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[用于预防宫颈癌的检测人乳头瘤病毒(HR HPV)DNA的分子检测应用指南。PGS(PTG)和NCLD(KIDL)专家声明]

[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)].

出版信息

Ginekol Pol. 2013 May;84(5):395-9.

PMID:23819408
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 ofASCUS. 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.

摘要

在几乎所有宫颈癌样本中都能检测到高危型人乳头瘤病毒(HPV-HR)的DNA。大多数HPV感染是短暂的,有些会持续存在并导致肿瘤形成甚至宫颈癌病变。宫颈癌筛查项目旨在检测早期癌前病变,这应能降低癌症发病率和死亡率,并降低诊断和治疗成本。最有效的筛查项目是使用细胞学和HPV检测的项目。事实证明,用这种方法进行筛查可降低宫颈癌的发病率和死亡率。21至29岁女性:不应使用HPV检测来筛查21至29岁的女性,无论是单独检测还是与细胞学联合检测。对于这组女性,在诊断意义不明确的不典型鳞状细胞(ASCUS)时,建议进行DNA HPV HR检测。DNA HPV检测呈阳性且患有ASCUS的女性应转诊至阴道镜检查。30至65岁女性:不建议单独进行HPV检测筛查。女性应每5年进行一次细胞学和HPV联合检测,或每3年单独进行一次细胞学检测(可接受)。DNA HPV HR /阳性,巴氏涂片检查/阴性:推荐两种选择。选择1:进行为期12个月的随访并再次检测(巴氏涂片检查和DNA HPV HR检测)。选择2:检测HPV16或HPV16/18基因型。如果HPV16或HPV16/18呈阳性:转诊至阴道镜检查;如果HPV16或HPV16/18呈阴性:进行为期12个月的随访并再次联合检测。DNA HPV HR /阴性,非典型鳞状细胞-不能明确意义(ASC-US):建议在12个月后重复进行细胞学检查。65岁以上女性:在之前充分的阴性筛查结果之后,不建议进行筛查。有宫颈上皮内瘤变2级(CIN2)或更严重诊断病史 的女性应继续进行常规筛查至少20年。接种HPV疫苗的女性:遵循特定年龄的建议(与未接种疫苗的女性相同)。宫颈癌筛查中DNA HPV HR检测的要求:宫颈癌筛查中使用的DNA HPV检测应尽可能检测出14种HPV HR型(16、18、31、33、35(此处原文有误,推测为35,实际应为34)、39、45、51、52、56、58、59、66和68)以及HPV 16/18的基因分型。候选检测方法应能控制DNA HPV的纯化和扩增过程,并防止污染。对CIN 2及以上病变的临床敏感性应不低于90%。HPV检测和标本采集系统应符合医疗器械相关法案的要求。

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