对31种乙型肝炎病毒表面抗原酶联免疫试剂盒的分析灵敏度评价

辜文洁; 黄维金; 周诚; 吴星; 蓝海云; 姚昕; 林京香; 李河民; 梁争论; 庄辉

Abstract

辜文洁,黄维金,周诚,吴星,蓝海云,姚昕,林京香,李河民,梁争论,庄辉.对31种乙型肝炎病毒表面抗原酶联免疫试剂盒的分析灵敏度评价[J].Chinese journal of Epidemiology,2009,30(8):841-844

对31种乙型肝炎病毒表面抗原酶联免疫试剂盒的分析灵敏度评价

Evaluation on the analytical sensitivity of 31 HBsAg enzyme immunoassay kits

Received:February 03, 2009

DOI：

KeyWord: 乙型肝炎病毒酶联免疫试验灵敏度血清型

English Key Word: Hepatitis B virus Enzyme immunoassay Sensitivity Serotype

FundProject:国家"十五"科技攻关计划(2004BA718B02);北京市科技计划(D08050700650805)

Author Name	Affiliation	E-mail
GU Wen-jie	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
HUANG Wei-jin	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
ZHOU Cheng	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
WU Xing	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
LAN Hai-yun	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
YAO Xin	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
LIN Jing-xiang	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
LI He-min	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
LIANG Zheng-lun	National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China
ZHUANG Hui	北京大学医学部	zhuangbmu@126.com

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Abstract:

目的评价乙型肝炎病毒表面抗原(HBsAg)酶联免疫(EIA)试剂盒的分析灵敏度.方法对2007年6月至2008年6月申报批批检验的31种HBsAg EIA试剂盒,应用国家参考品进行检测,并用国家参考品中的灵敏度标准品,建立浓度和吸光度(A)值双对数曲线,将各试剂盒的Cut-off值代入曲线方程,计算其分析灵敏度,然后进行比较.结果对27个国内厂家(351批)和4个国外厂家(27批)HBsAg EIA试剂盒进行分析,其中2个批次国产试剂盒的灵敏度低于国家要求的质量标准,总符合率为99.43%(349/351).国产试剂盒对adr、adw、ay血清型的分析灵敏度均值分别为0.307、0.419、0.513 ng/ml,差异有统计学意义(F=97.30,P<0.01);进口试剂盒的分析灵敏度均值分别为0.054、0.066、0.050 ng/ml,差异无统计学意义(F=0.65,P>0.05).进口试剂盒各血清型分析灵敏度均高于国产试剂盒(P<0.01).部分国产试剂盒与进口试剂盒对相同血清型的分析灵敏度差异有统计学意义.同一厂家试剂盒加酶后孵育30min和60min,其血清型分析灵敏度差异无统计学意义(P>0.05);同一厂家生产的试剂盒显色10 min和15 min,其血清型分析灵敏度的差异有统计学意义(P<0.01).结论国产试剂盒应提高分析灵敏度,特别是对adw和ay血清型.

English Abstract:

Objective To study the analytical sensitivity on 31 HBsAg enzyme immunoassy (EIA) test kits.Methotis Thirty one HBsAg EIA kits produced by domestic or overseas manufactories and applied for approval during May 2007 to May 2008,were evaluated using the national reference panels.The hyperbolic curve of the log A value and log concentration for the national sensitivity standards was established.The cut-off value of each kit was substituted into the curvilinear equation to determine the analytical sensitivity which was compared between different HBsAg EIA kits.Results Twenty seven(351 lots) domestic and 4(27 lots) overseas kits were compared.Among 378 lots of the 31 HBsAg EIA kits,only 2 lots of the domestic kits had a lower sensitivity when tested with the national HBsAg reference panels,with an average approvalr ate of 99.43%(349/351).The mean analytical sensitivity of the domestic kits for adr,adw,ay serotypes were 0.307,0.419,0.513 ng/ml,respectively.There was a significant difierence between serotypes (F=97.30,P<0.01).The mean analytical sensitivity of the overseas kits for adr,adw,ay serotypes were 0.054,0.066,0.050 ng/ml respectively,with no significant difference between serotypes(F=0.65,P>0.05).The analytical sensitivity of the overseas kits for all the three serotypes was higher than that of the domestic kits(P<0.01).There was no significant difference found between the analytical sensitivities of the kits produced by the same manufactory using 30- or 60- minute incubation of detection(P>0.05).In contrast,there was significant diffefence noticed between the analytical sensitivities of the kits produced by the same manufactory when tested for 10 or 15- minute coloration of the results(P<0.01).Conclusion Analytical sensitivity of the HBsAg EIA domestic kits should be further improved,especiatry for detecting adw and ay serotypes.

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