Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany

Thomas Iftner, Sven Becker, Klaus-Joachim Neis, Alejandra Castanon, Angelika Iftner, Barbara Holz, Annette Staebler, Melanie Henes, Katharina Rall, Juliane Haedicke, Claus Hann von Weyhern, Andreas Clad, Sara Brucker, Peter Sasieni

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Abstract

Testing for E6/E7 mRNA in cells infected with high-risk (HR) human papillomavirus (HPV) might improve the specificity of HPV testing for the identification of cervical precancerous lesions. Here we compared the RNA-based Aptima HPV (AHPV) assay (Hologic) and the DNA-based Hybrid Capture 2 (HC2) HPV test (Qiagen) to liquid-based cytology (LBC) for women undergoing routine cervical screening. A total of 10,040 women, 30 to 60 years of age, were invited to participate in the study, 9,451 of whom were included in the analysis. Specimens were tested centrally by LBC, the AHPV test, and the HC2 test, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all HR-HPV-positive samples. Test characteristics were calculated based on histological review. As a result, we identified 90 women with cervical intraepithelial neoplasia grade 2+ (CIN2+), including 43 women with CIN3+. Sensitivity differences between the AHPV test and the HC2 test in detecting CIN2+ (P = 0.180) or CIN3+ (P = 0.0625) lesions were statistically nonsignificant. Of three CIN3 cases that were missed with the AHPV test, two cases presented lesion-free cones and one had a non-HR HPV67 infection. The specificity (<CIN2) and positive predictive value (CIN2+) of the AHPV test were significantly higher (both P < 0.001) than those of the HC2 test. The overall agreement between the tests was substantial (κ = 0.77). Finally, we present results for several possible triage strategies, based on the primary screening test being either the AHPV test or the HC2 test. In summary, the AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be used in primary cervical cancer screening for women ≥30 years of age.

Original languageEnglish
Pages (from-to)2509-16
Number of pages8
JournalJournal of Clinical Microbiology
Volume53
Issue number8
Early online date20 Jul 2015
DOIs
Publication statusPublished - Aug 2015

Keywords

  • Adult
  • Cervical Intraepithelial Neoplasia
  • Cytological Techniques
  • DNA, Viral
  • Early Detection of Cancer
  • Female
  • Genotype
  • Germany
  • Histocytochemistry
  • Humans
  • Middle Aged
  • Molecular Diagnostic Techniques
  • Papillomaviridae
  • Papillomavirus Infections
  • Precancerous Conditions
  • Predictive Value of Tests
  • RNA, Messenger
  • RNA, Viral
  • Sensitivity and Specificity
  • Comparative Study
  • Evaluation Studies
  • Journal Article
  • Research Support, Non-U.S. Gov't

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Iftner, T., Becker, S., Neis, K.-J., Castanon, A., Iftner, A., Holz, B., Staebler, A., Henes, M., Rall, K., Haedicke, J., von Weyhern, C. H., Clad, A., Brucker, S., & Sasieni, P. (2015). Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany. Journal of Clinical Microbiology, 53(8), 2509-16. https://doi.org/10.1128/JCM.01013-15