CAJ | 학술논문

目的探讨FTA Elute(R)指示卡(英国GE公司)联合第二代杂交捕获技术(hybrid capture 2,HC2)在人群中开展宫颈癌筛查的有效性.方法 2012年5-6月,选择江西省铜鼓县参与“低成本子宫颈癌分子技术筛查方法研究(LCMCCSS)”项目复查的412名25 ～ 65岁妇女纳入研究.以病理结果为金标准,分别评价医师采样和自我采样时,FTA Elute(R)指示卡和液体管联合HC2检测方法筛查宫颈上皮内瘤变2级及以上病变(CIN2+)的有效性.结果医师采样时,在维持液体管检测灵敏度(12/13)的基础上,FTA Elute(R)指示卡会大幅提高检测的特异度,特异度由69.5％(266/383)增长到77.8％ (298/383)(P＜0.001).自我采样时,FTA Elute(R)指示卡虽会提高检测的特异度,特异度由62.3％(238/382)增长到75.7％(289/382)(P＜0.001),但其灵敏度由液体管的10/13降为8/13(P=0.625).对于FTA Elute(R)指示卡采样标本,医师和自我采样一致率为86.1％(340/395);对于液体管采样标本,医师和自我采样一致率为79.5％(314/395).医师通过FTA Elute(R)指示卡采样,筛查效果最优(受试者工作特征曲线下面积=0.898,95％ CI:0.838 ～0.958).结论 FTA Elute(R)指示卡联合HC2法检测筛查宫颈癌具有较好的有效性,通过进一步大样本验证,有望成为卫生资源匮乏地区宫颈癌筛查的有效手段.
목적 탐토FTA Elute(R)지시잡(영국GE공사)연합제이대잡교포획기술(hybrid capture 2,HC2)재인군중개전궁경암사사적유효성.방법 2012년5-6월,선택강서성동고현삼여“저성본자궁경암분자기술사사방법연구(LCMCCSS)”항목복사적412명25 ～ 65세부녀납입연구.이병리결과위금표준,분별평개의사채양화자아채양시,FTA Elute(R)지시잡화액체관연합HC2검측방법사사궁경상피내류변2급급이상병변(CIN2+)적유효성.결과 의사채양시,재유지액체관검측령민도(12/13)적기출상,FTA Elute(R)지시잡회대폭제고검측적특이도,특이도유69.5％(266/383)증장도77.8％ (298/383)(P＜0.001).자아채양시,FTA Elute(R)지시잡수회제고검측적특이도,특이도유62.3％(238/382)증장도75.7％(289/382)(P＜0.001),단기령민도유액체관적10/13강위8/13(P=0.625).대우FTA Elute(R)지시잡채양표본,의사화자아채양일치솔위86.1％(340/395);대우액체관채양표본,의사화자아채양일치솔위79.5％(314/395).의사통과FTA Elute(R)지시잡채양,사사효과최우(수시자공작특정곡선하면적=0.898,95％ CI:0.838 ～0.958).결론 FTA Elute(R)지시잡연합HC2법검측사사궁경암구유교호적유효성,통과진일보대양본험증,유망성위위생자원궤핍지구궁경암사사적유효수단.
Objective To evaluate the effectiveness of FTA Elute(R) Cartridge (GE healthcare,Kent,UK) in combination with hybrid capture 2 (HC2)testing for cervical cancer screening.Methods From May to June 2012,412 women aged 25 to 65 years in Jiangxi Tonggu were enrolled in the study.We used pathological outcome as the gold standard,and the accuracy of the FTA card in combination with HC2 testing was investigated from both physician-and self-sampling,respectively.Results Physician sampling using the FTA card in combination with HC2 testing showed a comparable sensitivity(12/13) with the liquid based medium,but a higher specificity 69.5％ (266/383) vs (77.8％,298/383) (P ＜ 0.001).When self sampling method was used,the sensitivity and spccificity of using the FTA card in combination with HC2 testing with liquid based medium was 10/13 vs 8/13 (P =0.625) and (62.3％,238/382) vs (75.7％,289/382) (P ＜ 0.001).The agreement of detection results for HC2 between FTA and liquid-based sampling medium was 86.1％ (340/395) and 79.5％ (314/395).For physician-collected samples used for HC2 testing to detect CIN2 +,the accuracy of the FTA card was superior to that of the liquid-based medium (area under the receiver operating characteristic curve (AUC) =0.898,95％ CI:0.838-0.958).Conclusion FTA Elute(R) cartridge in combination with HC2 testing is a promising method of specimen transport for cervical cancer screening programs with a good precision.With further optimization,it could become an effective method for cervical cancer screening in various economic levels of areas.