Performance evaluation of Anyplex™II HPV28 detection kit in a routine diagnostic setting: Comparison with the HPV Sign® Genotyping Test
Abstract
Anyplex™II HPV28 is a new PCR assay designed for HPV genotyping. It can detect 28 HPV types including 19 high-risk and 9 low-risk types. This study evaluated the performance of Anyplex™II HPV28 on 123 fresh cervical samples screened in parallel with HPV Sign® Genotyping Test. Of the 123 samples screened, 93 were positive, 15 negative, and 15 discordant. The total number of HPV positive samples combined was 108: 38 single infections and 70 multiple infections. The agreement between the two tests was 87.8%, κ=0.592. Genotype specific agreement was strong for HPV 16 (k=0.761), HPV 18 (k=0.674), and HPV 35 (k=0.796). Sensitivity and specificity of Anyplex™II HPV28 assay using HPV Sign® Genotyping Test as reference was 84.8% and 94%; conversely, sensitivity and specificity of HPV Sign® Genotyping Test was 29% and 99.5%. Anyplex™II HPV28 assay is a sensitive and specific assay suitable for HPV genotyping but requires clinical validation.
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In several studies that compared HPV genotyping methodologies, AnyplexTM II HPV28 demonstrated good agreement with other HPV assays, including LA.
“In several studies that compared HPV genotyping methodologies, Anyplex™ II HPV28 demonstrated good agreement with other HPV assays, including LA.”
AnyplexTM II HPV28's good agreement with other HPV assays is likely due to its highly sensitive multiplexed detection approach.
“This is likely due to its highly sensitive multiplexed detection approach [8, 28–30].”
Cites
Ronco, G., Dillner, J., Elfström, K. M., Tunesi, S., Snijders, P. J. F., Arbyn, M., Kitchener, H., Segnan, N., Gilham, C., Giorgi-Rossi, P., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62218-7 · Cited by 1,810 · see citing works
Comparison of Seegene Anyplex II HPV28 with the PGMY-CHUV Assay for Human Papillomavirus Genotyping
Estrade, C., & Sahli, R. (2014) · Journal of Clinical Microbiology · doi:10.1128/jcm.02749-13 · Cited by 57 · see citing works
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Bandeira, I. C., Comerlato, J., Bessel, M., Fernandes, B. V., Mota, G., Villa, L. L., de Souza, F. M. A., Pereira, G. F. M., & Wendland, E. M. (2024) · PLOS ONE · doi:10.1371/journal.pone.0305122 · Cited by 3 · see citing works
“HPV genotype testing represents an important tool for studying the carcinogenic potential of HPV types and is used widely to screen for and follow-up persistent infections that could lead to cervical cancer [7, 8].”
BackgroundMethod
- Authors
- Marcuccilli, F., Farchi, F., Mirandola, W., Ciccozzi, M., Paba, P., Bonanno, E., Perno, C. F., & Ciotti, M.
- Affiliations
- Policlinico Tor Vergata (IT)
- Istituto Superiore di Sanità (IT)
- University of Rome Tor Vergata (IT)
- Corresponding author
- Ciotti, Marco
- Venue
- Journal of Virological Methods
- Publisher
- Elsevier BV
- Published
- 2015-06
- Volume
- 217
- Pages
- 8-13
- ISSN
- 0166-0934 (ISSN-L)
- OpenAlex
- W1971829382
- Cited by
- 15
- References
- 2
- Citations by year
- 2025: 1 · 2024: 2 · 2022: 1 · 2021: 2 · 2020: 1 · 2019: 3 · 2018: 2 · 2016: 3
- FWCI
- 1.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Virological Methods (publishedVersion)
- PubMed (publishedVersion)
- Cineca Institutional Research Information System (Tor Vergata University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
- Keywords
- HPV genotyping, human papillomavirus, cervical samples, assay evaluation, test agreement, HPV16, HPV 18, HPV35, high-risk HPV, multiple HPV infection, sensitivity and specificity
- MeSH terms
- Cervix Uteri, Female, Humans, Sensitivity and Specificity, Papillomaviridae, Papillomavirus Infections, Genotyping Techniques
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