机构地区:[1]广州中医药大学第四临床医学院/深圳市中医院医学检验科,广东深圳518033
出 处:《医学检验与临床》2022年第3期41-47,共7页Medical Laboratory Science and Clinics
摘 要:目的:为确保检验质量,对贝克曼库尔特UnicelDxI800免疫检测系统促甲状腺激素新一代试剂TSH3rd的测量精密度,准确度,线性,分析测量范围等进行验证。方法:使用两个水平质控品和低值血清池样本进行精密度验证。利用国家卫生健康委员会临床检验中心室间质量评价,结合回收实验进行准确度验证。配制5个低值(预期值0.016,0.010,0.008,0.006,0.005,0.001 mIU/L)混合血清样本,每天2批次,连续检测10天,读取相对发光单位(Relative Luminescence Unit,RLU),计算变异系数(CV),评估功能灵敏度。依据美国临床和实验室标准化协会EP06-A批准指南,选择接近线性上下限浓度样本,参照S=7Specimens稀释方案,配制高浓度与低浓度血清池样本,按预定比例进行稀释得到系列样本,每个浓度水平重复测量2次,取平均值。利用Abacus2.0和SPSS22.0软件包进行多项式线性回归分析和分析测量范围验证。结果:中值质控品(QC2)批内不精密度:变异系数(CV)5.140%;实验室内不精密度:CV 7.700%。高值质控品(QC3)批内不精密度:CV 3.570%;实验室内不精密度:CV 4.410%。低值血清池样本批内不精密度:CV 5.059%;实验室内不精密度:CV 5.318%。准确度评估显示TSH3rd平均偏差为4.66%;平均回收率为102.268%。功能灵敏度为0.005 mIU/L。线性回归方程为Y=0.989 X-0.101,线性相关良好。TSH3rd的分析测量范围约0.005~47.000mIU/L。结论:TSH测量精密度,准确度,线性,分析测量范围等性能指标优于厂商声明,完全满足临床的要求。Objective:The purpose of this study is describes the verification of the measurements precision,accuracyjinearity and analytical measurements range(AMR)of next-generation thyroid-stimulating hormone(TSH3rd)assay for Beckman Coulter Unicel DxI800 immunoassay system Methods:Precision evaluation was performed using low-concentration sera pool specimens and two levels of commercial Quality Control(QQ) specimens.Accuracy was estimated utilizes a combination of External Quality Assessment(EQA)results from the Clinical Laboratory Center of National Health Commission of the People's Republic of China and recovery experiments.Five mixed serum samples with low values(expected value 0.016,0.010,0.008,0.006,0.005,0.001 mIU/L)were prepared,2 batches per day for 10 consecutive days,and the Relative Luminescence Unit(RLU)was read.Coefficients of variation(CV)were calculated to evaluate functional sensitivity.Reference to(Clinical and Laboratory Standards Institute,CLS1)EP06-A approval guidelines,specimens which concentrations close to the upper and lower limits of linearity was collected for study.Polynomial linear regression analysis was performed,and linearity regression analysis and AMR was verifed in accordance with S=7 specimens dilution scheme,Preparation ofhigh concentration specimen and low concentration specimen sera pools,at a predetermined ratio of low concentration and H(High)concentration,sera to obtain a series of specimens.Repeated measurements was done with each specimens.Results:Within-run imprecisions for median concentration Quality Control(QC2)material shows that Coefficient ofVariation(CV)was 5.140%;Within-Laboratory imprecision for QC2 shows that CV was 7.700%.Within-run imprecisions for high concentration Quality Control(QC3)material shows CV was 3.570%;Within-Laboratory imprecision for QC3 shows CV was 4.410%.Within-run imprecisions for low—concentration sera pool shows CV was 5.059%,and Within—Laboratory imprecision for low-concentration sera pool shows CV was 5318%.Accuracy evaluation of TSH shows
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