ARCHETECT高敏肌钙蛋白Ⅰ试剂盒性能评价  

Performance Evaluation of ARCHETECT High-sensitivity Cardiac TroponinⅠKit

作　　者：习浩[1] 刘荣静[1] XI Hao;LIU Rong-jing(Department of Clinical Laboratory,the Second Affiliated Hospital,Guangzhou MedicalUniversity,Guangzhou 510260,Guangdong,China)

机构地区：[1]广州医科大学附属第二医院检验科

出　　处：《医学信息》2019年第17期164-166,共3页Journal of Medical Information

摘　　要：目的评价ARCHETECT高敏肌钙蛋白Ⅰ(hs-cTnⅠ)试剂盒性能,以验证其是否符合临床实验室使用要求。方法参考CLSI的EP15-A2文件和相关文献对ARCHETECT高敏肌钙蛋白Ⅰ试剂盒精密度、正确度进行评价,EP17-A文件和相关文献对空白检测限(LoB)进行评价,EP6-A文件和相关文献对线性范围进行评价,参考NCCLSC28-A2文件,对健康体检者血浆标本分男女验证生物参考区间。结果实验测得hs-cTnⅠ高值样本(5.702μg/L)的批内不精密度CV为1.56%,总不精密度CV为1.27%,低值样本(0.003μg/L)的批内不精密度CV和总的不精密度CV均为0;hs-cTnI的回收率为97.50%;LoB为0.001μg/L;在检测范围内,hs-cTnI理论值与测定值的线性方程为Y=1.0006X-0.13136,R^2=0.9999;生物参考区间验证结果显示男性100.00%的结果在厂家提供的生物参考区间范围内,女性96.67%的结果在厂家提供的生物参考区间范围内。结论ARCHETECT高敏肌钙蛋白Ⅰ试剂盒性能通过验证,可为临床提供准确、可靠的hs-cTnⅠ定量检测结果,为临床对心肌损伤的诊断、治疗提供重要信息。Objective To evaluate the performance of the ARCHETECT high-sensitivity cardiac troponin I(hs-cTnI)kit to verify compliance with clinical laboratory requirements.Methods The accuracy of the ARCHETECT high-sensitivity troponin I kit were evaluated with reference to the CLSI EP15-A2 document and related literature.The blank detection limit(LoB)was evaluated in EP17-A and related literature,EP6-A and The relevant literature evaluates the linear range.Referring to the NCCLS C28-A2 document,the plasma samples of healthy subjects are compared with the male and female validated biological reference intervals.Results The intra-assay imprecision CV of the hs-cTnI high value sample(5.702μg/L)was 1.56%,the total imprecision CV was 1.27%,and the intra-assay imprecision of the low-value sample(0.003μg/L).The CV and the total imprecision CV were both 0;the recovery of hs-cTnI was 97.50%;the LoB was 0.001μg/L;in the detection range,the linear equation of the theoretical and measured values of hs-cTnI was Y=1.0006X-0.13136,R^2=0.9999;the bioreference interval verification results showed that 100.00%of the results were within the bio-reference interval provided by the manufacturer,and 96.67%of the results were within the bio-reference range provided by the manufacturer.Conclusion The performance of ARCHETECT high-sensitivity troponin I kit can provide accurate and reliable quantitative detection results of hs-cTnI for clinical diagnosis,and provide important information for clinical diagnosis and treatment of myocardial injury.

关 键 词：高敏肌钙蛋白Ⅰ 性能 精密度 正确度 生物参考区间 

分 类 号：R446.6[医药卫生—诊断学] R541.4[医药卫生—临床医学]