Lower cost strategies for triage of human papillomavirus DNA-positive women.

Lower cost strategies for triage of human papillomavirus DNA-positive women.
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DOI:
10.1002/ijc.28616
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发表时间:
2014-06-15
影响因子:
6.4
通讯作者:
Castle, Philip E.
Castle, Philip E.
中科院分区:
医学1区
文献类型:
--
作者:
Qiao, You-Lin;Jeronimo, Jose;Zhao, Fang-Hui;Schweizer, Johannes;Chen, Wen;Valdez, Melissa;Lu, Peter;Zhang, Xun;Kang, Le-Ni;Bansil, Pooja;Paul, Proma;Mahoney, Charles;Berard-Bergery, Marthe;Bai, Ping;Peck, Roger;Li, Jing;Chen, Feng;Stoler, Mark H.;Castle, Philip E.

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在低资源环境(LRS)使用人乳头瘤病毒(HPV)检测宫颈癌筛查将导致大量筛查阳性妇女。本分析比较了LRS中hpv阳性妇女检测宫颈癌前病变和癌症的不同分诊策略。这是一项基于人群的研究,研究对象是生活在中国的25-65岁女性(n = 7541)。每位妇女提供了一份自己收集的标本和两份临床收集的标本。通过两种HPV DNA检测方法(carehpv™和Hybrid Capture 2)对自己收集的和一种临床收集的样本进行检测;另一临床采集标本检测HPV16/18/45 E6蛋白。对CareHPV™阳性标本进行HPV16/18/45 DNA检测。HPV dna阳性的妇女接受醋酸目视检查(VIA),然后阴道镜活检评估。评估HPV DNA阳性妇女中检测宫颈上皮内瘤变3级或癌(CIN3+)的性能,采用不同的分诊策略:HPV16/18/45 E6或DNA检测,VIA,阴道镜印模,或更高的信号强度(≥10相对光单位/阳性对照[rlu/pc])。检出阳性的比例范围为:VIA为14.8-17.4%,阴道镜异常印痕为17.8-20.9%;HPV16/18/45 E6为7.9-10.5%;HPV16/18/45 DNA为23.4-28.4%;高信号强度(≥10 rlu/pc)为48.0-62.6%,取决于HPV检测/标本组合。随着诊断的严重程度,所有分诊试验的阳性增加。HPV16/18/45 DNA检测对CIN3+的敏感性约为70%,阳性预测值(PPV)约为25%。HPV16/18/45 E6检测灵敏度约为50%,CIN3+的PPV接近50%。HPV dna阳性妇女的不同分诊策略在阴道镜检查或治疗转诊百分比和流行CIN3+的敏感性方面提供了重要的权衡。careHPV™检测是一项用于低资源环境中妇女原发性宫颈癌筛查的新技术。然而,需要分诊策略来确定哪些hpv阳性妇女患宫颈癌前病变和癌症的风险最高。在这里,根据对发展中国家不同分诊策略绩效的评估,确定了根据当地需求和资源管理hpv阳性妇女的多种可行和负担得起的策略。对于HPV DNA检测呈阳性的妇女,不同的策略提供了阴道镜检查或治疗转诊百分比和宫颈上皮内瘤变3级或癌症(CIN3+)的敏感性的重要权衡。
Using human papillomavirus (HPV) testing for cervical cancer screening in lower-resource settings (LRS) will result in a significant number of screen-positive women. This analysis compares different triage strategies for detecting cervical precancer and cancer among HPV-positive women in LRS. This was a population-based study of women aged 25–65 years living in China (n = 7,541). Each woman provided a self-collected and two clinician-collected specimens. The self-collected and one clinician-collected specimen were tested by two HPV DNA tests—careHPV™ and Hybrid Capture 2; the other clinician-collected specimen was tested for HPV16/18/45 E6 protein. CareHPV™-positive specimens were tested for HPV16/18/45 DNA. HPV DNA-positive women underwent visual inspection with acetic acid (VIA) and then colposcopic evaluation with biopsies. The performance for detection of cervical intraepithelial neoplasia grade 3 or cancer (CIN3+) among HPV DNA-positive women was assessed for different triage strategies: HPV16/18/45 E6 or DNA detection, VIA, colposcopic impression, or higher signal strength (≥10 relative light units/positive control [rlu/pc]). The percent triage positive ranges were 14.8–17.4% for VIA, 17.8–20.9% for an abnormal colposcopic impression; 7.9–10.5% for HPV16/18/45 E6; 23.4–28.4% for HPV16/18/45 DNA; and 48.0–62.6% for higher signal strength (≥10 rlu/pc), depending on the HPV test/specimen combination. The positivity for all triage tests increased with severity of diagnosis. HPV16/18/45 DNA detection was approximately 70% sensitive and had positive predictive values (PPV) of approximately 25% for CIN3+. HPV16/18/45 E6 detection was approximately 50% sensitive with a PPV of nearly 50% for CIN3+. Different triage strategies for HPV DNA-positive women provide important tradeoffs in colposcopy or treatment referral percentages and sensitivity for prevalent CIN3+. The careHPV™ test is a novel technology for primary cervical cancer screening of women from lower-resource settings. However, triage strategies are needed to identify which HPV-positive women are at highest risk of cervical precancer and cancer. Here, multiple viable and affordable strategies to manage HPV-positive women depending on local requirements and resources are identified, based on evaluation of the performance of different triage strategies for developing countries. The different strategies for women who test positive for HPV DNA provide important tradeoffs in colposcopy or treatment referral percentages and sensitivity for cervical intraepithelial neoplasia grade 3 or cancer (CIN3+).
DOI: 10.1016/s1470-2045(10)70230-8
发表时间: 2010-11-01
期刊: LANCET ONCOLOGY
影响因子: 51.1
作者:
de Sanjose, Silvia;Quint, Wim G. V.;Xavier Bosch, F.
通讯作者: Xavier Bosch, F.
DOI: 10.1002/ijc.27563
发表时间: 2012-12-15
影响因子: 6.4
作者:
Gage, Julia C.;Ajenifuja, Kayode O.;Schiffman, Mark
通讯作者: Schiffman, Mark
DOI: 10.1056/nejmoa071430
发表时间: 2007-10-18
影响因子: 158.5
作者:
Mayrand, Marie-Helene;Duarte-Franco, Eliane;Franco, Eduardo L.
通讯作者: Franco, Eduardo L.
DOI: 10.1128/jcm.01315-10
发表时间: 2010-12-01
影响因子: 9.4
作者:
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通讯作者: Castle, Philip E.
DOI: 10.1016/s1470-2045(11)70188-7
发表时间: 2011-09-01
期刊: LANCET ONCOLOGY
影响因子: 51.1
作者:
Castle, Philip E.;Stoler, Mark H.;Behrens, Catherine M.
通讯作者: Behrens, Catherine M.