摘要
目的对RAMP200荧光免疫分析仪的性能进行评价,以符合实验室的质量要求。方法参考临床和实验室标准化协会(CLSI)系列文件,对RAMP200荧光免疫分析仪检测B型利钠肽(BNP)的总不精密度、功能灵敏度、分析测量范围、临床可报告范围、孔间偏差、生物参考区间进行验证和评价。结果 BNP浓度为80.4、1 169.6pg/mL时的天间总不精密度分别为4.90%和4.02%;功能灵敏度为10.58pg/mL;分析测量范围为10.2～1 805pg/mL;临床可报告范围为10.58～5 415pg/mL;孔间最大偏差为14.27%(厂商说明小于20%);生物参考区间验证结果为15～86pg/mL(厂商参考区间为小于100pg/mL)。结论 RAMP200荧光免疫分析仪各性能参数与厂商提供的参数基本一致,可满足临床质量要求,适用于快速床旁检验。
Objective Abiding by the laboratory quality requirement,to evaluate the performance of RAMP200 fluorescence immunoassay analyzer.Methods According to Series of documents of the American Society of Clinical and Laboratory Standards Institute（CLSI）,following six items：the total precision,functional sensitivity,analytical measurement range,reportable range,the deviation between the holes,biological reference interval of RAMP200 fluorescence immunoassay analyzer were verified and evaluated.Results When BNP concentration levels were 80.4 and 1 169.6 pg/mL,the total precisions were 4.9% and 4.02%.The functional sensitivity was 10.58 pg/mL.The analytical measurement range was from 10.2 pg/mL to 1 805.0 pg/mL.The clinical reportable range was from 10.58 pg/mL to 5 415.0 pg/mL.The maximum deviation between the hole was 14.27%.Biological reference interval was from 15 to 86 pg/mL（Vendor reference interval 100 pg/mL）.Conclusion The parameters of RAMP200 fluorescence immunoassay analyzer are consistent with the parameters provided by the vendor,so it can fit the clinical quality demand and it is suitable for the POCT.
出处
《检验医学与临床》
CAS
2013年第2期182-183,185,共3页
Laboratory Medicine and Clinic
关键词
荧光免疫分析
B型利钠肽
性能评价
fluorescence immunoassay
B-type natriuretic peptide
performance evaluation
作者简介
通讯作者，Email：WHYSA@163．net。
