胶乳增强免疫比浊法检测血清25-羟维生素D的性能验证  

Determination of Serum 25-Hydroxyvitamin D by Latex-enhanced Immune Turbidimetry

作　　者：刘琴 王玲萍 陆仁伟 陆茜莹 许中[2] LIU Qin;WANG Ling-ping;LU Ren-wei;LU Xi-ying;XU Zhong(Clinical Laboratory,Caohu People's Hospital,Suzhou,Jiangsu,215144,China;Clinical Laboratory,East District of Suzhou Municipal Hospital,Suzhou,Jiangsu,215001,China)

机构地区：[1]苏州市相城区漕湖人民医院检验科,江苏苏州215144 [2]苏州市立医院东区检验科,江苏苏州215001

出　　处：《中国血液流变学杂志》2020年第3期369-372,共4页Chinese Journal of Hemorheology

摘　　要：目的 验证一种新上市的总25-羟维生素D[25(OH)D]检测试剂的方法 学性能.方法 性能验证使用苏州博源公司生产的总25-羟维生素D检测试剂,验证该试剂的正确度、精密度、线性、最大稀释倍数、分析灵敏度,方法 学验证采用罗氏诊断的试剂作为参比试剂,对临床样品进行评价.结果 总25-羟维生素D不同浓度水平血清样品:低值(19.36 ng/mL)、中值(54.51 ng/mL)、高值(97.80 ng/mL)的加标回收率分别为106.2%、102.3%、99.8%;低值、高值血清样品的批内精密度和总精密度分别为2.87%、1.42%和3.60%、2.09%,小于厂商声明的1/4TEa(6.25%)和1/3TEa(8.33%);线性范围为8.0~152.0 ng/mL;分析灵敏度符合厂商声明标准(2.9 ng/mL).方法 学比对收集健康体检者及患者血清样品(n=110),分别使用苏州博源(试验方法 ,Y)与罗氏诊断(参比方法 ,X)的总25-羟维生素D试剂进行检测,Deming回归方程为Y=-2.5853+1.0410X,相关系数r=0.951,Bland-Altman图中95.5%(105/110)的点落在95%一致性界限内.结论 苏州博源总25-羟维生素D的正确度、精密度、线性范围、最大稀释倍数、分析灵敏度和参考区间满足性能验证要求,样品比对结果 与罗氏诊断试剂具有一致性,可满足临床应用要求.Objective To verify the methodological performance of a newly marketed total 25-hydroxyvitamin D[25(OH)D]detection reagent.Methods A total 25-hydroxyvitamin D test reagent produced by Suzhou Boyuan Company,verifying the correctness,precision,linearity,maximum dilution multiple,analytical sensitivity of the reagent,methodological validation using Roche diagnostic reagent as reference reagent,clinical samples were evaluated.Results Standard-added recovery of serum samples with different concentrations of 25-hydroxyvitamin D:low value(19.36 ng/mL),median value(54.51 ng/mL),high value(97.80 ng/mL)were 106.2%,102.3%,99.8%,respectively;the in-batch precision and total precision of low and high value serum samples were 2.87%,1.42%and 3.60%,2.09%,less than 1/4 Tea(6.25%)and 1/3 Tea(8.33%);the linear range was 8.0-152.0 ng/mL;analytical sensitivity meets manufacturer's declaration standard(2.9 ng/mL).Methodological comparison of serum samples collected from health checkers and patients(n=110),using Suzhou Boyuan(test method,Y)and Roche Diagnostics(reference method,X)total 25-hydroxyvitamin D reagent,Deming regression equation is Y=-2.5853+1.0410X,correlation coefficient r=0.951,bland-altman 95.5%(105/110)of the points in the figure falls within the 95%limit.Conclusion The accuracy,precision,linear range,maximum dilution multiple,analytical sensitivity and reference interval of total 25-hydroxyvitamin D in Suzhou Boyuan meet the requirements of performance verification.The results of sample comparison are consistent with Roche Diagnostic reagent and can meet the requirements of clinical application。

关 键 词：总25-羟维生素D 血清 胶乳增强免疫比浊法 

分 类 号：R541.6[医药卫生—心血管疾病]