Comparison of different commercial methods for HPV detection in follow-up cytology after ASCUS/LSIL, prediction of CIN2–3 in follow up biopsies and spontaneous regression of CIN2–3
Highlights
► Amplicor and Cobas4800 detect HPV-DNA, PreTect HPV-Proofer and APTIMA HPV-mRNA. ► Amplicor, Cobas4800 and APTIMA are comparable, PreTect HPV-Proofer less sensitive. ► Spontaneous regression of CIN2–3 was not predicted by either method.
Section snippets
Background
Cytology screening is useful to detect cervical intraepithelial neoplasia (CIN) and cancer [1]. Interpretive variability and low sensitivity are problematic for atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL) [2], [3], [4], [5], [6]. Human Papilloma Virus (HPV) testing is widely performed [7], [8], [9], [10], as persistent carcinogenic HPV infection is necessary for cervical neoplasia [11], [12]. Much attention is paid to use
Ethics
The study has been approved by the Regional Medical Ethics Committee of Health West, Norway (2010/2550).
Patient material
Originally, 550 cases with a referral = index cytology diagnosis of ASCUS (n = 371), LSIL (n = 157), high-grade intraepithelial lesion (HSIL, n = 10), atypical cells suspect for high-grade lesion (ASCH, n = 5), atypical glandular cells of uncertain significance (AGUS, n = 2) and cases with no referral cytology (n = 5) were diagnosed in the Norwegian population-based Cervical Cancer Screening Program (
Results
Eighty percent of the women were > 30 years, the median age was 37, mean 40, Range: (25–69) years.
Discussion
The detection of hrHPV and the sensitivity to predict CIN2–3 by the Amplicor, Cobas4800 and APTIMA show almost perfect agreement, while Proofer differs significantly from the other tests, with considerably fewer HPV positives and lower sensitivity. The partial genotyping results of the PreTect HPV Proofer showed many discrepancies with the LA Genotyping test, while the Cobas4800 had good agreement with the LA.
A number of the samples which were HPV positive by the DNA tests were negative by the
Conflict of interest statement
We hereby declare that none of the authors or the study sponsors has conflicts of interest regarding the study design, collection of data, analyzing and interpretation of data, writing the report or in the decision to submit the report for publication. None of the authors has any financial interest in publishing these data, nor any financial or advisory relationship with a company producing the equipment or chemicals described in this article.
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