第二代杂交捕获法诊断宫颈高度病变的临床评价

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（CIN2）]的效能。结果≥CIN2组妇女13种高危型HPV感染率为95．56％（43／45），〈CIN2组为66．40％（164／247），两组间差异有统计学意义（X2：15．68，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3．46pg／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。

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

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.