[1]丁蒙蒙,李 奎,于 林,等.人血清淀粉样蛋白A磁微粒化学发光免疫分析定量检测方法的建立及性能评价[J].现代检验医学杂志,2019,34(05):127-129.[doi:10.3969/j.issn.1671-7414.2019.05.031]
　DING Meng-meng,LI Kui,YU Lin,et al.Establishment and Performance Evaluation of the Quantitative Detection for Human Serum Amyloid A Based on Chemiluminescent Immunoassay[J].Journal of Modern Laboratory Medicine,2019,34(05):127-129.[doi:10.3969/j.issn.1671-7414.2019.05.031]
点击复制

人血清淀粉样蛋白A磁微粒化学发光免疫分析定量检测方法的建立及性能评价()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年05期
页码:
127-129
栏目:
研究简报·实验技术
出版日期:
2019-10-29

文章信息/Info

Title:
Establishment and Performance Evaluation of the Quantitative Detection for Human Serum Amyloid A Based on Chemiluminescent Immunoassay
文章编号:
1671-7414(2019)05-127-04
作者:
丁蒙蒙; 李 奎; 于 林; 李双法
(郑州安图生物工程股份有限公司,郑州 450016)
Author(s):
DING Meng-meng; LI Kui; YU Lin; LI Shuang-fa
(Autobio Diagnostics Co.Ltd,Zhengzhou 450016,China)
关键词:
人血清淀粉样蛋白A;  磁微粒化学发光;  性能指标
分类号:
R392-33
DOI:
10.3969/j.issn.1671-7414.2019.05.031
文献标志码:
A
摘要:
目的 建立人血清淀粉样蛋白A(human serum amyloid A,SAA)磁微粒化学发光免疫分析定量检测方法。方法 采用基于磁微粒化学发光免疫分析的双抗体夹心法定量检测人血液中SAA含量。评价该方法学的空白限、精密度、线性、回收率和钩状效应等分析性能指标,并用以上方法检测60例细菌或病毒感染患者血清和40例正常人血清,进行临床比对试验研究。结果 该方法的空白限为0.1 mg/L; 分析内精密度不高于5%,分析间精密度不高于10%; 在2～200 mg/L范围内,线性相关系数可达0.990; 准确度偏倚不高于15%; 回收率在100%±15%以内; 样本中SAA的含量为10 000 mg/L时,未发现钩状效应; 与西门子免疫比浊法试剂平行比对试验,回归方程为:Y=1.099 8X-2.673 9,相关系数r2为0.983 4。结论 该方法灵敏度高、精密度好、线性范围宽和临床相关性好,具有一定的临床应用价值。
Abstract:
Objective To establish a quantitative detectionmethod for human serum amyloid A(SAA)by chemiluminescence immunoassay.Methods The double antibody sandwich method based on magnetic particle chemiluminescence immunoassay was used to quantitatively detect the SAA content in human blood.The analytical performance of the established assay was further evaluated by a series of analysis,such as blank limit,precision,linearity,recovery rate and hook effect.The serum of 60 bacterial or viral infectedpatients and 40 normal human serum were detected by this method for clinical comparison test.Results The limit of blank was 0.1 mg/L.The within variance was lower than 5 percents,and days varican was lower than 10 percents.The linear range was 2～200 mg/L,and the correlation coefficient(r)was 0.990.Measurement relative bias for trueness was less than 15%.Thespiking recovery for accuracy was(100±15)%,and there was no hook effect whenthe sample with 10 000 mg/L SAA.The determination coefficient r2 was 0.983 4 in method comparison,regression equation was Y=1.099 8X-2.673 9.Conclusion The established human SAA magnetic particle chemiluminescence immunoassay quantitative detection method has high sensitivity,fast detection speed,specificity,high clinical diagnostic value.

参考文献/References:

[1] 曹琳,宋晓文,任金来,等.血清淀粉样蛋白A的研究进展[J].安徽医药,2019,23(2):221-224. CAO Lin,SONG Xiaowen,REN Jinlai,et al.Advances in research on serum amyloid A[J].Anhui Medical and Pharmaceutical Journal,2019,23(2):221-224. [2] MIWATA H,YAMADA T,OKADA M,et al.Serum amyloid A protein in acute viral infections[J].Archives of Disease in Childhood,1993,68(2):210-214. [3] 谭保林.血清淀粉样蛋白A在疾病应用中的研究进展[J].中国社区医师,2019,35(3):9-10,12. TAN Baolin.Research progress on the disease diagnosis application of serum amyloid A protein[J].Chinese Community Doctors,2019,35(3):9-10,12. [4] G(¨overU)R A,OGUZTURK H,KOSE A,et al.Prognostic value of procalcitonin,CRP,serum amyloid A,lactate and IL-6 markers in liver transplant patientsadmitted to ED with suspected infection[J].In Vivo,2017,31(6):1179-1185. [5] ABBAS M H,CHOUDHRY M N,HAMZA N,et al.Admission levels of serum amyloid a and procalcitonin are more predictive of the diagnosis of acute appendicitiscompared with C-reactive protein[J].Surgical Laparoscopy,Endoscopy & Percutaneous Techniques,2014,24(6):488-494. [6] 万颖蕾,李文静,项明洁.血清淀粉样蛋白A在感染性疾病中的诊断价值[J].诊断学理论与实践,2015,14(2):190-192. WAN Yinglei,LI Wenjing,XIANG Mingjie.Research progress on the infectious disease diagnosis application of serum amyloid A protein[J].Journal of Diagnostics Concepts Practice,2015,14(2):190-192. [7] MALLE E,DE BEER F C.Human serum amyloid A(SAA)protein:a prominent acute-phase reactant for clinical practice[J].European Journal of Clinical Investigation,1996,26(6):427-435. [8] 黄建央,沈敏敏,刘东海.血清淀粉样蛋白A两种检测方法相关性的比对及相关疾病样本检测结果分析[J].检验医学,2014,29(5):574-575. HUANG Jianyang,SHEN Minmin,LIU Donghai.Co-mparison of correlation between two methods for detecting serum amyloid A and analysis of test resultsof related diseases[J].Laboratory Medicine,2014,29(5):574-575.

备注/Memo

备注/Memo:
作者简介:丁蒙蒙(1992-),女,硕士,助理工程师,主要从事免疫检验试剂研发,E-mail:156869932@qq.com。
更新日期/Last Update: 2019-10-20