PDF(Pubmed)
Abstract：
BACKGROUND: Each high-risk HPV genotype has different oncogenic potential, and the risk of CIN3+ varies according to genotype. We evaluated the performance of different strategies of HPV-positivity triage combining cytology, p16/ki67 dual staining (DS), and extended genotyping.
METHODS: Samples from 3180 consecutive women from the NTCC2 study (NCT01837693) positive for HPV DNA at primary screening, were retrospectively analyzed by the BD Onclarity HPV Assay, which allows extended genotyping. Genotypes were divided into three groups based on the risk of CIN3+. HPV DNA-positive women were followed up for 24 months or to clearance.
RESULTS: Combining the three groups of genotypes with cytology or DS results we identify a group of women who need immediate colposcopy (PPV for CIN3+ from 7.8 to 20.1%), a group that can be referred to 1-year HPV retesting (PPV in those HPV-positive at retesting from 2.2 to 3.8), and a group with a very low 24-month CIN3+ risk, i.e. 0.4%, composed by women cytology or DS negative and positive for HPV 56/59/66 or 35/39/68 or negative with the Onclarity test, who can be referred to 3-year retesting.
CONCLUSIONS: Among the baseline HPV DNA positive/cytology or DS negative women, the extended genotyping allows to stratify for risk of CIN3+, and to identify a group of women with a risk of CIN3+ so low in the next 24 months that they could be referred to a new screening round after 3 years.
BACKGROUND: Italian Ministry of Health (grant number RF-2009-1536040). Hologic-Genprobe, Roche Diagnostics, and Becton & Dickinson provided financial and non-financial support.
METHODS: Samples from 3180 consecutive women from the NTCC2 study (NCT01837693) positive for HPV DNA at primary screening, were retrospectively analyzed by the BD Onclarity HPV Assay, which allows extended genotyping. Genotypes were divided into three groups based on the risk of CIN3+. HPV DNA-positive women were followed up for 24 months or to clearance.
RESULTS: Combining the three groups of genotypes with cytology or DS results we identify a group of women who need immediate colposcopy (PPV for CIN3+ from 7.8 to 20.1%), a group that can be referred to 1-year HPV retesting (PPV in those HPV-positive at retesting from 2.2 to 3.8), and a group with a very low 24-month CIN3+ risk, i.e. 0.4%, composed by women cytology or DS negative and positive for HPV 56/59/66 or 35/39/68 or negative with the Onclarity test, who can be referred to 3-year retesting.
CONCLUSIONS: Among the baseline HPV DNA positive/cytology or DS negative women, the extended genotyping allows to stratify for risk of CIN3+, and to identify a group of women with a risk of CIN3+ so low in the next 24 months that they could be referred to a new screening round after 3 years.
BACKGROUND: Italian Ministry of Health (grant number RF-2009-1536040). Hologic-Genprobe, Roche Diagnostics, and Becton & Dickinson provided financial and non-financial support.
摘要：
背景：每种高危HPV基因型具有不同的致癌潜力，CIN3+的风险因基因型而异。我们评估了HPV阳性分诊结合细胞学的不同策略的性能，p16/ki67双重染色（DS），和扩展的基因分型。
方法：来自NTCC2研究（NCT01837693）初筛HPVDNA阳性的3180名连续女性的样本，通过BD通明度HPV检测进行回顾性分析，这允许扩展的基因分型。根据CIN3+的风险将基因型分为三组。HPVDNA阳性的女性随访24个月或清除。
结果：将三组基因型与细胞学或DS结果结合起来，我们确定了一组需要立即进行阴道镜检查的女性（对于CIN3的PPV从7.8％到20.1％），可以进行1年HPV再检测的组（HPV阳性的PPV在2.2至3.8的再检测中），和一个24个月CIN3+风险非常低的群体，即0.4%，由女性细胞学或DS阴性和HPV56/59/66或35/39/68阳性或Oncaricity测试阴性组成，可以参考3年的重新测试。
结论：在基线HPVDNA阳性/细胞学或DS阴性的女性中，扩展的基因分型允许对CIN3+的风险进行分层，并确定一组在未来24个月内CIN3+风险如此之低的女性，以至于她们可以在3年后被转诊到新一轮筛查。
背景：意大利卫生部（批准号RF-2009-1536040）。Hologic-Genprobe,罗氏诊断,Becton&Dickinson提供了财务和非财务支持。
方法：来自NTCC2研究（NCT01837693）初筛HPVDNA阳性的3180名连续女性的样本，通过BD通明度HPV检测进行回顾性分析，这允许扩展的基因分型。根据CIN3+的风险将基因型分为三组。HPVDNA阳性的女性随访24个月或清除。
结果：将三组基因型与细胞学或DS结果结合起来，我们确定了一组需要立即进行阴道镜检查的女性（对于CIN3的PPV从7.8％到20.1％），可以进行1年HPV再检测的组（HPV阳性的PPV在2.2至3.8的再检测中），和一个24个月CIN3+风险非常低的群体，即0.4%，由女性细胞学或DS阴性和HPV56/59/66或35/39/68阳性或Oncaricity测试阴性组成，可以参考3年的重新测试。
结论：在基线HPVDNA阳性/细胞学或DS阴性的女性中，扩展的基因分型允许对CIN3+的风险进行分层，并确定一组在未来24个月内CIN3+风险如此之低的女性，以至于她们可以在3年后被转诊到新一轮筛查。
背景：意大利卫生部（批准号RF-2009-1536040）。Hologic-Genprobe,罗氏诊断,Becton&Dickinson提供了财务和非财务支持。
