4种脂肪酶检测系统的性能评价  

Performance evaluation of four lipase detection systems

作　　者：安崇文[1] 李海霞[1] 

机构地区：[1]北京大学第一医院检验科,北京100034

出　　处：《中国实验诊断学》2015年第1期1-6,共6页Chinese Journal of Laboratory Diagnosis

基　　金：国家科技支撑计划基金资助项目(2012BAH24F00)

摘　　要：目的评估4种脂肪酶(Lipase,LPS)检测系统的分析性能。方法方法学评价研究。应用美国临床和实验室标准化协会(CLSI)EP5-A2、EP15-A2、EP7-A2、EP6-A、EP9-A2方法验证4种脂肪酶检测系统的精密度、正确度、抗干扰性、分析测量范围(AMR)、相关及偏差。采用美国病理学家协会(CAP)发放的室间质评物(C-A和C-B)验证不同系统检测LPS正确度。回归分析采用Passing-Bablok检验,回归线性检测采用Cusum方法,相关分析采用Pearson检验,偏差分析应用Bland-Altman曲线。结果 LPS在25-240U/L时,4种检测系统的批内CV均<TEa的1/4(9.47%),批间CV均<TEa的1/3(12.63%)。正确度验证测定美国CAP室间质评物显示仅A、C系统较为理想,其95%验证区间包含了指定均值,且符合生物学变异设定的总允许误差(TEa:<37.88%);回收试验显示除B系统高回收标本外,其它系统均未超出±10%。抗干扰性评估显示Hb≥5g/L时,对B、C系统低水平有>10%的正干扰,在15g/L时,对D系统低水平有>10%的正干扰;Bil≤600μmol/L时对4种系统均无明显干扰现象;TG≥8mmol/L时,对A、C系统均有>10%的负干扰。4种系统AMR上限分别为341、494、529、379U/L。相关分析以选取上述性能较为理想的C系统为参考对象,A、B、D与C系统比较相关性较好,r均>0.975(P<0.01),Bland-Altman偏差分析显示平均绝对偏差分别为-9.7、-21.7、-21.1U/L,平均相对偏差分别为-10.12%、-11.96%、-13.51%,计算医学决定水平(Xc)时的预期偏差显示在Xc=60U/L时,A、B、D系统均符合生物学变异设定的1/3总允许误差(12.63%),在Xc=180U/L时,B、D系统的允许偏差不在预期偏差的可信区间内且小于可信区间下限,证实B、D系统在Xc=180U/L时与C系统的性能不相当,结果可比性差,不可接受。结论 4种检测系统的性能之间存在差异。Objective To evaluate the performance for four Lipase（LPS）analysis system.Methods This study be-longs to the methodological evaluation study,Analysed four Lipase systems and their correlation and deviation compared with A system.Precision,accuracy,anti-interference,analytical measuring range （AMR）were evaluated,according to the CLSI EP5-A2,EP15-A2,EP7-A2,EP6-A,EP9-A2 guidelines.To assess the accuracy,we used the EQA samples（C-A and C-B）from CAP.Regression using Passing-Bablok,linear regression was detected by Cusum method,analysis of correlation using pearson,analysis of deviation using Bland-Altman.Results For four lipase detection systems,the within-run CVs were all 〈1/4TEa（9.47%）and the between-run CVs were all 〈1/3TEa（12.63%）when the concen-tration of LPS was 25-240 U/L.The accuracy verification testing CAP EQA material showed that A and C system re-sults met the desirable,the 9 5% verification interval that contains the specified mean value,and in accordance with the total allowable error derived from biological variation set （TEa：〈37.88%）;Recovery test shows that except for the high recovery of specimens from B system,other systems were not exceed±10%.Anti-interference analysis showed that had over 10% positive interference on the low level of B、C system while Hb≥5 g/L and on the low level of D sys-tem when Hb was 15 g/L;There was no significant interference for the four systems when Bil≤600μmol/L.It had o-ver 10% negative interference of A、C system while TG≥8 mmol/L;The upper limits of AMR for A,B,C and D sys-tem were 341,494,529 and 379 U/L respectively.Correlation analysis to select the C system the performance of ideal as the reference object,the A,B,D system correlation well with C system and the pearson correlation coefficient（r）〉0.975 （P〈 0.01）;Compared with C system,the Bland-Altman results showed that the average absolute deviation were-9.7、-21.7、-21.1 U/L and the average relative devation were-10.12%、-11.96%、-13.51% respectively for t

关 键 词：脂肪酶 酶比色法 全自动生化分析仪 

分 类 号：R446.112[医药卫生—诊断学]