D., Padalko, E., Quint, W., & Arbyn, M.
- Affiliations
- Edinburgh Royal Infirmary (GB)
- DDL Diagnostic Laboratory (NL)
- Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, London, United Kingdom
- National Reference Centre for HPV, Brussels, Belgium
- Institut Scientifique de Santé Publique (BE)
- Venue
- Journal of Clinical Microbiology
- Publisher
- American Society for Microbiology
- Published
- 2016-09
- Volume
- 54
- Issue
- 9
- Pages
- 2337-2342
- ISSN
- 0095-1137 (ISSN-L)
- 1098-660X
- PMC
- PMC5005513
- OpenAlex
- W2510482247
- Cited by
- 55
- References
- 16
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 2 · 2023: 3 · 2022: 3 · 2021: 6 · 2020: 5 · 2019: 6 · 2018: 12 · 2017: 12
- FWCI
- 9.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Microbiology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Document Server@UHasselt (UHasselt) (submittedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion)
- Funders
- Scottish Government
- Cancer Research UK (16891)
- European Commission (603019)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Keywords
- human papillomavirus, HPV genotyping, cervical cancer screening, cervical intraepithelial neoplasia, CIN2+ detection, assay validation, HPV16, high-risk HPV, sensitivity and specificity
- MeSH terms
- Adolescent, Adult, Aged, Uterine Cervical Neoplasms, Female, United Kingdom, Humans, Middle Aged, Sensitivity and Specificity, Reproducibility of Results, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer, Young Adult, Genotyping Techniques
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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