CAJ | 학술논문

目的建立可同时测定血清甲胎蛋白(AFP)和AFP免疫复合物(AFP-IgM)的快速、灵敏检测方法,探讨其在原发性肝细胞癌(HCC)诊断中的临床价值.方法利用时间分辨免疫荧光分析(TRFIA)技术,分别用Sm3+标记鼠抗人IgM单克隆抗体(M94181),Eu3+标记鼠抗人AFP单克隆抗体(M19301),建立双标记TRFIA(dual-TRFIA).选择HCC患者118例和肝良性病变(BLD)患者123例(肝硬化60例,慢性肝炎63例),健康体格检查者286例.分别用该法检测血清AFP和AFP-IgM水平,并用受试者工作特征(ROC)曲线进行临床诊断特性分析.采用SASS 6.12软件进行统计学处理.结果 dual-TRFIA法检测AFP和AFP-IgM的灵敏度分别为0.41 ug/L,10.00 U/L,与试剂盒[电化学发光免疫(ECLIA)AFP test和Hepa AFP-IC kit]相关性好(r=0.9987和0.9854,P均<0.05).AFP和AFP-IgM在HCC中的诊断灵敏度分别为46.61%(55/118),63.56%(75/118),诊断准确性分别为77.10%和77.40%.AFP和AFP-IgM联合检测可将灵敏度提高至72.88%(86/118,x2= 9.45,P=0.02),诊断准确性提高至84.10%(x2=6.24,P=0.04).结论 AFP-IgM是HCC新型血清标志物,同时检测AFP和AFP-IgM能明显提高对HCC的诊断灵敏度和准确性,有利于肝癌的早期诊断.dual-TR-IMFA法同时检测AFP和AFP-IgM稳定可靠,可以满足临床使用需要.
목적 건립가동시측정혈청갑태단백(AFP)화AFP면역복합물(AFP-IgM)적쾌속、령민검측방법,탐토기재원발성간세포암(HCC)진단중적림상개치.방법 이용시간분변면역형광분석(TRFIA)기술,분별용Sm3+표기서항인IgM단극륭항체(M94181),Eu3+표기서항인AFP단극륭항체(M19301),건립쌍표기TRFIA(dual-TRFIA).선택HCC환자118례화간량성병변(BLD)환자123례(간경화60례,만성간염63례),건강체격검사자286례.분별용해법검측혈청AFP화AFP-IgM수평,병용수시자공작특정(ROC)곡선진행림상진단특성분석.채용SASS 6.12연건진행통계학처리.결과 dual-TRFIA법검측AFP화AFP-IgM적령민도분별위0.41 ug/L,10.00 U/L,여시제합[전화학발광면역(ECLIA)AFP test화Hepa AFP-IC kit]상관성호(r=0.9987화0.9854,P균<0.05).AFP화AFP-IgM재HCC중적진단령민도분별위46.61%(55/118),63.56%(75/118),진단준학성분별위77.10%화77.40%.AFP화AFP-IgM연합검측가장령민도제고지72.88%(86/118,x2= 9.45,P=0.02),진단준학성제고지84.10%(x2=6.24,P=0.04).결론 AFP-IgM시HCC신형혈청표지물,동시검측AFP화AFP-IgM능명현제고대HCC적진단령민도화준학성,유리우간암적조기진단.dual-TR-IMFA법동시검측AFP화AFP-IgM은정가고,가이만족림상사용수요.
Objective Serum alpha-fetoprotein (AFP) is a widely used marker of hepatocellular carcinoma (HCC), although its diagnostic efficacy remains to be improved. Elevated levels of immunocomplex form of AFP-IgM in HCC patients have been reported. In this study a novel dual-labeled time-resolved immunofluorometric assay (dual-TRFIA) was developed to measure serum AFP and AFP-IgM levels simultaneously in order to establish a more effective serum maker detection method for HCC. Methods The dual-TRFIA for AFP-IgM or AFP was established by using Sm3+-labeled anti-human IgM monoclonal antibody (McAb) and Eu3+-labeled anti-AFP McAb as tracer antibodies. Serum AFP-IgM/AFP concentrations were measured in 118 patients with HCC, 60 patients with cirrhosis, 63 patients with chronic hepatitis and 286 healthy controls with the dual-TRFIA. The diagnostic efficacy was evaluated using receiver operating characteristic (ROC) curve. SAS 6.12 was used to analyze the data. Results The lowest detective concentrations for AFP and AFP-IgM were 0.41 ug/L and 10.00 U/L, respectively. AFP concentrations determined with duaI-TRFIA correlated well with those tested with electrochemiluminescenec immunoassay (ECLIA) (r= 0.9987, P<0.05). The sensitivity for diagnosing HCC with serum AFP and AFP-IgM was 46.61% (55/ 118) and 63.56% (75/118), respectively. The area under the ROC curve for AFP and AFP-IgM was 77.10% and 77.40%, respectively. However, the diagnostic sensitivity increased to 72.88% (86/118) (x2=9.45, P=0.02) and accuracy increased to 84.10% (x2=6.24, P=0.04) when the two markers were combined. Conclusions A highly sensitive and reliable dual-TRFIA for determination of serum AFP-IgM and AFP by a single test has been developed. It is suggested that combined measurement of serum AFP-IgM and AFP levels may improve the detection sensitivity of HCC.