第二代杂交捕获法诊断宫颈高度病变的临床评价  

Evaluation of the diagnostic accuracy of HC2 in detecting high-grade cervical intraepithelial neoplasia

作　　者：肖克林[1] 吴丽娟[1] 郑有为[2] 钱靖琳[2] 梅平[2] 王丁[2] 周克元[3] 

机构地区：[1]深圳市宝安区妇幼保健院检验科,广东深圳518133 [2]广东省人民医院病理医学部,广东广州510080 [3]广东医学院生物化学与分子生物学教研室,广东湛江524023

出　　处：《检验医学》2009年第6期409-412,共4页Laboratory Medicine

摘　　要：目的评价第2代杂交捕获法(HC2)检测13种高危型人乳头瘤病毒(HPV)用于诊断宫颈高度病变的效能。方法利用HC2检测292位妇女宫颈上皮细胞13种高危型HPV感染状况,以组织病理学检测结果为金标准评价HC2诊断宫颈高度病变[≥宫颈上皮内瘤变2级(C IN2)]的效能。结果≥C IN2组妇女13种高危型HPV感染率为95.56%(43/45),<C IN2组为66.40%(164/247),两组间差异有统计学意义(2χ=15.68,P<0.001)。HC2诊断宫颈高度病变的敏感性为95.56%,特异性为33.60%,阳性预测值为20.77%,阴性预测值为97.65%,阳性似然比为1.44,阴性似然比为0.13。受试者工作特征(ROC)曲线分析发现,HC2诊断宫颈高度病变时曲线下面积为0.64,最佳诊断值为3.46 pg/mL,此时方法的敏感性为93.30%,特异性为42.10%。结论宫颈高度病变与13种高危型HPV感染有关。HC2具有较高的敏感性和阴性预测值,但特异性和阳性预测值较低,临床上若用于宫颈高度病变的确诊,应与其他特异性较高的方法结合以提高其准确性。Objective To evaluate the diagnostic accuracy of hybrid capture 2 （HC2） in detecting high-grade cervical intraepithelial neoplasia （CIN）. Methods 292 women were enrolled and their cervical squamous cell specimens were collected for detecting 13 high-risk Human papillomavirus （HPV） genotypes by HC2, and the diagnostic accuracy of HC2 in detecting high-grade CIN （ t〉 CIN2 ） was analyzed using histopathology result as standard. Results 66.40% （164/247） women of histopathologically confirmed 〈 CIN2 and 95.56% （43/45） women of histopathologically confirmed ≥CIN2 were infected by 13 high risk HPV, there was significant difference between them（χ2 = 15.68, P 〈 0. 001 ）. The sensitivity, specificity, positive predictive value, negative predictive value, positive likelihook ratio and negative likelihook ratio of HC2 were 95.56% , 33.60% , 20.77% ,97.65% , 1.44 and 0.13, respectively. Area under receiver operator characteristic （ROC） curve was 0.64, the optimal diagnostic value was 3.46 pg/mL, the sensitivity and specificity were 93.30% and 42.10% in the point, respectively. Conclusions There is significant correlation between HPV infection and high-grade CIN. HC2 has good sensitivity and negative predictive value in screening high-grade CIN, but the specificity and positive predictive value are weak. It must be combined with other methods to improve its accuracy in ≥CIN2 diagnosis.

关 键 词：第2代杂交捕获法 敏感性 特异性 受试者工作特征曲线 人乳头瘤病毒 宫颈高度病变 

分 类 号：R446.5[医药卫生—诊断学]