化学发光免疫技术检测鳞状细胞癌抗原的性能验证

Chemiluminescence immunoassay in detection of squamous cell carcinoma antigen:performance validation and evaluation

目的:验证和评价雅培i2000SR全自动化学发光仪定量检测鳞状细胞癌抗原(SCC Ag)的分析性能。方法:对雅培i2000定量检测SCC Ag的精密度、线性进行验证。用i2000和酶联免疫吸附技术(ELISA)方法检测相同标本SCC Ag,对检测结果进行比较分析。结果:精密度均符合雅培性能标准;SCCAg检测呈一次线性(r=0.999,P<0.05),线性范围为:0.24-61.9 ng/mL;两种方法检测相同标本,i2000的阳性率为60%,ELISA的阳性率为35%。以i2000为标准,ELISA的相对敏感度为54.2%、相对特异性为93.8%,两种方法的总符合率为70%。结论:雅培i2000检测SCC Ag的主要分析性能验证结果与厂商声明的基本一致,与旧方法ELISA的总符合率良好,符合质量目标要求,可应用于临床标本检测。

Objective： To evaluate the analytical performance of i2000SR automatic chemiluminescence analyzer in quantitative detection of squamous cell carcinoma antigen （SCC-Ag）. Methods ： We validated the precision and linearity performance of i2000SR （Abbott） analyzer in quantitative measurement of SCC-Ag. The same specimens were tested by both i2000 and ELISA, and then the results were compared and analyzed. Results ： The precisions were in line with the Abbott performance standards. SCC-Ag showed good linearity （ r = 0. 999, P 〈0.05 ） with a range between 0.24 and 61.9 ng/mL. In the detection of same specimens, the positive rate for i2000 was 60% vs 35% for ELISA. Using i2000 test as the reference, the relative sensitivity and specificity of ELISA was 54.2% and 93.8%, respectively. The total coincidence rate of the two methods was 70%. Conclusion：Performance validation of i2000SR analyzer in detection of SCC-Ag basically correlates with as claimed by the manufacturer and is well consistent with conventionally used ELISA. Therefore, i2000SR meets quality standards and can be applied for clinical purposes.