Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer

Results from the CLEAR HPV study

Philip E. Castle, Jack Cuzick, Mark H. Stoler, Thomas C. Wright, Jennifer L. Reid, Janel Dockter, Cristina Giachetti, Damon Getman

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Objectives: The Aptima human papillomavirus (HPV) 16 18/45 Genotype (GT) assay (AHPV-GT) is a qualitative E6/E7 oncogene messenger RNA test that detects HPV 16 and a pool of HPV 18 and 45. The CLEAR (Clinical Evaluation of APTIMA mRNA) study was the pivotal, prospective, multicenter US clinical study to validate the Aptima HPV (AHPV) assays. Methods: In this analysis, we evaluated the clinical performance of AHPV and AHPV-GT assays for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) and grade 3 (CIN3) or adenocarcinoma in situ in 912 women with atypical squamous cells of undetermined significance (ASC-US) Papanicolaou result. The AHPV-GT assay was performed on high-risk HPV (hrHPV) positives as determined by the AHPV assay. Results: Overall, the percent positive for hrHPV was 38.8% (354/912), of which 34.2% (121/354) were GT positive. Among hrHPV-positive women, the risks of CIN2+ were 37.0% for HPV 16 positives, 15.9% for HPV 18/45 positives, 14.3% for other hrHPV positives, and 2.2% for AHPV negatives. The risks of CIN3+ were 20.5% for HPV 16 positives, 9.1% for HPV 18/45 positives, 4.3% for other hrHPV positives, and 0.7% for HPV negatives. Conclusions: We demonstrated that AHPV-GT is a reliable and effective test for cervical cancer risk stratification in women with an ASC-US cytology diagnosis.

Original languageEnglish (US)
Pages (from-to)160-167
Number of pages8
JournalAmerican Journal of Clinical Pathology
Volume143
Issue number2
DOIs
StatePublished - Feb 1 2015

Fingerprint

Human papillomavirus 18
Human papillomavirus 16
Cell Biology
Messenger RNA
Genotype
Atypical Squamous Cells of the Cervix
Cervical Intraepithelial Neoplasia
Oncogenes
Uterine Cervical Neoplasms

Keywords

  • Aptima
  • ASC-US
  • Cervical cancer
  • Cervical intraepithelial neoplasia
  • E6/E7 mRNA
  • Genotyping
  • HPV

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer : Results from the CLEAR HPV study. / Castle, Philip E.; Cuzick, Jack; Stoler, Mark H.; Wright, Thomas C.; Reid, Jennifer L.; Dockter, Janel; Giachetti, Cristina; Getman, Damon.

In: American Journal of Clinical Pathology, Vol. 143, No. 2, 01.02.2015, p. 160-167.

Research output: Contribution to journalArticle

Castle, Philip E. ; Cuzick, Jack ; Stoler, Mark H. ; Wright, Thomas C. ; Reid, Jennifer L. ; Dockter, Janel ; Giachetti, Cristina ; Getman, Damon. / Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer : Results from the CLEAR HPV study. In: American Journal of Clinical Pathology. 2015 ; Vol. 143, No. 2. pp. 160-167.
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abstract = "Objectives: The Aptima human papillomavirus (HPV) 16 18/45 Genotype (GT) assay (AHPV-GT) is a qualitative E6/E7 oncogene messenger RNA test that detects HPV 16 and a pool of HPV 18 and 45. The CLEAR (Clinical Evaluation of APTIMA mRNA) study was the pivotal, prospective, multicenter US clinical study to validate the Aptima HPV (AHPV) assays. Methods: In this analysis, we evaluated the clinical performance of AHPV and AHPV-GT assays for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) and grade 3 (CIN3) or adenocarcinoma in situ in 912 women with atypical squamous cells of undetermined significance (ASC-US) Papanicolaou result. The AHPV-GT assay was performed on high-risk HPV (hrHPV) positives as determined by the AHPV assay. Results: Overall, the percent positive for hrHPV was 38.8{\%} (354/912), of which 34.2{\%} (121/354) were GT positive. Among hrHPV-positive women, the risks of CIN2+ were 37.0{\%} for HPV 16 positives, 15.9{\%} for HPV 18/45 positives, 14.3{\%} for other hrHPV positives, and 2.2{\%} for AHPV negatives. The risks of CIN3+ were 20.5{\%} for HPV 16 positives, 9.1{\%} for HPV 18/45 positives, 4.3{\%} for other hrHPV positives, and 0.7{\%} for HPV negatives. Conclusions: We demonstrated that AHPV-GT is a reliable and effective test for cervical cancer risk stratification in women with an ASC-US cytology diagnosis.",
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T1 - Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer

T2 - Results from the CLEAR HPV study

AU - Castle, Philip E.

AU - Cuzick, Jack

AU - Stoler, Mark H.

AU - Wright, Thomas C.

AU - Reid, Jennifer L.

AU - Dockter, Janel

AU - Giachetti, Cristina

AU - Getman, Damon

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KW - Genotyping

KW - HPV

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