一款国产NT-proBNP化学发光免疫试剂的性能评估

A Performance Evaluation of A Domestic NT-proBNPChemiluminescence Immune Kit

目的对一款国产NT-proBNP化学发光免疫试剂进行性能评估。方法参照临床实验室标准化委员会(CLSI)EP15-A3、EP15-A2、EP6-A、EP17-A2、EP7-A3文件进行精密度、准确度、线性范围、空白限、干扰和交叉特异性验证,并与罗氏NT-proBNP电化学发光试剂进行相关性评价。结果该试剂批内批间精密度<5%。准确度的相对偏差<8%。线性范围为4.31~42706.46pg/mL。空白限为≤5.00pg/mL。生物素浓度≤15ng/mL时无交叉反应。血红蛋白浓度为≤1i 500mg/dL、三酰甘油浓度为≤2250mg/dL、胆红素浓度为≤37.5mg/dL时,对试剂无干扰。该试剂与罗氏NT-proBNP电化学发光试剂的检测结果具有显著相关性(Y=1.082 X-9.823,R 2=0.995,P<0.05)。结论该国产NT-proBNP检测试剂性能优异,与罗氏NT-proBNP电化学发光检测试剂具有良好的相关性,且在抗干扰能力和线性范围方面更加优秀,具备临床推广价值。

Objective To conduct a performance evaluation for a domestic NT-proBNP chemiluminescence immune kit.Methods We evaluated the precision,accuracy,linear range,blank limit,interference immunity and cross-reactivity according to the Clinical and Laboratory Standards Institute(CLSI)guidelines(EP15-A3,EP15-A2,EP6-A,EP17-A2,EP7-A3).Moreover,a correlation analysis between the domestic NT-proBNP chemiluminescence immune kit and a ROCH NT-proBNP electrochemical chemiluminescence kit was conducted.Results Consequences of precision of intra-assay and inter-assay were less than 5%.For accuracy,the relative difference was less than 8%.The linear range was form 4.31 pg/mL to 42706.46 pg/mL.The blank limit was less than 5.00 pg/mL.No cross-reactivity was observed when the biotin concentration was less than or equal to 15ng/mL.Interfering Chemicals had no significant effect on domestic NT-proBNP chemiluminescence immune kit(Hemoglobin concentration≤1500mg/dL,triglyceride concentration≤2250mg/dL,bilirubin concentration≤37.5mg/dL).A good correlation was observed between domestic NT-proBNP chemiluminescence immune kit and ROCH NT-proBNP electrochemical chemiluminescence kit(Y=1.082 X-9.823,R 2=0.995,P<0.05).Conclusion The domestic NT-proBNP chemiluminescence immune kit shows an excellent property and is correlated well with ROCH NT-proBNP electrochemical chemiluminescence kit.Comparing with ROCH kit,the domestic NT-proBNP chemiluminescence immune kit has a better performance in linear range and anti-interference,deserving future clinical applications.