临床肿瘤学杂志
臨床腫瘤學雜誌
림상종류학잡지
CHINESE CLINICAL ONCOLOGY
2015年
1期
61-64
,共4页
肺癌%双显色试剂盒%神经元特异烯醇化酶( NSE)%细胞角蛋白21-1片段( CYFRA21-1)
肺癌%雙顯色試劑盒%神經元特異烯醇化酶( NSE)%細胞角蛋白21-1片段( CYFRA21-1)
폐암%쌍현색시제합%신경원특이희순화매( NSE)%세포각단백21-1편단( CYFRA21-1)
Lung cancer%Dual-color diagnostic ELISA kit%Neuron-specific enolase( NSE)%Cytokeratin 19 fragment ( CYFRA21-1)
目的：利用特异性与灵敏性较高的神经元特异烯醇化酶（ NSE）、细胞角蛋白21?1片段（ CYFRA21?1）肺癌相关标志物，研制肺癌双显色的体外联合诊断酶联免疫反应（ ELISA）试剂盒。方法将NSE、CYFRA21?1两种抗体按一定比例组合包被到酶标板的板底制成试剂盒。分别以NSE、CYFRA21?1抗原为研究对象，对包被液、包被时间、包被温度因素进行考察，以试剂盒的稳定性、灵敏度、准确性为指标进行结果分析。结果 NSE、CYFRA21?1肺癌双显色ELISA诊断试剂盒4℃放置时有效期为6个月。试剂盒灵敏度为83?8％（129／154），特异度为53?8％（57／106），准确性为71?5％（186／260），受试者工作特征曲线（ ROC）曲线下面积Az 为0?90，各项指标均较单独的NSE、CYFRA21?1明显提高。结论成功制备双显色ELISA肺癌诊断试剂盒，该试剂盒可提高肺癌检查的准确性、灵敏度，降低假阳性率，具有开发为新型肺癌诊断试剂盒的条件。
目的：利用特異性與靈敏性較高的神經元特異烯醇化酶（ NSE）、細胞角蛋白21?1片段（ CYFRA21?1）肺癌相關標誌物，研製肺癌雙顯色的體外聯閤診斷酶聯免疫反應（ ELISA）試劑盒。方法將NSE、CYFRA21?1兩種抗體按一定比例組閤包被到酶標闆的闆底製成試劑盒。分彆以NSE、CYFRA21?1抗原為研究對象，對包被液、包被時間、包被溫度因素進行攷察，以試劑盒的穩定性、靈敏度、準確性為指標進行結果分析。結果 NSE、CYFRA21?1肺癌雙顯色ELISA診斷試劑盒4℃放置時有效期為6箇月。試劑盒靈敏度為83?8％（129／154），特異度為53?8％（57／106），準確性為71?5％（186／260），受試者工作特徵麯線（ ROC）麯線下麵積Az 為0?90，各項指標均較單獨的NSE、CYFRA21?1明顯提高。結論成功製備雙顯色ELISA肺癌診斷試劑盒，該試劑盒可提高肺癌檢查的準確性、靈敏度，降低假暘性率，具有開髮為新型肺癌診斷試劑盒的條件。
목적：이용특이성여령민성교고적신경원특이희순화매（ NSE）、세포각단백21?1편단（ CYFRA21?1）폐암상관표지물，연제폐암쌍현색적체외연합진단매련면역반응（ ELISA）시제합。방법장NSE、CYFRA21?1량충항체안일정비례조합포피도매표판적판저제성시제합。분별이NSE、CYFRA21?1항원위연구대상，대포피액、포피시간、포피온도인소진행고찰，이시제합적은정성、령민도、준학성위지표진행결과분석。결과 NSE、CYFRA21?1폐암쌍현색ELISA진단시제합4℃방치시유효기위6개월。시제합령민도위83?8％（129／154），특이도위53?8％（57／106），준학성위71?5％（186／260），수시자공작특정곡선（ ROC）곡선하면적Az 위0?90，각항지표균교단독적NSE、CYFRA21?1명현제고。결론성공제비쌍현색ELISA폐암진단시제합，해시제합가제고폐암검사적준학성、령민도，강저가양성솔，구유개발위신형폐암진단시제합적조건。
Objective To develop and verify a diagnostic enzyme?linked immunosozbent assay( ELISA) kit in vitro for lung cancer by using lung cancer?related markers of neuron?specific enolase(NSE) and cytokeratin 19 fragment(CYFRA21?1) with high specificity and sensitivity. Methods In vitro diagnostic ELISA kits were prepared by coating anti?NSE and anti?CYFRA21?1 antibodies at the bottom of the microtiter plates at a proper proportion. NSE and CYFRA21?1 antigens were used as research subjects. Coating buff?er, packet time and packet temperature were investigated by detecting the index of stability, sensitivity and accuracy of ELISA kits. Re?sults Period of validity of in vitro NSE and CYFRA21?1?based dual?color diagnostic ELISA kit for lung cancer was 6 months at 4℃. The sensitivity,specificity and accuracy of in vitro NSE and CYFRA21?1?based, dual?color diagnostic ELISA kit were 83?8%( 129/154),53?8%(57/106) and 71?5%(186/260),which were higher than that of anti?NSE or anti?CYFRA21?1 antibodies diagnostic ELISA kits. And the areas under the receiver operating characteristics curves was 0?90. Conclusion NSE and CYFRA21?1?based lung cancer dual?color diagnostic ELISA kit was successfully prepared, which could improve the sensitivity,specificity and accuracy of de?tecting lung cancer. And it was confirmed that it has the potential of developing into a new diagnostic molecular imaging reagent for lung cancer.
