Onclarity Human Papillomavirus Extended Genotyping in the Management of Cervical Intraepithelial Neoplasia 2+ Lesions

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Abstract

Objective Many methods are available today for human papillomavirus (HPV) testing; they differ for technology, targets, and information on the genotypes detected. In this study, we evaluated the performance of the Onclarity HPV assay in detection and follow-up of cervical preneoplastic lesions. Materials and Methods One hundred sixty-seven women referred to the European Institute of Oncology, Milan, for treatment of cervical lesions were enrolled. We investigated the utility of Onclarity extended genotyping HPV test in the management of cervical intraepithelial neoplasia (CIN) 2+ preneoplastic lesion. Results At baseline, the concordance was 92% (150/163) between Onclarity and Hybrid Capture 2 (HC2) and 93% (142/152) between Onclarity and linear array, respectively. At follow-up, the concordance between Onclarity and HC2 was 80%. Seven women relapsed: 6 had persistence of the same genotypes and 1 patient tested negative not only with Onclarity but also with HC2 for the presence of a low-risk genotype in the sample. Conclusions This study showed that the evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline.

Original languageEnglish
Pages (from-to)39-42
Number of pages4
JournalJournal of Lower Genital Tract Disease
Volume23
Issue number1
DOIs
Publication statusPublished - Jan 1 2019

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Cervical Intraepithelial Neoplasia
Genotype
Technology
Recurrence

Keywords

  • cervical intraepithelial neoplasia
  • follow-up
  • HPV
  • real-time polymerase chain reaction genotyping

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

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title = "Onclarity Human Papillomavirus Extended Genotyping in the Management of Cervical Intraepithelial Neoplasia 2+ Lesions",
abstract = "Objective Many methods are available today for human papillomavirus (HPV) testing; they differ for technology, targets, and information on the genotypes detected. In this study, we evaluated the performance of the Onclarity HPV assay in detection and follow-up of cervical preneoplastic lesions. Materials and Methods One hundred sixty-seven women referred to the European Institute of Oncology, Milan, for treatment of cervical lesions were enrolled. We investigated the utility of Onclarity extended genotyping HPV test in the management of cervical intraepithelial neoplasia (CIN) 2+ preneoplastic lesion. Results At baseline, the concordance was 92{\%} (150/163) between Onclarity and Hybrid Capture 2 (HC2) and 93{\%} (142/152) between Onclarity and linear array, respectively. At follow-up, the concordance between Onclarity and HC2 was 80{\%}. Seven women relapsed: 6 had persistence of the same genotypes and 1 patient tested negative not only with Onclarity but also with HC2 for the presence of a low-risk genotype in the sample. Conclusions This study showed that the evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline.",
keywords = "cervical intraepithelial neoplasia, follow-up, HPV, real-time polymerase chain reaction genotyping",
author = "Fabio Bottari and Iacobone, {Anna Daniela} and Sara Boveri and Preti, {Eleonora Petra} and Dorella Franchi and Luciano Mariani and Mario Preti and Fabio Landoni and Rita Passerini and Sandri, {Maria Teresa}",
year = "2019",
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doi = "10.1097/LGT.0000000000000441",
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T1 - Onclarity Human Papillomavirus Extended Genotyping in the Management of Cervical Intraepithelial Neoplasia 2+ Lesions

AU - Bottari, Fabio

AU - Iacobone, Anna Daniela

AU - Boveri, Sara

AU - Preti, Eleonora Petra

AU - Franchi, Dorella

AU - Mariani, Luciano

AU - Preti, Mario

AU - Landoni, Fabio

AU - Passerini, Rita

AU - Sandri, Maria Teresa

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objective Many methods are available today for human papillomavirus (HPV) testing; they differ for technology, targets, and information on the genotypes detected. In this study, we evaluated the performance of the Onclarity HPV assay in detection and follow-up of cervical preneoplastic lesions. Materials and Methods One hundred sixty-seven women referred to the European Institute of Oncology, Milan, for treatment of cervical lesions were enrolled. We investigated the utility of Onclarity extended genotyping HPV test in the management of cervical intraepithelial neoplasia (CIN) 2+ preneoplastic lesion. Results At baseline, the concordance was 92% (150/163) between Onclarity and Hybrid Capture 2 (HC2) and 93% (142/152) between Onclarity and linear array, respectively. At follow-up, the concordance between Onclarity and HC2 was 80%. Seven women relapsed: 6 had persistence of the same genotypes and 1 patient tested negative not only with Onclarity but also with HC2 for the presence of a low-risk genotype in the sample. Conclusions This study showed that the evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline.

AB - Objective Many methods are available today for human papillomavirus (HPV) testing; they differ for technology, targets, and information on the genotypes detected. In this study, we evaluated the performance of the Onclarity HPV assay in detection and follow-up of cervical preneoplastic lesions. Materials and Methods One hundred sixty-seven women referred to the European Institute of Oncology, Milan, for treatment of cervical lesions were enrolled. We investigated the utility of Onclarity extended genotyping HPV test in the management of cervical intraepithelial neoplasia (CIN) 2+ preneoplastic lesion. Results At baseline, the concordance was 92% (150/163) between Onclarity and Hybrid Capture 2 (HC2) and 93% (142/152) between Onclarity and linear array, respectively. At follow-up, the concordance between Onclarity and HC2 was 80%. Seven women relapsed: 6 had persistence of the same genotypes and 1 patient tested negative not only with Onclarity but also with HC2 for the presence of a low-risk genotype in the sample. Conclusions This study showed that the evaluation of the HPV genotype persistence may represent a valid option to monitor patients treated for CIN 2+ lesions, because relapses were detected only in patients with persistence of the same genotype detected at baseline.

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KW - follow-up

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KW - real-time polymerase chain reaction genotyping

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