自制电化学发光检测N末端B型利钠肽原室内质控品及应用评价

The comparison and evaluation of the self-developed control products and the internal quality control products detection of NT-proBNP by electrochemiluminescence

目的探讨制备电化学发光检测N末端B型利钠肽原(NT-proBNP)室内质控品的方法。方法收集NT-proBNP检测结果较高的冠心病患者血清及NT-proBNP正常者血清,分为低值组和高值组。进行预期靶值及批内重复精度测定、批内天间不精密度测定、稳定性试验,并与罗氏公司原厂质控品比较,评估自制室内质控品与原厂质控品检测结果的偏倚是否在可接受范围内。结果自制NT-proBNP质控品日内重复性和稳定性良好、不精密度符合临床检测标准,在控范围明显小于罗氏公司提供的质控允许范围,可满足室内质控要求。结论自制NT-proBNP室内质控品可以替代进口原配质控品。

Objective To investigate the preparation of internal quality control products of NT-proBNP by electrochemiluminescence detection.Methods The serum with high and normal levels of NT-proBNP were collected and divided into low-value group and high-value group.The expected target value,inter-batch duplicability,imprecision and the stability within batch were detected.After effective verification,we evaluated the bias between self developed internal quality control products and Roche factory quality control materials by comparative test.Results The repeatability,stability and imprecision of self developed NT-proBNP were all appropriate to internal quality control products and meeting meet the clinical testing standards.The control range was significantly less than that permitted by Roche,so it can meet the internal quality control requirements.Conclusion The self developed NTproBNP internal quality control products can replace the imports quality control products.