女性生殖道不同取样标本中人乳头瘤病毒DNA检测的筛查效果评价  

Evaluation of screening performance of HPV DNA test on specimens from different sites of thefemale genital tract

作　　者：张韶凯[1] 康乐妮[1] 刘彬[1] 崔剑峰[1] 陈凤[1] 刘新伏[1] 王红[1] 陈汶[1] 

机构地区：[1]北京协和医学院中国医学科学院肿瘤医院肿瘤研究所流行病室,100021

出　　处：《中华肿瘤杂志》2014年第5期389-393,共5页Chinese Journal of Oncology

摘　　要：目的探讨女性生殖道不同取样标本中人乳头瘤病毒（HPV）DNA检测的筛查效果。方法采用第二代杂交捕获技术（HC2）检测806例受试者宫颈、上阴道、下阴道和自体取样标本的HPVDNA，对其中489例受试者的所有标本进行了线性阵列（LA）HPVDNA分型检测，分析自体取样标本检出宫颈上皮内瘤变2级（CIN2）及以上病变的能力。结果HC2检测宫颈、上阴道、下阴道和自体取样标本HPVDNA预测CIN2及以上病变能力的ROC曲线下面积分别为0．902、0．793、0．769和0．773，自体取样标本与宫颈标本比较，曲线下面积差异有统计学意义（P〈0．001）。以RLU／CO=1．00为诊断临界值，HC2检测官颈、上阴道、下阴道和自体取样标本HPVDNA预测CIN2及以上病变的灵敏度分别为98．0％、91．8％、83．7％和81．6％，自体取样标本与宫颈标本比较，灵敏度差异有统计学意义（P=0．008）。当降低自检标本HC2检测的诊断临界值，其灵敏度增加，但增加量小于特异度减小量。采用LA检测自体取样标本检出CIN2及以上病变的灵敏度为95．7％，采用HC2检测宫颈标本的灵敏度为97．9％，差异无统计学意义（P〉0．05）。结论HC2检测自体取样标本检出CIN2及以上病变的诊断价值低于宫颈标本，降低诊断临界值并不能有效改善自体取样标本的诊断价值；采用LAHPVDNA检测技术能显著提高自体取样标本的筛查诊断效果。Objective To evaluate the diagnostic performance of different specimens for detecting CIN2^＋, and to find the solution of the problem that why the performance of self-collected specimen is worse than cervical specimen collected by physician. Methods The cervix, lower 1/3 vagina, upper 1/3 vagina and self-collected specimens from each of the 806 women who took part in this multi-center screening program from May 2006 to April 2007 were tested by hybrid capture 2 （HC2） technique. The diagnostic performance of HC2 on the four specimens for detecting CIN2 ~ lesions was calculated. Linear array was performed on the four specimens from 489 out of the 806 women and the diagnostic performance of linear array on the four specimens for detecting CIN2 ~ lesions was also calculated. Z test was used to compare the area under ROC and McNemar or X2 test was used to compare the sensitivity and specificity of different specimens. Results The area under ROC of the cervix, 1/3 upper vagina, 1/3 lower vagina and self- collected samples testing by HC2 for detecting CIN2^ ＋ lesions were 0. 902, 0. 793, 0. 769 and 0. 773, respectively （P 〈0.001 ）. Using 1 RUL/CO as the cut-point of HC2, the sensitivity of the cervix, upper vagina, lower vagina and self-collected samples were 98.0% , 91.8%, 83.7% and 81.6%. Compared with the cervical specimen, the sensitivity of self-collected specimen for detecting CIN2^ ＋ lesions was significantly lower （P = 0.008 ）. Lowering the cutoff value for HC2 test could improve the sensitivity of self-collected specimen, but it significantly compromised the specificity. The sensitivity of self-collected specimen tested by linear array for detecting CIN2^＋ lesions was 95.7% and it was not significantly different compared with the sensitivity of cervical specimen （97.9%） tested by HC2. Condusions The performance of self-collected specimen tested by HC2 for detecting CIN2^＋ lesions is lower than that of physician-collected cervical specimen, and lowering the cutoff value can＇t improv

关 键 词：宫颈肿瘤 人乳头瘤病毒 DNA 普查 预测 诊断 

分 类 号：R737.33[医药卫生—肿瘤]