Comparison of Predictors for High-Grade Cervical Intraepithelial Neoplasia in Women with Abnormal Smears

Comparison of Predictors for High-Grade Cervical Intraepithelial Neoplasia in Women with Abnormal Smears
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DOI:
10.1158/1055-9965.epi-08-0508
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发表时间:
2008-11-01
影响因子:
3.8
通讯作者:
Cuzick, Jack
Cuzick, Jack
中科院分区:
医学3区
文献类型:
--
作者:
Szarewski, Anne;Ambroisine, Laurence;Cuzick, Jack

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背景:高危型人乳头瘤病毒(HPV)DNA的检测对高度恶性宫颈上皮内瘤变(CIN)的诊断具有比细胞学更高的敏感性,但特异性更低。这项研究比较了几种辅助试验在因细胞学异常而被阴道镜检查的人群中检测高级CIN的敏感性和特异性。方法:953名妇女参与研究。对液体PpresvCyt样本进行了多达七种检测:杂交捕获II(Digene)、Amplicor(罗氏)、保护HPV-Proofer(NorChip)、APTIMA HPV分析(Gen-Probe)、线性阵列(Roche)、临床阵列(Genomica)和CINTEC p16(INK4a)细胞学(MTM实验室)免疫细胞化学。敏感度、特异度和阳性预测值(PPV)基于中心复查后活检或治疗标本所见的最差组织学。结果:273例(28.6%)妇女在最差组织学上有高度恶性疾病(CIN2+),193例(20.2%)有CIN3+。对于CIN2+的检测,杂交捕获II的敏感性为99.6%,特异性为28.4%,PPV为36.1%。Amplicor的敏感性为98.9%,特异性为21.7%,PPV为33.5%。Proofer的敏感性为73.6%,特异性为73.1%,PPV为52.0%。APTIMA的敏感性为95.2%,特异性为42.2%,PPV为39.9%。细胞学检测CINTEC p16(INK4a)的敏感性为83.0%,特异性为68.7%,PPV为52.3%。线性阵列法的敏感性为98.2%,特异性为32.8%,阳性预测值为37.7%。临床芯片的敏感性为80.9%,特异性为37.1%,PPV为33.0%。(癌症流行病学生物标记物2008;17(11):3033-42)
Background: The detection of high-risk human papillomavirus (HPV) DNA provides higher sensitivity but lower specificity than cytology for the identification of high-grade cervical intraepithelial neoplasia (CIN). This study compared the sensitivity and specificity of several adjunctive tests for the detection of high-grade CIN in a population referred to colposcopy because of abnormal cytology.Methods: 953 women participated in the study. Up to seven tests were carried out on a liquid PreservCyt sample: Hybrid Capture II (Digene), Amplicor (Roche), PreTect HPV-Proofer (NorChip),APTIMA HPV assay (Gen-Probe), Linear Array (Roche), Clinical-Arrays (Genomica), and CINtec p16(INK4a) Cytology (mtm Laboratories) immunocytochemistry. Sensitivity, specificity, and positive predictive value (PPV) were based on the worst histology seen on either the biopsy or the treatment specimen after central review.Results: 273 (28.6%) women had high-grade disease (CIN2+) on worst histology, with 193 (20.2%) having CIN3+. For the detection of CIN2+, Hybrid Capture II had a sensitivity of 99.6%, specificity of 28.4%, and PPV of 36.1%. Amplicor had a sensitivity of 98.9%, specificity of 21.7%, and PPV of 33.5%. PreTect HPV-Proofer had a sensitivity of 73.6%, specificity of 73.1%, and PPV of 52.0%. APTIMA had a sensitivity of 95.2%, specificity of 42.2%, and PPV of 39.9%. CINtec p16(INK4a), Cytology had a sensitivity of 83.0%, specificity of 68.7%, and PPV of 52.3%. Linear Array had a sensitivity of 98.2%, specificity of 32.8%, and PPV of 37.7%. Clinical-Arrays had a sensitivity of 80.9%, specificity of 37.1%, and PPV of 33.0%. (Cancer Epidemiol Biomarkers Prev 2008;17(11):3033-42)