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第二代杂交捕获法诊断宫颈高度病变的临床评价
引用本文:肖克林,吴丽娟,郑有为,钱靖琳,梅平,王丁,周克元.第二代杂交捕获法诊断宫颈高度病变的临床评价[J].检验医学,2009,24(6):409-412.
作者姓名:肖克林  吴丽娟  郑有为  钱靖琳  梅平  王丁  周克元
作者单位: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
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(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。

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

Evaluation of the diagnostic accuracy of HC2 in detecting high-grade cervical intraepithelial neoplasia
XIAO Kelin,WU Lijuan,ZHENG Youwei,QIAN Jinglin,MEI Ping,WANG Ding,ZHOU Keyuan.Evaluation of the diagnostic accuracy of HC2 in detecting high-grade cervical intraepithelial neoplasia[J].Laboratory Medicine,2009,24(6):409-412.
Authors:XIAO Kelin  WU Lijuan  ZHENG Youwei  QIAN Jinglin  MEI Ping  WANG Ding  ZHOU Keyuan
Institution:XIAO Kelin, WU Lijuan, ZHENG Youwei, QIAN Jinglin, MEI Ping, WANG Ding, ZHOU Keyuan(1. Department of Clinical Laboratory, Boo'an Maternity and Child Health Hospital, Guangdong Shenzhen 518133, China; 2. Department of Pathology Medicine, Guangdong Provincial People's Hospital, Guangdong Guangzhou 510080, China ; 3. Department of Biochemistry, Guangdong Medical College, Guangdong Zhanjiang 524023, China)
Abstract: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.
Keywords:Hybrid capture 2  Sensitivity  Specificity  Receiver operator characteristic curve  Human papillomavirus  Cervical intraepithelial neoplasia
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