[1]何 谦,杨锐华,王 琪.非配套脂蛋白试剂的使用性能验证[J].现代检验医学杂志,2016,31(01):125-127.[doi:10.3969/j.issn.1671-7414.2016.01.036]
　HE Qian,YANG Rui-hua,WANG Qi.Performance Verification of LP(a)Reagents in Clinical Laboratory[J].Journal of Modern Laboratory Medicine,2016,31(01):125-127.[doi:10.3969/j.issn.1671-7414.2016.01.036]
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非配套脂蛋白试剂的使用性能验证()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第31卷
期数:
2016年01期
页码:
125-127
栏目:
研究简报·实验技术
出版日期:
2016-01-25

文章信息/Info

Title:
Performance Verification of LP(a)Reagents in Clinical Laboratory
作者:
何 谦; 杨锐华; 王 琪
西安交通大学医学院第二附属医院检验科,西安 710004
Author(s):
HE Qian; YANG Rui-hua; WANG Qi
Department of Clinical Laboratory, the Second Hospital of Xi'an Jiaotong University School of Medicine,Xi'an 710004,China
关键词:
脂蛋白(a);  免疫透射比浊法;  自动分析
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2016.01.036
文献标志码:
A
摘要:
目的 对4种应用于自动生化分析仪的免疫透射比浊法检测血脂蛋白(a)[LP(a)]试剂进行分析性能验证,并初步应用于临床。方法 在Olympus AU5800自动生化分析仪上对英国RANDOX、浙江夸克、北京利德曼和北京九强公司生产的免疫透射比浊法LP(a)试剂(标为A,B,C,D)进行性能验证, 对4种试剂的精密度、线性范围、准确度、干扰因素(VC,胆红素、血红蛋白、乳糜)进行评估。结果 试剂A,B,C,D的批内CV分别为0.64%～1.18%,3.59%～4.75%,1.33%～3.05%和1.43%～2.01%,批间CV分别为1.04%～1.7%,3.81%～4.93%,2.16%～4.76%和2.33%～3.21%,均小于试剂盒声明不精密度; 线性范围分别为82～923 mg/L(r2=0.997),130～935 mg/L(r2=0.996 4),120～1 025 mg/L(r2=0.992 1)和117～943 mg/L(r2=0.999 5),线性相关均良好。试验浓度内的4种干扰物(VC≤10 mg/dl,Hb≤200 mg/dl,TBIL≤40 mg/dl,TG≤500 mg/dl)对试剂A和试剂D无显著干扰(偏差<±10%),但是VC≥5 mg/dl,TG≥250 mg/dl对试剂B有干扰,TG≥250 mg/dl对试剂C有干扰。4种试剂检测定值血脂质控品,与靶值偏差分别为-8.07%,1.34%,-8.05%和7.38%,可满足临床需求。结论 应用于自动生化分析仪的4种测定LP(a)试剂盒,具有较高的精密度,可满足临床测试要求,但抗干扰能力存在一定差异。
Abstract:
Objective To validate the analytical performance of four LP(a)reagents with Immunoturbidimetry method used on the automatic biochemistry analyzer for preliminary clinical application.MethodsThe performance of four LP(a)reagents(labeled as A,B,C,D)with method from RANDOX,Zhejiang Kuake Co.,Beijing Leadman Co. and Beijing JiuqiangCo.on Olympus AU5800 automatic biochemistry analyzer were assessed.The precision,linearity range,accuracy,disturbance(vitamin C,bilirubin,hemoglobin,TG)were assessed.Results The within-run CVs of thefour reagents(A,B,C and D)were 0.64%～1.18%,3.59%～4.75%,1.33%～3.05% and 1.43%～2.01% respectively.The between-run CVs in A,B,C and D were 1.04%～1.7%,3.81%～4.93%,2.16%～4.76% and 2.33%～3.21% respectively,lower than the stated.The linearity range was 82～923 mg/L(r2=0.997),130～935 mg/L(r2=0.996 4),120～1025 mg/L(r2=0.992 1)and 117～943 mg/L(r2=0.999 5)in the four reagents,which demonstrated a soundlinear correlation.For interference tests,no remarkable interferences(<±10%)of reagent A and reagent D were detected when Vitamin C≤10 mg/dl,hemoglobin≤200 mg/dl,bilirubin≤40 mg/dl and TG≤500 mg/dl.Interference of reagent B was found when VC≥5 mg/dl,TG≥250 mg/dl and when TG≥250 mg/dl reagent C was interfered significantly.The four LP(a)reagents were used to detect the lipid control,and the deviations of the target value were -8.07%,1.34%,-8.05% and7.38% respectively.Conclusion When used in automatic biochemical analyzer,the four LP(a)reagents showed high precision.The four reagents are all able to meet clinical test requirements,nevertheless,anti-interference capability were different.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:何 谦(1971-),女,博士,主任技师,从事临床生化和免疫学研究,E-mail:heqian1971@163.com。
更新日期/Last Update: 2016-01-20