Comparison of the anyplex II HPV28 assay with the hybrid capture 2 assay for the detection of HPV infection
Abstract
Background Human papillomavirus (HPV) testing is an important part of cervical cancer screening and management of women with abnormal cytology results. The Hybrid Capture 2 (HC2) has been recommended for use as a reference test. Objective To evaluate a new real-time PCR assay (Anyplex II HPV28) for detecting high risk (HR) HPV and to compare it to the HC2. In addition, we compared the genotyping results of the Anyplex II HPV28 to those of sequencing analysis. Study design A total of 1114 cervical swab specimens were consecutively obtained from a single healthcare center. We submitted all specimens for HPV detection with Anyplex II HPV28 and HC2, then analyzed the discordant results using multiplex PCR followed by direct sequencing. Results HC2 detected 72 (6.5%) cases with HR HPV, while Anyplex II HPV28 identified 138 (12.4%) cases. The overall agreement rate was 91.4% (1018/1114) of cases. Discordant results between these two assays were observed in 96 cases; 15 were positive only by HC2, and 81 were positive only by Anyplex II HPV28. Sequencing analyses performed in 80 cases of discordant results revealed 11 false-positive, and 67 false-negative results using HC2 tests and two false-positive results using Anyplex II HPV28. Conclusions The Anyplex II HPV28 assay is analytically more sensitive in the detection of the 13 HR types represented by the HC2 assay and exhibited a higher concordance with comprehensive genotyping based on the sequencing analysis, and it could be used…
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Anyplex II HPV HR Detection is a multiplex real-time PCR using tagging oligonucleotide cleavage and extension (TOCE) technology for simultaneous detection and genotyping of 14 high-risk HPV types, including HPV16 and HPV18.
“Anyplex TM II HPV HR Detection (Seegene, Seoul, Korea) is a multiplex real-time PCR using tagging oligonucleotide cleavage and extension (TOCE) technology for simultaneous detection and genotyping of 14 high-risk (HR) HPV types, including HPV16 and HPV18.”
From Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening (2016) · cites this paper as [4]
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].”
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References 27 · Cited by 55
- Authors
- Kwon, M.-J., Roh, K. H., Park, H., & Woo, H.-Y.
- Affiliations
- Kangbuk Samsung Hospital (KR)
- Corresponding author
- Woo, Hee-Yeon
- Venue
- Journal of Clinical Virology
- Publisher
- Elsevier BV
- Published
- 2014-04
- Volume
- 59
- Issue
- 4
- Pages
- 246-249
- ISSN
- 1386-6532 (ISSN-L)
- OpenAlex
- W1983858378
- Cited by
- 55
- References
- 27
- Citations by year
- 2024: 6 · 2023: 4 · 2022: 2 · 2021: 6 · 2020: 2 · 2019: 4 · 2018: 6 · 2017: 5 · 2016: 14 · 2015: 6
- FWCI
- 6.30
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Virology (publishedVersion)
- PubMed (publishedVersion)
- 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
- Hybrid Capture 2, HPV testing, high-risk HPV, HPV genotyping, cervical cancer screening, assay comparison, assay sensitivity, false positives and false negatives
- MeSH terms
- Adult, Aged, Female, Humans, Middle Aged, Sensitivity and Specificity, Virology, Molecular Diagnostic Techniques, Papillomaviridae, Papillomavirus Infections, Early Detection of Cancer, Young Adult, Genotyping Techniques, Real-Time Polymerase Chain Reaction
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