Guidelines for application of molecular tests identyfying HR HPV DNA in the prevention of cervical cancer. Statement of experts from PGS (PTG) and NCLD (KIDL)

Abstract

DNA from high risk types of human papillomavirus (HPV-HR) is detected in virtually all cervical cancer samples. Most of HPV infections are transient, some persist and lead to development of neoplastics or even cervical cancer lesions. Cervical cancer screening programs are designed to detect early precancerous changes, which should decrease the cancer morbidity and mortality and reduce the costs of diagnosis and treatment. The most effective are screening programs that use cytological and HPV testing. Screening with this method are proven to reduce both the incidence and mortality from cervical cancer. Women aged 21-29 years HPV testing should not be used to screen women aged 21-29 years, either as a stand-alone test or as a cotest with cytology. DNA HPV HR testing in this group of women is recommended in diagnostics of ASCUS. Women DNA HPV positive with ASCUS should be referred to colposcopy. Women aged 30-65 years Screening by HPV testing alone is not recommended. Women should be screened with cytology and HPV testing every 5 years or cytology alone every 3 years (acceptable). DNA HPV HR /+/, PAP /-/ Two options are recommended. Option 1: 12-months follow-up with contesting (PAP and DNA HPV HR tests). Option 2: Test for HPV16 or HPV16/18 genotypes. If HPV16 or HPV16/18 positive: refer to colposcopy. If HPV16 or HPV16/18 negative:12-months follow-up with cotesting. DNA HPV HR /-/, ASC-US Repetition of cytology in 12 moths is recommended. Women aged >65 years No screening is recommended following adequate negative prior to screening. Women with a history of CIN2 or a more severe diagnosis should continue routine screening for at least 20 years. Women HPV vaccinated Follow age-specific recommendations (same as unvaccinated women). Requirements of DNA HPV HR tests in cervical screening The DNA HPV tests used in cervical screening should detect as much as possible of 14 HPV HR types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 i 68) and genotyping HPV 16/18. Candidates’ tests should have control of DNA HPV purification and amplification processes and be preserved against contaminations. Clinical sensitivity for CIN 2 + should be no less than 90%. HPV tests and specimen collection system should fulfill the requirements of the act on medical devices.