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学科主题: 临床检验诊断学
题名:
4种脂肪酶检测系统的性能评价
其他题名: Performance evaluation of four lipase detection systems
作者: 安崇文; 李海霞
关键词: 脂肪酶 ; 酶比色法 ; 全自动生化分析仪 ; Lipase ; Enzyme colorimetry ; Automatic biochemical analyzer
刊名: 中国实验诊断学
发表日期: 2015
期: 1, 页:1-6
收录类别: 中国科技核心期刊
文章类型: Journal Article
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Pear-son检验,偏差分析应用Bland-Altman曲线。结果 LPS在25-240 U/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15 g/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≥8 mmol/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、379 U/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、-21.1 U/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=60 U/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=180 U/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=180 U/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 the A,B,D system.By calculating expected deviation of medical decision level (Xc)showed that A,B,D systems were in line with 1/3 total allowable error (12.63%)of the biological variation set when Xc=60 U/L,the allowable deviation of B,D systems were not in the confidence interval (CI)and also less than the lower limit of the confidence interval from ex-pected deviation when Xc=180 U/L,and performance of B,D system by verified was not quite compared with the C system when the Xc=180 U/L,comparability of the results was difference and unacceptable.Conclusion There are differences between the performance of the four lipase detection system.
语种: 中文
原文出处: 查看原文
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/43547
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作者单位: 北京大学第一医院 检验科,北京,100034

Recommended Citation:
安崇文,李海霞. 4种脂肪酶检测系统的性能评价[J]. 中国实验诊断学,2015(1):1-6.
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