奥普U2金标法定量检测C反应蛋白项目性能评价

Performance Evaluation of C-Reactive Protein Quantitative Test by Colloidal Gold Immunoassay

目的对国产金标斑点法定量读数仪奥普U2检测C反应蛋白的性能进行系统的评价。方法按照NCCLS1999年发布的EP系列文件要求对奥普u2检测C-反应蛋白项目的准确度、批内、批间精密度、功能灵敏度、稳定性、线性范围和干扰进行全面的评价。结果全血标本奥普U2与Quikread的相关性为r=0．990，血浆标本奥普U2与德灵BNⅡ及Quikread的相关性分别为r=0．978及0．985；全血高、低浓度批内精密度为6．2％和6．3％，批间精密度为5．1％和7．6％，血浆高、低浓度批内精密度为5．50％和10．8％，批问精密度为2．5％和1．1％；功能灵敏度为7mg／L；仪器使用新生产和有效期末的工作液检测CRP结果差异无统计学显著性意义（P〉0．05）；检测范围在7～133mg／L时线性回归方程Y=1．0108X-1．6364，r=0．9987；脂血（三酰甘油最高达21．5mmol／L）、胆红素（TBIL最高达242．6μmol／L）、类风湿因子（RF最高达2980IU／L）的标本对检测结果无明显影响。结论奥普U2金标斑点法定量检测CRP除功能灵敏度应修正为7mg／L外，不仅具有良好的准确度、精密度、试剂稳定性、线性范围等性能参数与其说明书中基本一致，而且与同类进口检测系统的性能无显著差异，完全适用于快速检测及床边检验（POCT）。

Objective To evaluate the performance of U2 DOT Read Meter for CRP test. Methods To evaluate the accuracy, precision,sensitivity,stability,linearity and anti-interfered ability of U2 in CRP test according to the EP series documents announced by NCCLS in 1999. Results Relationship results tested by the analyzer showed no significant difference com- pared with those tested by the U2 and BN II （r=0. 978 in serum）, U2 and Quikread（ r= 0. 990 in blood; r= O. 985 in ser- um）. Coefficients of variation of the intra-precision testing,inter-batch testing were 6.2 %, 6.3 %, 5.1% and 7.6% in blood test,and were 5.50% and 10. 8%,2.5% and 1.1% in plasma test, respectively. Functional sensitivity was 7 mg/L. There was no significant difference between different batches（P^0.05）. The practical value and the theoretical value detected by the analyzer had good linear relationship （r= 0. 998 7）. The high TG （TG≤21.5 mmol/L）, the high TBIL（TBIL≤242.6 μmol/L） and RF concentration of high level （RF〈2 980 IU/L） showed no obvious interaction to the test results. Conclusion After modifying the functional sensitivity to 7 mg/L,U2 rapid quantitative determination had well precision and accuracy, and had the advantages of low sensitivity, wide linear range, stable reagent and fast detect speed. So it is suitable for the screen of the infected patients.