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HPV self-sampling in CIN2+ detection: sensitivity and specificity of different RLU cut-off of HC2 in specimens from 786 women
  1. F Bottari1,
  2. S Igidbashian2,
  3. S Boveri2,
  4. A Tricca1,
  5. C Gulmini1,
  6. M Sesia1,
  7. N Spolti2,
  8. M Sideri,
  9. F Landoni2,
  10. M T Sandri1
  1. 1Division of Laboratory Medicine, European Institute of Oncology, Milan, Italy
  2. 2Preventive Gynecology Unit, European Institute of Oncology, Milan, Italy
  1. Correspondence to Dr F Bottari, European Institute of Oncology, via Ripamonti 435, Milan 20141, Italy; fabio.bottari{at}ieo.it

Abstract

Aims Mortality for cervical cancer varies between the different regions of the world, with high rates in low-income countries where screening programmes are not present and organised. However, increasing screening coverage is still a priority in all countries: one way to do that is to base screening on self-sampled screening. The success of a self-sampling screening strategy depends on capacity to recruit unscreened women, on the performance and acceptability of the device and on the clinical performance of the high-risk human papillomavirus (HPV) test.

Methods This study based on 786 enrolled women investigates the best cut-off value of Hybrid Capture 2 HPV test (HC2) for self-sampled specimens in terms of sensitivity and specificity.

Results In this population, we found that the sensitivity and the specificity for cervical intraepithelial neoplasia grade 2 or more detection of HC2 performed on self-sampled specimens were 82.5% and 82.8%, respectively considering the relative light units (RLU) cut-off value of 1. Increasing the cut-off value the sensitivity decreases and the specificity raises and the best area under the curve for the RLU cut-off value is 1.

Conclusions Our results confirm that the cut-off value of 1 suggested by Qiagen for PreservCyt specimen is the best cut-off value also for self-sampled specimens.

  • HPV
  • CERVICAL CANCER
  • LABORATORY TESTS

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