IMMULITE化学发光TSI检测分析性能验证及临床性能评估

An Analytical Verification and Clinical Performance Evaluation for IMMULITE Chemiluminescence TSI Detection

目的探讨IMMULITE 2000XPi全自动化学发光免疫分析TSI检测方法的精密度、正确度、线性范围等分析性能,及与Roche Cobas e602电化学发光Anti-TSHR检测方法间的临床性能差异。方法参考美国临床与实验室标准化协会(CLSI)有关文件,分别采用EP-15A3方案验证TSI精密度与正确度,采用EP6-A2方案验证TSI线性区间,并利用EP-17A2方案对TSI和Anti-TSHR进行方法学评估,比较二者临床性能在Graves病中诊断价值的差异。结果IMMULITE 2000XPi TSI正常及异常2个水平的重复性精密度分别为:3.38%、3.14%;中间精密度分别为:3.70%、6.62%;正确度验证区间涵盖验证物质的靶值;线性区间数据分析,二次及三次曲线非线性系数b2和b3均无显著性,数据呈线性。358例临床样本TSI与Anti-TSHR结果比较,灵敏度:89.0%vs 49.0%,配对灵敏度差异:40%(CI:31.9%~47.2%);特异性:94.7%vs 54.7%,配对特异性差异:40%(CI:28.2%~50.5%)。结论IMMULITE 2000XPi全自动发光TSI检测本实验室分析性能均能符合厂家声明,与Roche Cobas e602 Anti-TSHR比较,TSI检测方法在Graves病的辅助诊断中显示出更优的临床性能。

Objective To verify the analytical results of performance with precision,accuracy,and linear range of IMMULITE2000XPi automatic chemiluminescence immunoassay(CLIA)for TSI detection,so to further evaluate the clinical performance difference between the Roche Cobas e602 electrochemiluminescence immunoassay for Anti-TSHR detection.Methods According to the relevant documents of the American Society for Clinical and Laboratory Standardization(CLSI),the precision,accuracy and linear interval of immulite TSI detection were verified by using the EP-15A3 or EP6-A2 scheme,respectively.Furthermore,the difference of clinical performance for TSI detection in the Graves’disease diagnosis between Immulite TSI and Roche Anti-TSHR was accessed according to the EP-17A2.Results The repeatability precision of Immulite TSI at normal and abnormal concentration levels were 3.38%and 3.14%,respectively,while the intermediate precisions were 3.70%and 6.62%,respectively.The accuracy verification interval covered the target value of the verification substance.Linear interval data analysis indicated that the nonlinear coefficients b2 and b3 of the quadratic and cubic curves were not significant,hence the data patterns were linear.Comparing with Anti-TSHR,TSI showed results as following:sensitivity:89.0%vs 49.0%,paired sensitivity difference:40%(CI:31.9%,47.2%);TSI specificity:94.7%vs 54.7%,paired specificity difference:40%(CI:28.2%,50.5%).Conclusion The analytical performance of immulite 2000XPi TSI detection can meet the manufacturer's statement.Compared with Roche Cobas e602 Anti-TSHR,the TSI detection assay shows a better clinical performance in the auxiliary diagnosis of Graves’disease.