Department of Biomedical and Health Informatics, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri, United States of America.
PLoS One. 2012;7(7):e39101. doi: 10.1371/journal.pone.0039101. Epub 2012 Jul 6.
Women with low grade squamous intraepithelial lesions (LSIL) at cervical cancer screening are currently referred for further diagnostic work up despite 80% having no precancerous lesion. The primary purpose of this study is to measure the test characteristics of 3q26 chromosome gain (3q26 gain) as a host marker of carcinogenesis in women with LSIL. A negative triage test may allow these women to be followed by cytology alone without immediate referral to colposcopy.
A historical prospective study was designed to measure 3q26 gain from the archived liquid cytology specimens diagnosed as LSIL among women attending colposcopy between 2007 and 2009. 3q26 gain was assessed on the index liquid sample; and sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were measured at immediate triage and at 6-16 months after colposcopic biopsy. The sensitivity of 3q26 gain measured at immediate triage from automated and manually reviewed tests in 65 non-pregnant unique women was 70% (95% CI: 35, 93) with a NPV of 89% (95% CI: 78, 96). The sensitivity and NPV increased to 80% (95% CI: 28, 99) and 98% (95% CI: 87, 100), respectively, when only the automated method of detecting 3q26 gain was used.
3q26 gain demonstrates high sensitivity and NPV as a negative triage test for women with LSIL, allowing possible guideline changes to routine surveillance instead of immediate colposcopy. Prospective studies are ongoing to establish the sensitivity, specificity, PPV and NPV of 3q26 gain for LSIL over time.
目前，对于宫颈癌筛查中低度鳞状上皮内病变（LSIL）的女性，尽管 80%的患者没有癌前病变，但仍会被转诊进行进一步的诊断性检查。本研究的主要目的是测量 3q26 染色体获得（3q26 增益）作为 LSIL 女性致癌作用的宿主标志物的检测特征。阴性分流试验可能使这些女性仅通过细胞学检查进行随访，而无需立即转诊行阴道镜检查。
本研究设计了一项历史前瞻性研究，以测量 2007 年至 2009 年期间在阴道镜检查中诊断为 LSIL 的女性存档的液基细胞学标本中的 3q26 增益。在索引液样本中评估 3q26 增益；并在即时分流和阴道镜活检后 6-16 个月测量其敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。在 65 名非妊娠独特女性的自动和手动复查试验中，即时分流时 3q26 增益的检测敏感性为 70%（95%CI：35，93），NPV 为 89%（95%CI：78，96）。当仅使用自动检测 3q26 增益的方法时，敏感性和 NPV 分别增加到 80%（95%CI：28，99）和 98%（95%CI：87，100）。
3q26 增益作为 LSIL 女性的阴性分流试验，具有较高的敏感性和 NPV，可能会改变常规监测的指南，而不是立即进行阴道镜检查。正在进行前瞻性研究以确定 3q26 增益随时间对 LSIL 的敏感性、特异性、PPV 和 NPV。
