N末端脑钠肽前体(NT-proBNP)定量检测试剂盒的性能评价

Performance Evaluation of NT proBNP Quantum Dot Immunofl uorescence Chromatography

验证和评价某国产N末端脑钠肽前体试剂盒(量子点免疫荧光层析法)的性能。参考美国临床和实验室标准化委员会(CLSI)制订的EP9-A2,EP6-A,EP5-A2,EP17-A2以及中华人民共和国卫生行业标准CNAS-GL037,WS/T492-2016等性能验证文件,对该试剂盒的测量正确度、最低检测限、线性范围、精密度进行验证以及评价。研究结果显示,经过试验,该试剂盒线性范围为50~35000 pg/mL,灵敏度为3.31 pg/mL。当检测浓度为250~500 pg/mL时,重复性CV<10.0%;检测浓度<250 pg/mL和>500 pg/mL时,重复性CV<15.0%。研究发现,考核试剂盒检测性能与罗氏化学发光检测试剂盒有良好的一致性,灵敏度符合企业产品技术要求,重复性良好,线性误差符合企业产品技术要求。

Validate and evaluate the performance of a domestically produced N-terminal brain natriuretic peptide precursor kit(quantum dot immunofluorescence chromatography).Referring to the performance validation documents such as EP9-A2,EP6-A,EP5-A2,EP17-A2 developed by the Clinical and Laboratory Standards Institute(CLSI)in the United States,as well as the health industry standards CNAS-GL037 and WS/T492-2016 in the People’s Republic of China,the measurement accuracy,minimum detection limit,linear range,and precision of the kit were validated and evaluated.The results showed that after testing,the linear range of the kit was 50~35000 pg/mL,and the sensitivity was 3.31 pg/mL.When the detection concentration is between 250~500 pg/mL,the repeatability CV is less than 10.0%;When the detection concentration is less than 250 pg/mL and greater than 500 pg/mL,the repeatability CV is less than 15.0%.Research has found that the detection performance of the assessment kit is consistent with that of the Roche chemiluminescence detection kit,with sensitivity meeting the technical requirements of the enterprise’s products,good repeatability,and linear error meeting the technical requirements of the enterprise’s products.