Xie Meijuan, Huang He, Hang Jianfeng, Dong Zhining, Xiao Dengyan, Xu Ping, Zhu Cuiying, Xu Weiwen
a Institute of Antibody Engineering, Biotechnology College, Southern Medical University , Guangzhou , China.
J Immunoassay Immunochem. 2015;36(3):265-83. doi: 10.1080/15321819.2014.937542.
We developed a TR-FIA kit for quantitative detection of CA50. This study aims to evaluate the analytical and clinical performances of this kit. Precision, accuracy, specificity, sensitivity, stability, and endogenous interference of this kit are evaluated. Reference range is established. Coincidence rate and correlation between TR-FIA and RIA are evaluated. ROC is adopted to evaluate the diagnostic performance. This kit shows excellent precision with a coefficients of variation (CVs) ranged from 2.2-9.3%, accuracy (average recovery, 98.5%), sensitivity (minimum detectable concentration is 0.2 U/mL), specificity (all cross-reactivity is less than 0.1% except CA199, which is 0.175%), and storage stability (recoveries, 90.8-100.4%). Bilirubin, hemoglobin, and triglyceride dose not interfere with CA50 detection (recovery, 97.13-109.1%). The range from 0-25 U/mL is chosen as the reference range. There are good correlation (r = 0.804) and coincidence (p = 0.608, kappa = 0.924) between TR-FIA and RIA. Diagnostic performance of this kits, which based on RIA results, is perfect (AUC = 0.996), and the diagnostic accuracy for malignancy diagnosis is in moderate degree (AUC, 0.802-0.861). The TR-FIA (CA50) kit performs well in analytical and clinical performances, and can be employed in the clinical diagnosis of malignancy.
我们研发了一种用于定量检测CA50的时间分辨荧光免疫分析（TR-FIA）试剂盒。本研究旨在评估该试剂盒的分析性能和临床性能。评估了该试剂盒的精密度、准确性、特异性、灵敏度、稳定性和内源性干扰。建立了参考范围。评估了TR-FIA与放射免疫分析（RIA）之间的符合率和相关性。采用ROC评估诊断性能。该试剂盒显示出优异的精密度，变异系数（CV）范围为2.2-9.3%，准确性（平均回收率98.5%），灵敏度（最低检测浓度为0.2 U/mL），特异性（除CA199交叉反应率为0.175%外，所有交叉反应率均小于0.1%），以及储存稳定性（回收率90.8-100.4%）。胆红素、血红蛋白和甘油三酯不干扰CA50检测（回收率97.13-109.1%）。选择0-25 U/mL作为参考范围。TR-FIA与RIA之间存在良好的相关性（r = 0.804）和符合率（p = 0.608，kappa = 0.924）。基于RIA结果，该试剂盒的诊断性能良好（AUC = 0.996），对恶性肿瘤诊断的准确性为中等程度（AUC，0.802-0.86）。TR-FIA（CA50）试剂盒在分析性能和临床性能方面表现良好，可用于恶性肿瘤的临床诊断。
