肌钙蛋白I检测试剂质量性能的一致性评价

目的:评价两厂家的荧光免疫层析法肌钙蛋白I(cTnI)检测试剂质量性能的一致性。方法:检测样本为企业参考品,采用Origin 2019软件对其质量控制的关键技术性能的一致性进行分析。结果:Kolmagorov-Smirnov检验分析显示,在0.05水平下,其最低检测限、重复性(25ng/mL)、批间差(25ng/mL)存在显著不同,其重复性(1ng/mL)、准确度、特异性、批间差(1ng/mL)不存在显著不同;函数拟合分析显示,其线性方程Spearman相关系数r=1,相关性高。结论:其最低检测限、重复性(25ng/mL)、批间差(25ng/mL)不一致;其重复性(1ng/mL)、准确度、特异性、批间差(1ng/mL)一致性良好,线性相关性良好;综合分析认为,其cTnI检测试剂的质量性能不一致。根据分析结果,提出以下建议:选择更合适的抗原抗体原材料、提高试剂生产工艺、应用新兴标记材料等新技术以提高不同厂家检测试剂的质量性能的一致性。

A Consistent Evaluation of the Quality Performances of Cardiac Troponin I Test Reagents

Objective:The consistency of the quality performances of fluorescent immunocography assay(FIA)testing reagents with regard to Cardiac troponin I(cTnI)in two manufacturers was evaluated.Methods:The test samples are internal reference.The Origin 2019 software is used to analyze the consistency of the key technical performances of their quality control.Results:Kolmagorov-Smirnov test analysis shows that at the level of 0.05,the performances with their detection of limit and reproducibility(25ng/mL)and batch-to-batch reproducibility(25ng/mL)are all significantly inconsistent,and that with their reproducibility(1ng/mL)and accuracy and specificity and batch-to-batch reproducibility(1ng/mL)are all consistent;and that with the function fitting analysis of the two linear equations shows the Spearman correlation coefficient r=1 and their correlation is at a high level.Conclusion:The two manufactures reagents’quality performances of limit and reproducibility(25ng/mL)and batch-to-batch reproducibility(25ng/mL)are inconsistent;and that of the reproducibility(1ng/mL)and accuracy and specificity and batch-to-batch reproducibility(1ng/mL)are consistent;and their linear correlation is good.These statistical analyses show that their quality performances of cTnI detection reagents are inconsistent.Our suggestion is on the basis of the analyses above.Choosing more suitable raw materials about antigens and antibodies in order to improve reagents'production technology,applying new technologies such as emerging labeling materials in order to improve the consistency of the quality performance of detection reagents among different manufacturers.