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Quik Read 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 Pro Spec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。1 500 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 Quik Read 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 Pro Spec 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.
出处
《检验医学》
CAS
2016年第4期293-298,共6页
Laboratory Medicine
关键词
C反应蛋白
快速测定法
免疫透射比浊法
免疫散射比浊法
C-reactive protein
Rapid determination method
Immunoturbidimetric assay
Immunonephelometric assay
