Option For Cervical Screening Research Articles

Equal prevalence of severe cervical dysplasia by HPV self-sampling and by midwife-collected samples for primary HPV screening: a randomised controlled trial.

HPV self-sampling is an option for cervical screening. The aim of this randomised study was to investigate the compliance, prevalence of HPV, and prevalence of severe dysplasia in a vaginal self-sampling group in comparison to cervical samples collected by midwives (control arm). The hypothesis was that there would be no difference between vaginal self-sampling and cervical sampling to find high-grade cervical dysplasia or cancer. Vaginal HPV self-sampling kits were sent by regular mail to 14 765 randomly selected women aged 30-64 years old in the screening programme. HPV-positive women were invited for a follow-up examination by their midwife in which they provided a cervical sample for cytological and HPV co-testing. The control arm consisted of 14 839 women who met the same inclusion criteria and were invited to have cervical sampling by midwives for primary HPV screening. All HPV samples were analysed by the Aptima HPV assay (Hologic Inc.). The participation rate was 33.5% in the self-sampling arm and 47.5% in the cervical sampling arm, (P < 0.0001). HPV was detected in 17.1% (95% confidence interval (CI), 16.1-18.23%) in the self-sampling arm and 4.5% (95% CI, 4.0-5.0%) in the cervical sampling arm. Histological, severe dysplasia was observed among 0.48% (95% CI, 0.3-0.72%) and 0.47% (95% CI, 0.3-0.66%) of the self-sampling and the cervical sampling groups, respectively. The self-sampling approach detects a similar proportion of severe dysplasia as regular screening. Thus, our study indicates that self-sampling could replace primary HPV screening of cervical samples.

A Study of Sensitivity of Visual Inspection of the Cervix with Acetic Acid in Cervical Cancer Screening

Visual inspection tests with 3–5% acetic acid (VIA) and/or Lugol’s iodine (VILI) appear to be a satisfactory alternative screening approach to cytology. These tests have been used since the 1990s, mainly in poor-resource settings. They are simple and cost-effective with relative ease of use and may be performed by different health care workers (physicians, nurse, midwives and technicians). Moreover, this approach does not require high technology or infrastructure and has been shown to reduce mortality in developing countries. The study was conducted on 1000 women recruited for gynaecology outpatient clinic at El Shatby Maternity University Hospital after giving of written consent. VIA was done by applying 3–5% acetic acid to the cervix using a cotton swab, checking the transformation zone carefully for any dense, non-movable aceto-white areas in the epithelium or any raised and thickened white plaques. The summary sensitivity and specificity of VIA were 84.1% and 53.8%, respectively; VIA was sensitive in detecting more severe outcome, although there was a slight loss in specificity. Apparent heterogeneity existed in sensitivity and specificity for VIA. High sensitivity of VIA was found when a combination of colposcopy and histology was used as disease confirmation, so it could be a good option for cervical screening in low-resource settings.

Is 58% sensitivity for detection of cervical intraepithelial neoplasia 3 and invasive cervical cancer optimal for cervical screening?

Recent Food and Drug Administration (FDA) approval of a Roche cobas human papillomavirus (HPV) test application as a first line primary cervical screening tool in women 25 and older introduces a new era of complex cervical screening choices. Perhaps the most surprising findings in Roche's supporting ATHENA trial data were the unexpectedly low verification bias-adjusted CIN3+ sensitivities documented by the FDA for both the proposed cobas HPV testing algorithm (58.26%) and Pap testing algorithm (42.63%). These unexpectedly low sensitivity estimates suggest intuitively that there is still considerable room for improvement in cervical screening, and available data from large systems point to routine cytology and HPV co-testing as offering the greatest protection against development of cervical cancer. Observational studies of large populations screened over time remain essential to document actual protection from development of cervical cancer with any new cervical screening options, as natural history studies and available data from large systems indicate that most CIN2/3 cases detected in short term clinical trials would not progress to invasive cervical cancer. Interpretation of ATHENA trial data and its application to routine clinical practice is further limited by published studies which document that a significant proportion of CIN2/3 biopsy diagnoses in the ATHENA trial could not be confirmed as accurate when evaluated with p16 immunohistochemistry and that cytology laboratory performance in the trial was notably suboptimal.