免疫散射比浊法检测血清淀粉样蛋白A的性能验证及评价  

Performance validation and evaluation of immune scattering turbidimetric method for detecting serum amyloid A

作　　者：赵晓君 朱宇清 陈子齐 陆银华 ZHAO Xiaojun;ZHU Yuqing;CHEN Ziqi;LU Yinhua(Department of Clinical Immunology,Shanghai Center for Clinical Laboratory,Shanghai 200126,China)

机构地区：[1]上海市临床检验中心临床生化免疫学研究室,上海200126

出　　处：《国际检验医学杂志》2023年第S01期78-82,共5页International Journal of Laboratory Medicine

摘　　要：目的对免疫散射比浊法检测血清淀粉样蛋白A(SAA)的性能进行验证及评价。方法参考美国临床和实验室标准协会(CLSI)相关文件(EP15-A2、EP6-A、C28-A3)对免疫散射比浊法检测SAA的性能(精密度、正确度、线性范围和生物参考区间)进行验证。结果精密度验证:应用Aristo系统进行检测,SAA低值和高值质控品批内精密度变异系数(CV)分别为3.35%、1.91%,批间CV分别为2.54%、3.52%,应用Astep PLUS系统进行检测,低值和高值质控品批内CV分别为2.23%、2.12%,批间CV分别为3.10%、4.09%,结果的变异系数均在试剂厂家声明的范围内;正确度验证:将Aristo系统SAA检测结果与西门子BN ProSpec系统SAA结果进行比对,两者之间差异无统计学意义,进行相关回归分析,相关系数r^(2)=0.992,预期相对偏倚11.79%;Astep PLUS系统与BN ProSpec系统比对结果差异无统计学意义(r^(2)=0.997),预期相对偏倚为5.5%。用两种系统分别对相同来源的血清样本和全血样本SAA进行检测,检测结果均无统计学差异(r^(2)≥0.95),预期相对偏倚分别为7.51%、2.06%。线性范围验证:用Aristo系统检测,血清样本SAA线性范围为2.72~323.48 mg/L(r^(2)≥0.99);用Astep PLUS系统检测,线性范围为2.88~314.00 mg/L(r^(2)≥0.99),均包含厂家声明的范围,线性验证通过;生物参考区间验证:两种系统SAA检测结果均只有1例超过参考区间,符合≤2例超出参考区间的规定。结论免疫散射比浊法检测SAA的性能良好,可用于临床常规检测。Objective To validate and evaluate the performance of immune scattering turbidimetric method for detecting serum amyloid A.Methods Referring to the relevant documents of the American Clinical and Laboratory Standards Institute(CLSI EP15-A2,EP6-A,C28-A3)the performance of immune scattering turbidimetric method for detecting serum amyloid A was validated,including precision,accuracy,linear range,and biological reference range.Results Precision verification:The Aristo system was used for testing,and the intra batch precision variation coefficients(CV)of SAA low and high value quality control samples were 3.35%and 1.91%,respectively.The inter batch CV was 2.54%and 3.52%,respectively.The Astep PLUS system was used for testing,and the intra batch CV of low and high value quality control samples were 2.23%and 2.12%,respectively.The inter batch CV was 3.10%and 4.09%,respectively.The coefficient of variation of the results was within the range declared by the reagent manufacturer;Accuracy verification:Compare the Aristo system SAA detection results with the Siemens BN ProSpec system SAA results,and there is no statistical difference between the two.Conduct correlation regression analysis,with a correlation coefficient of r^(2)=0.992 and an expected relative bias of 11.79%;The comparison results between the Astep PLUS system and the BN ProSpec system showed no statistical difference(r^(2)=0.997),with an expected relative bias of 5.5%.Two systems were used to detect SAA in serum samples and whole blood samples from the same source,and the detection results showed no statistical difference(r^(2)≥0.95).The expected relative bias was 7.51%and 2.06%,respectively.Linear range validation:Detected using the Aristo system,the linear range of serum sample SAA is 2.72-323.48 mg/L(r^(2)≥0.99);Tested using the Astep PLUS system,the linear range is 2.88-314 mg/L(r^(2)≥0.99),which includes the range declared by the manufacturer.The linearity verification is passed;Biological reference interval validation:Only one case of SAA detect

关 键 词：血清淀粉样蛋白A 免疫散射比浊法 性能验证 

分 类 号：R446[医药卫生—诊断学]