一款国产高敏肌钙蛋白T化学发光试剂的性能评估  

The Evaluation of the Performance for a Domestic High Sensitivity Cardiac Troponin T Chemiluminescence Kit

作　　者：方宜臻 范春明 谢华斌 FANG Yizhen;FAN Chunming;XIE Huabin(Department of Clinical Laboratory,Xiamen Cardiovascular Hospital of Xiamen University,Xiamen 361006,China;Xiamen Key Laboratory of Precision Medicine for Cardiovascular Disease,Xiamen 361006,China)

机构地区：[1]厦门大学附属心血管病医院检验科,福建厦门361006 [2]厦门市心血管疾病精准医学重点实验室,福建厦门361006

出　　处：《标记免疫分析与临床》2023年第9期1584-1590,共7页Labeled Immunoassays and Clinical Medicine

基　　金：厦门市医疗卫生指导性项目(编号:3502Z20209140,3502Z20209141)。

摘　　要：目的 对一款国产高敏肌钙蛋白T化学发光试剂进行性能评估。方法 参照临床实验室标准化委员会EP17-A2、EP15-A3、EP6-A、EP7-A2方案进行灵敏度、精密度、线性范围、可报告范围和抗干扰能力验证,并与罗氏电化学发光试剂进行相关性分析。同时,对全血样本与血浆样本检测结果进行比对分析。结果 该试剂空白限、检出限和定量限分别为1.23ng/L、1.3ng/L和3.52ng/L;批内不精密度与总不精密度均<5%;线性范围和可报告范围分别为:2.79~11 357.05ng/L、2.85~113 570.5ng/L;多种干扰物对该试剂均无显著干扰。该试剂不仅与罗氏试剂的检测结果具有显著相关性(r=0.998),而且其全血样本与血浆样本的检测结果具有良好的相关性(r=0.990)。结论 该国产试剂多项性能优于罗氏电化学发光试剂并且可用于全血检测,极具临床推广价值。Objective To operate a performance evaluation for a domestic high sensitivity cardiac troponin T chemiluminescence reagent.Methods We tested relative properties of a domestic reagent,including sensitivity,precision,linear range,reportable range and anti-jamming capability,according to the Clinical and Laboratory Standards Institute(CLSI)guidelines(EP17-A2,EP15-A3,EP6-A,EP7-A2),and also conducted the correlation analysis with the Roche electrochemical luminescence reagent.In addition,the comparative analysis of the result of whole blood samples and plasma samples was performed.Results The limit of blank,limit of detection and limit of quantification were 1.23ng/L,1.3ng/L and 3.52ng/L,respectively.The intra-batch imprecision and the total imprecision were less than 5%.The linear range was 2.79ng/L-11357.05ng/L and the reportable range was 2.85 ng/L-113570.5 ng/L.The reagents were not significantly affected by a variety of distractors.The results of the domestic reagent showed a significant correlation with the results of ROCH electrochemical chemiluminescence kit(r=0.998).In addition,a good correlation was observed between the result of plasma samples and the result of whole blood samples which were detected by the domestic reagent(r=0.990).Conclusion The studied domestic reagent is superior to Roche electrochemical luminescence reagent in multiple aspects and could be used for the whole blood sample detection,which is worth of applying widely in clinical practice.

关 键 词：性能评估 高敏肌钙蛋白T 国产试剂 

分 类 号：R392-33[医药卫生—免疫学]