Biolis 30i生化分析仪检测血清25-羟维生素D的初步评价

Preliminary Evaluation of Serum 25-Hydroxyvitamin D Detected by Biolis 30i Biochemical Analyzer

目的对一款新上市的台式生化分析仪检测总25-羟维生素D[25(OH)D]的分析性能进行验证。方法Biolis 30i全自动生化分析仪配套苏州博源公司生产的25(OH)D检测试剂,验证正确度、精密度、线性、可报告范围、血红蛋白干扰试验等主要性能;收集30份健康体检者及患者血清样品使用Biolis 30i生化分析仪(Y)与罗氏发光(X)进行比对评价。结果25(OH)D低、中、高值3种水平血清样品的回收率分别为97.8%、102.3%、102.4%;低值、高值血清样品的批内精密度和总精密度分别为3.76%、2.72%和4.54%、3.26%,均在厂商声明的各自允许范围内;线性范围为8.0~152 ng/mL,可报告范围为725 ng/mL;血红蛋白干扰实验,在血红蛋白浓度≤4.52 g/L时,对标本结果无明显影响。方法学比对,回归方程为Y=0.8969X-1.6121,R^(2)=0.9527,两者一致性良好。结论Biolis 30i全自动生化分析仪配套苏州博源总25(OH)D检测试剂的正确度、精密度、线性范围等满足性能验证要求,样品比对结果一致性良好,可临床应用。

Objective To verify the analytical performance of a newly available desktop biochemical analyzer for total 25-hydroxyvitamin D(25(OH)D).Methods Biolis 30i automatic biochemical analyzer was equipped with 25(OH)D detection reagent produced by Suzhou Boyuan Company to verify the main performance such as accuracy,precision,linearity,reportable range and hemoglobin interference test.30 serum samples of health examiners and patients were collected for comparison evaluation using Biolis 30i biochemical analyzer(Y)and Roche luminescence(X).Results The recovery rates of serum samples with low,medium and high 25(OH)D were 97.8%,102.3%and 102.4%.The batch and total precision of serum samples were 3.76%,2.72%,and 4.54%,3.26%,respectively,both were within the allowable range declared by the manufacturer.The linear range was 8.0-152 ng/mL and the reportable range was 725 ng/mL.In the hemoglobin interference experiment,when the hemoglobin concentration was≤4.52 g/L,there was no significant effect on the results of the specimen.In methodological alignment,the regression equation was Y=0.8969X-1.6121 and R^(2)=0.9527,showing good agreement.Conclusion The accuracy,precision and linear range of Suzhou Boyuan total 25(OH)D detection reagent supporting Biolis 30i automatic biochemical analyzer meet the requirements of performance verification.The sample comparison results are consistent and it can be used in clinical practice.