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目的对基于流式荧光技术联合检测血清AFP/CEA进行性能评价。方法通过流式荧光技术联合检测临床血清样本的AFP/CEA,评价该方法的灵敏度、精密度、准确度,并分析了AFP、CEA 2个指标在肝癌组与对照组中的差异。结果基于流式荧光技术的AFP、CEA最低检测限分别为0.57 ng/ml、0.23 ng/ml。AFP批内变异系数(CV)为2.26%~3.38%,室内CV为7.30%~10.95%。CEA批内CV为2.30%~5.26%,室内CV为7.76%~13.95%。与电化学发光法进行方法学比对AFP相关系数(r)=0.993 6,CEA相关系数(r)=0.993 7。肝癌组中AFP浓度为(253.24±316.47)ng/ml,CEA浓度为(14.07±53.70)ng/ml;对照组中AFP浓度为(3.28+1.82)ng/ml,CEA浓度为(2.74±1.60)ng/ml。肝癌组AFP/CEA浓度值显著高于对照组。结论通过流式荧光技术可以实现AFP、CEA并行检测,方法学性能良好,可应用于临床检验。
Objective To evaluate the performance of the combined detection of serum AFP / CEA using flow cytometry. Methods AFP / CEA was detected by flow cytometry in clinical serum samples. The sensitivity, precision and accuracy of the method were evaluated. The differences of AFP and CEA between the two groups were also analyzed. Results The minimum detection limits of AFP and CEA based on the flow cytometry were 0.57 ng / ml and 0.23 ng / ml, respectively. The coefficient of variation (CV) of AFP was 2.26% -3.8%, and the indoor CV was 7.30% -10.95%. The CV of CEA batch was 2.30% -5.26%, and the indoor CV was 7.76% ~ 13.95%. Compared with electrochemiluminescence method, the correlation coefficient of AFP (r) = 0.993 6, CEA correlation coefficient (r) = 0.993 7. The AFP concentration in the liver cancer group was (253.24 ± 316.47) ng / ml and the CEA concentration was (14.07 ± 53.70) ng / ml in the control group. The AFP concentration in the control group was (3.28 ± 1.82) ng / ng / ml. Liver cancer group AFP / CEA concentration was significantly higher than the control group. Conclusions AFP and CEA can be detected in parallel by flow cytometry. The method has good performance and can be applied to clinical tests.