CAJ | 학술논문

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HPV DNA，对其中489例受试者的所有标本进行了线性阵列（ LA） HPV DNA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HPV DNA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检测宫颈、上阴道、下阴道和自体取样标本HPV DNA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LA HPV DNA检测技术能显著提高自体取样标本的筛查诊断效果。
목적：탐토녀성생식도불동취양표본중인유두류병독（ HPV） DNA 검측적사사효과。방법채용제이대잡교포획기술（ HC2）검측806례수시자궁경、상음도、하음도화자체취양표본적HPV DNA，대기중489례수시자적소유표본진행료선성진렬（ LA） HPV DNA분형검측，분석자체취양표본검출궁경상피내류변2급（ CIN2）급이상병변적능력。결과 HC2검측궁경、상음도、하음도화자체취양표본HPV DNA예측CIN2급이상병변능력적ROC곡선하면적분별위0．902、0．793、0．769화0．773，자체취양표본여궁경표본비교，곡선하면적차이유통계학의의（P＜0．001）。이RLU/CO＝1．00위진단림계치，HC2검측궁경、상음도、하음도화자체취양표본HPV DNA예측CIN2급이상병변적령민도분별위98．0％、91．8％、83．7％화81．6％，자체취양표본여궁경표본비교，령민도차이유통계학의의（P＝0．008）。당강저자검표본HC2검측적진단림계치，기령민도증가，단증가량소우특이도감소량。채용LA검측자체취양표본검출CIN2급이상병변적령민도위95．7％，채용HC2검측궁경표본적령민도위97．9％，차이무통계학의의（P＞0．05）。결론 HC2검측자체취양표본검출CIN2급이상병변적진단개치저우궁경표본，강저진단림계치병불능유효개선자체취양표본적진단개치；채용LA HPV DNA검측기술능현저제고자체취양표본적사사진단효과。
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 CIN 2 +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 CIN 2 +lesions was also calculated .Z test was used to compare the area under ROC and McNemar or χ2 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.Conclusions 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 improve its diagnostic performance .Using linear array as the HPV DNA test can significantly improve the screening diagnostic performance of self-collected specimens .