便携式 Celercare M1分析仪 CRP 检测的性能验证

摘要

目的：对 Celercare M1分析仪定量测定 C-反应蛋白（CRP）的分析性能进行验证。方法根据美国临床和实验室标准协会（CLSI）标准方案，对 CRP 测定方法的线性范围、精密度、准确度、干扰试验以及方法比对等方面进行验证。结果 CRP 检测方法在0．5～200 mg／L 范围内线性良好，回归方程为Y ＝0．979X ＋0．456。CRP 低值和高值批内精密度变异系数（CV）分别为5．9％、2．0％；日间 CV 分别为6．3％、2．2％。准确度良好，CRP 低值和高值结果的相对偏差分别为2．3％、0．7％。当血清中胆红素水平不高于340μmmol／L、三酰甘油不高于10 mmol／L 和血红蛋白不高于8 g／L 时，对 CRP 水平的测定没有明显的干扰。Celercare M1分析仪（Y ）和 IMMAGE 800（X）测定 CRP 的回归方程为Y ＝0．944X ＋0．206，r2＝0．996（P ＜0．05）。Celercare M1分析仪在 CRP 3个医学决定水平（3、10、100 mg／L）的相对偏倚分别为1．0％、4．0％和5．0％，小于1／2总允许误差。结论Celercare M1分析仪定量测定CRP 的线性范围、精密度、准确度、干扰性等分析性能良好，可被临床所接受。%Objective To verify the analytical performance of the portable Celercare M1 analyzer in the C-reactive protein(CRP) quantitative determination.Methods According to the standard program of the American Clinical and Laboratory Standards Insti-tute (CLSI),The portable Celercare M1 analyzer was performed the verification on the CRP detection in the aspects of the linearity range,precision,accuracy,interference test and method comparison.Results The CRP detection showed good linearity in the range of 0.5-200 mg/L and the regression equation was Y =0.979X +0.456.The within-run coefficients of variation(CV)of samples with low and high CRP levels were 5.9% and 2.0%,respectively.The between-day CV of samples with low and high CRP levels were 6.3% and 2.2%,respectively.The accuracy of the assay was admirable,and bias of CRP results at low and high levels were 2.3% and 0.7%,respectively.No significance interference was observed when serum bilirubin ≤340 μmol/L,triglyceride ≤10 mmol/L and hemoglobin ≤8 g/L in this method.The regression equation of Celercare M1 analyzer(Y )and the IMMAGE 800 (X) for detecting CRP was Y =0.944X +0.206,R 2 =0.996(P <0.05).The relative bias of CRP results in three medical decision levels (3,10,100 mg/L)was 1 .0%,4.0% and 5.0%,repectively,which was lower than 1/2 of total error allowance.Conclusion The linearity,precision,accuracy and interference of the Celercare M1 analyzer in CRP determination are admirable and can be accepted in clinical practice.