5种 C 反应蛋白快速检测系统检测性能比较

摘要

目的：评价目前常用的5种 C 反应蛋白（CRP）快速检测系统的分析性能。方法对5种 CRP 快速检测系统（Uppergold U2金标斑点法定量读数仪、NEPHSTAR 特定蛋白分析仪、ABX Micros CRP200全自动血液分析仪、i-CHROMA Reader 免疫荧光分析仪和 QuikRead 101型检测系统，均使用原厂配套试剂；以 A、B、C、D、E 随机顺序代表）进行不精密度[变异系数（CV）]、准确度、线性、抗干扰能力性能评价，对参考区间进行验证，并以 Dade Behring BN ProSpec 全自动血浆蛋白分析系统（简称 DADE 系统）作为参照系统进行比较。结果5种 CRP 快速检测系统的批内精密度和批间精密度为1.01%～16.91%，与厂商声明相符，但较 DADE 系统差。Passing-Bablok 回归分析显示5种 CRP 快速检测系统与 DADE 系统回归方程的斜率为0.88～1.73，A、B、C 3种 CRP 快速检测系统与 DADE 系统的相关性良好，而 D、E 2种 CRP 快速检测系统与 DADE 系统的相关性则较差。以 CRP=50 mg/L 为临界值，5种 CRP 快速检测系统与 DADE 系统的一致率为92.4%～100%。4种 CRP 快速检测系统的线性范围为5～160 mg/L，1种为5～100 mg/L。1500 FTU 乳糜、0.2 mg/L 游离型胆红素（FBil）、0.2 mg/L 结合型胆红素（CBil）和5 g/L 血红蛋白（Hb）对检测无干扰，5种 CRP 快速检测系统的干扰率均<10%。参考区间验证结果显示各检测系统的数据均在厂方提供的参考区间内。结论5种快速检测系统的主要分析性能能够满足临床需求，但5种 CRP 快速检测系统的结果与 DADE 系统之间存在一定的偏倚，在解释临床结果时应予考虑。%Objective To evaluate the performances of 5 common systems for C-reactive protein(CRP) determination. Methods The imprecision [coefficient of variation(CV)],accuracy,linearity and anti-interference ability of 5 systems for CRP determination were evaluated. The 5 systems included Uppergold U2 gold spot method system,NEPHSTAR specific protein analyzer,ABX Micros CRP200 automatic blood analyzer,i-CHROMA Reader immune fluorescence analyzer and QuikRead 101 detecting system. Their original reagents were used. The 5 systems were labelled as A,B,C,D and E in turn. The reference range was validated. The results were compared with those of Dade Behring BN ProSpec automatic system(DADE). Results The within-run and between-run precisions of the 5 systems were 1.01%-16.91%,which met the requirements from manufacturers,but they were lower than those of DADE. Passing-Bablok regression analysis showed that the regression equation slopes between DADE and the 5 systems were 0.88-1.73. The correlations were good between DADE and A,B,C systems,but the correlations were poor between DADE and D,E systems. For 50 mg/L CRP as cut-off value,the consistency of the 5 systems for CRP determination with DADE was 92.4%-100%. The linear range of 4 systems was 5-160 mg/L,and the linear range of 1 system was 5-100 mg/L. The interference rates of 1 500 FTU chyle,0.2 mg/L free bilirubin(FBil),0.2 mg/L conjugated bilirubin(CBil)and 5 g/L hemoglobin(Hb)were <10%. The reference value met the requirements from manufacturers. Conclusions The performances of the 5 systems are good. However,there is a bias between the 5 systems and DADE system,which should be considered in clinic.