罗氏电化学发光检测系统促甲状腺激素受体抗体检测方法学评价及性能验证

Evaluation of the Methodology for Thyrotropin Receptor Antibody Measurement with Roche Electro Chemiluminescence System

目的 按CAP和15189实验室认可的要求,对罗氏电化学发光系统促甲状腺激素受体抗体（TRAb）检测方法进行评价和性能验证。方法 取高、低浓度混合血清,分别进行批内20次和连续20天检测,统计分析批内不精密度和批间不精密度;将高浓度和低浓度血清按一定比例混合进行检测,验证分析测量范围;取接近厂商提供最低检测限值的标本连续检测12天,进行检测限（LoQ）验证;取随机正常体检人群的血清20份,进行参考区间验证;测50份正常人血清和50份病例组血清进行特异性和灵敏度的验证;选取各浓度血清14份,进行室间比对。结果 高、低浓度批内不精密度为CV 0.63%和CV6.13%;批间不精密度为CV 4.15%和CV 9.55%;LoQ为1.20IU/L;AMR为2.72~33.66IU/L;参考区间〈1.24IU/L;特异性为94%,敏感度为92%;室间比对偏差小于1/2CLIA＇88规定的允许误差,符合室间比对质量要求。结论 本系统性能符合实验室要求。

Objective To evaluate the method for thyrotropin receptor antibody（TRAb） measurement with Roche Electro chemiluminescence （ECL） system and to establish the reference range in our laboratory. Methods The within-run and between-day imprecision was performed with high and low lever mixed serum. The analytic measure range （AMR） was evaluated with serially diluted serums. Limit of quantity （LoQ） was evaluated with continuous detection of low level serums. 20 normal sera were random taken to verify the reference range. 50 normal human serum and 50 patient＇ s serum samples were used to verify the specificity and sensitivity of method. Results The imprecision of within-run for high and low concentration of TRAb sample were 0.63% and 6. 13%. The imprecision of between-day for high and low value concentration of TRAb sample were 4.15% and 9.55%. Reportable low limit was 1.20IU/L. The analytical measurement range （AMR） was 2.72-33.66 IU/L. the reference range was less than 1.24 IU/L. The specificity and sensitivity of measurement were 94% and 92% respectively. The bias of two detection system measurement data was less than the acceptable biases of the laboratory. Conclusion The Electro chemiluminescence system for the TRAb measurement meets the requirement of CAP.