目的 建立及评价高敏感方法检测心肌肌钙蛋白Ⅰ(cTnI)在化学发光免疫分析仪的空白限(LoB)、检出限(LoD)和定量检测限(LoQ).方法 参照美国临床实验室标准化协会(CLSI) EP17-A文件和相关文献,将cTnI空白样本和系列低浓度样本在BECKMAN-COULTER DXI800化学发光免疫分析仪(简称DXI800)上进行检测,依据数据的分布规律,采用相应的统计学方法确定血清cTnI的LoB、LoD和LoQ,同时用传统方法建立cTnI的检测低限(LLD)、生物检测限(BLD)和功能灵敏度(FS).结果 依据CLSI EP17-A方案建立cTnI的LoB为3.5 ng/L、LoD为11.5 ng/L、LoQ为30 ng/L;应用常规方法建立的LLD为5.4 ng/L、BLD为10～ 20 ng/L、FS为30 ng/L.结论 应用2种方法建立的LoB和LLD均低于仪器说明书声明的灵敏度性能,DXI800检测cTnI的分析灵敏度得到验证,同时建立了本实验室cTnI检测的LoB 、LoD、LoQ和FS,为临床提供准确、可靠的检验结果.%Objective To establish and evaluate the limil of blank ( LoB) ,the limit of detection ( LoD) and the limit of quantitation ( LoQ) of high-sensitivity assays for cardiac troponin I ( cTnI) on chemiluminescence immune analyzer. Methods According to the document EP17-A published by Clinical and Laboratory Standards Institute (CLSI), cTnI blank samples and serial low concentration samples were detected by BECKMAN-COULTER DXI800 chemiluminescence immune analyzer ( DX1800). Based on the data distribution, by relevant statistical methods, the LoB, LoD and LoQ of cTnI were calculated. Simultaneously, by the traditional methods, the low limit of detection (LLD), biological limit of detection (BLD) and function sensitivity (FS) were established. Results According to CLSI EP17-A document, the LoB was 3.5ng/L, the LoD was 11. 5ng/L, and the LoQ was 30 ng/L. The LLD was 5.4 ng/L, the BLD was 10-20 ng/L,and the FS was 30 ng/L by the traditional methods. Conclusions The LoB and LLD are both lower than the sensitivity performance of the manufacturer declaration. The analysis sensitivity of cTnI by DXI800 is validated. The established LoB, LoD, LoQ and FS of cTnI in the laboratory provide more accurate and reliable results.
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