姜剑巍，　杨　宇，　应春妹

(1. 上海交通大学医学院附属仁济医院检验科，上海 200127；

2.上海奥普生物医药有限公司，上海 201203；3.复旦大学附属妇产科医院，上海 200011)

乳胶增强免疫散射比浊法检测血清淀粉样蛋白A的应用评价

姜剑巍1，杨宇2，应春妹3

(1. 上海交通大学医学院附属仁济医院检验科，上海 200127；

2.上海奥普生物医药有限公司，上海 201203；3.复旦大学附属妇产科医院，上海 200011)

摘要：目的建立乳胶增强散射免疫比浊法检测血清淀粉样蛋白A(SAA)的即时检验(POCT)方法，并对该法的精密度、线性、准确度等进行评价。方法建立乳胶增强免疫比浊法测定SAA的POCT方法，并根据美国临床实验室标准化协会(CLSI)相关文件对建立的POCT方法进行方法学评价。结果本法的分析灵敏度为3.52 mg/L；批内变异系数(CV)<8%、日间CV<10%；抗干扰性较强，血红蛋白≤4.0 g/L、胆红素≤400 μmol/L、类风湿因子≤1 621 U/L、甘油三酯≤10 mmol/L对测定无影响；与进口N Latex SAA试剂相关性良好(Y=1.052 1X+0.001 5，r=0.998 3)；线性范围为5～200 mg/L。结论本法具有简单、快速(3 min内完成检测)的特点，各项分析指标均符合要求，可用于临床患者血清标本的检测。

关键词：淀粉样蛋白A；血清；乳胶增强免疫比浊法；即时检验

中图分类号：

文章编号：1673-8640(2015)01-0049-04R446.1

文献标志码：码：A

DOI：10.3969/j.issn.1673-8640.2015.01.012

Abstract:ObjectiveTo establish the analysis performance of serum amyloid A (SAA) detected by latex-enhanced immunonephelometry method with point-of-care test (POCT), and to evaluate precision, linearity, accuracy and so on. MethodsAccording to relevant documents of the Clinical and Laboratory Standards Institute (CLSI)， the methodological evaluation was performed. ResultsThe sensitivity of this method was 3.52 mg/L. The within-run and inter-day coefficients of variation (CV) of this method were <8% and <10%, respectively, with strong anti-interference ability. When the level of hemoglobin was ≤4.0 g/L, the level of bilirubin was ≤400 μmol/L, the level of rheumatoid factor was ≤1 621 U/L, and the level of triglyceride was ≤10 mmol/L, there was no influence on the results. There was a good correlation with that of imported N Latex SAA assay (Y=1.052 1X+0.001 5, r=0.998 3). The detection linear range of this method was 5-200 mg/L. ConclusionsThe latex-enhanced immunonephelometry method for SAA is convenient, and it can be finished within 3 min. Its performance meets the requirements for in vitro diagnostic reagents, and it is suitable for the detection of serum samples in clinical use.

作者简介：姜剑巍，男，1983年生，主要从事临床检验工作。

通讯作者：应春妹，联系电话：021-63455050。

收稿日期：(2014-02-17)

Application evaluation of latex-enhanced immunonephelometry method to determine serum amyloid AJIANGJianwei1，YANGYu2，YINGChunmei3.(1.DepartmentofClinicalLaboratory，RenjiHospital，ShanghaiJiaotongUniversitySchoolofMedicine，Shanghai200127，China; 2.ShanghaiUpperBio-TechPharmaCo.，Ltd.，Shanghai201201,China; 3.ObstetricsandGynecologyHospitalofFudanUniversity,Shanghai200011,China)

Key words: Amyloid A；Serum；Latex-enhanced immunonephelometry method；Point-of-care test

血清淀粉样蛋白A(serum amyloid A protein ，SAA)是一种急性时相反应蛋白，属于载脂蛋白家族中的异质类蛋白质，相对分子质量约为12 000。在急性时相反应中，经白细胞介素(interleukin，IL)-1、IL-6和肿瘤坏死因子(tumor necrosis factor，TNF)刺激，SAA在肝脏中由被激活的巨噬细胞和纤维母细胞合成，可升高到最初浓度的100～1 000倍。与C反应蛋白 (C reactive protein，CRP) 类似，SAA是反映感染性疾病早期炎症的敏感指标，有助于诊断炎症、评估其活性、监控其活动及治疗。研究表明在病毒感染性急性期，SAA水平明显升高，而CRP升高并不明显，因此SAA是判断病毒感染灵敏而可靠的指标[1-3]。……