CAJ | 학술논문

目的对电化学发光法( ECLIA)检测游离前列腺抗原(fPSA)的性能进行评价.方法选取标本经化学发光微粒测定( CMIA)实验检测前列腺特异性抗原(tPSA)的标本341例,其中tPSA值异常标本97例,tPSA值正常标本244例.以CMIA为比对方法,对标本应用电化学发光法( ECLIA)测定fPSA及tPSA并计算f/tPSA比值,对结果进行统计学处理和分析.结果与比对方法( CMIA)结果相比,评价方法(ECLIA) fPSA测定的相关系数为0.99,f/t PSA比值测定的相关系数为0.96；f/t PSA比值的相对灵敏度为85.71％,相对特异性为92.6％,相对符合率为87.4％.与高胆红素、高脂、溶血、RF因子、CEA、AFP、CA125、CA153、CA199等不存在交叉反应.结论电化学发光法( ECLIA)检测性能基本满足临床常规检测的需要.
목적 대전화학발광법( ECLIA)검측유리전렬선항원(fPSA)적성능진행평개.방법 선취표본경화학발광미립측정( CMIA)실험검측전렬선특이성항원(tPSA)적표본341례,기중tPSA치이상표본97례,tPSA치정상표본244례.이CMIA위비대방법,대표본응용전화학발광법( ECLIA)측정fPSA급tPSA병계산f/tPSA비치,대결과진행통계학처리화분석.결과 여비대방법( CMIA)결과상비,평개방법(ECLIA) fPSA측정적상관계수위0.99,f/t PSA비치측정적상관계수위0.96；f/t PSA비치적상대령민도위85.71％,상대특이성위92.6％,상대부합솔위87.4％.여고담홍소、고지、용혈、RF인자、CEA、AFP、CA125、CA153、CA199등불존재교차반응.결론 전화학발광법( ECLIA)검측성능기본만족림상상규검측적수요.
Objective To analyze the clinical performance of free prostate-specific antigen (fPSA)detection by ECLIA method,and evaluate whether ECLIA is suitable for clinical use.Methods 341samples were collected and tested prostate-specific antibodies with CMIA and ECLIA methods.These samples contain:97 samples with abnormal high PSA value tested by CMIA method,and 244 normal PSA samples.Use CMIA as the reference method,and detect fPSA,tPSA levels,and the ratio of fPSA/tPSA.Analyze the testing results with statistical methods.Results Compared with CMIA,correlation coefficent of ECLIA fPSA detection is 0.99; correlation coefficent of f/tPSA ratio detection is 0.96; the sensitivity,specificity of ECLIA f/tPSA ratio detection are 85.71％,92.6％ respectively,the agreement rate with ECLIA is 87.4％.No cross reaction with bilirubin,lipohemia,hemolysis,RF,CEA,AFP,CA125,CA153,CA199 were found in the tests.Conclusion The ECLIA method for free prostate-specific antigen detection showed good clinical performance; and is suitable for clinical use.