Evaluation of HPV Molecular Tests in Primary Screening for Cervical Cancer in Brazil

Abstract

Background: Incorporation of HPV tests into cervical cancer screening programs may be advantageous over conventional cytology, especially in developing nations, where the largest burden of cervical cancer is observed. Objectives: To conduct an evaluation of commercially available molecular HPV tests in Brazilian women. Study design: Two groups were recruited: group A was composed of 511 women referred to the clinics because of a previous abnormal Pap test while group B * Corresponding author. J. E. Levi et al. 471 consisted of 2464 subjects under routine screening. Cervical samples were collected using Sure-Path liquid cytology (LBC) device, and split into aliquots which were submitted to molecular testing by Hybrid Capture and cobas HPV. Colposcopy and biopsies were made according to the standard guidelines, directed by cytological diagnosis. Results: Prevalence of HSIL was 5.97% and 0.7% in Group A and B respectively. High-Risk HPV DNA was found in about 9% of group B women, while in group A this frequency was 24%. Having CIN3+ as the study end-point, the negative pre-dictive values for molecular methods were above 99.8%. All "in-situ" and invasive cervical carci-nomas were detected by both HPV nucleic acid assays. Conclusion: Use of HPV DNA testing was feasible and highly sensitive in cancer screening settings of Brazil.