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。
作者
刘琴
王玲萍
陆仁伟
陆茜莹
许中
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)
出处
《中国血液流变学杂志》
CAS
2020年第3期369-372,共4页
Chinese Journal of Hemorheology
作者简介
刘琴(1975-),女,江苏苏州人,学士,副主任技师,主要从事临床生化检验及实验室管理;通讯作者:许中,eastone@126.com
