A simple and rapid capillary chemiluminescence immunoassay for quantitatively detecting human serum HBsAg

A simple and rapid capillary chemiluminescence immunoassay for quantitatively detecting human serum HBsAg
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一种简单快速的毛细管化学发光免疫分析法定量检测人血清HBsAg

DOI:
10.1007/s10096-013-1910-0
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发表时间:
2013-06
期刊:
European Journal of Clinical Microbiology & Infectious Diseases
影响因子:
--
通讯作者:
Guo, Y.
Guo, Y.
中科院分区:
其他
文献类型:
--
作者:
Xiang, A.;Wei, F.;Lei, X.;Liu, Y.;Liu, Y.;Guo, Y.

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血清乙肝表面抗原(HBs-Ag)的定量检测对监测抗-HBs治疗、评价血液制品或输血的安全性具有重要意义。本研究旨在建立和评价一种基于毛细管的化学发光免疫分析方法,用于简单、快速地检测人血清中的乙肝表面抗原。建立了一种简便、快速的毛细管化学发光免疫分析法(CCIA),用于定量检测人血清中的乙型肝炎表面抗原(HBs)。对实验条件进行了优化,并用阳性(−)和阴性(HBs)人血清验证了该方法的敏感性和特异性。CCIA定量检测人血清HBs Ag水平在0.4-15.0 ng/m L,导致化学发光(CL)信号随剂量增加,灵敏度为0.3 m g/m L。对单个样品的分析只需25分钟。CCIA仅检测到乙肝表面抗原,但不检测丙型肝炎病毒(HCV)、人类免疫缺陷病毒(HIV-1)p24、密螺旋体(TP)抗原或其他血清蛋白和血脂,特异性为100%。CCIA方法重复性好,批内变异系数(CV)为6.7%,批间变异系数(CV)为7.4%。对2 80份已知的HBs Ag+或HBs Ag−临床血清样本的验证表明,CCIA检测出97.5%的HBs Ag+血清无假阳性,其灵敏度和特异度与Architect I2000SRHBs Ag法(Kappa Value = 0.983)相近。CCIA是一种简便、快速的定量检测血清乙肝表面抗原水平的方法,可用于监测抗-HBs治疗和评价输血样本的安全性。
The quantitative measurement of serum hepatitis B surface antigen (HBsAg) is important for monitoring anti-hepatitis B virus (HBV) therapy and evaluating the safety of blood products or blood transfusion. This study is aimed at generating and evaluating a capillary-based chemiluminescence immunoassay for the simple and rapid detection of human serum HBsAg. A simple and rapid capillary chemiluminescence immunoassay (CCIA) was developed using a portable analyzer for quantitatively detecting the levels of HBsAg in human serum. The experimental conditions were optimized, and the sensitivity and specificity of the CCIA were validated in positive HBsAg (HBsAg+) and negative HBsAg (HBsAg−) human sera. The CCIA quantitatively detected the levels of human serum HBsAg at 0.4–15.0 ng/mL, which resulted in dose-dependent increases in the chemiluminescence (CL) signals, with a sensitivity of 0.3 ng/mL. The assay took only 25 min for the analysis of a single sample. The CCIA only detected HBsAg, but not hepatitis C virus (HCV), human immunodeficiency virus-1 (HIV-1) p24,Treponema(TP) antigens, or other serum proteins and lipids tested with a specificity of 100 %. The CCIA for detecting HBsAg was reproducible, with a low intra-assay coefficient of variation (CV) (6.7 %) and inter-assay CV (7.4 %). The validation of 280 known HBsAg+or HBsAg−clinical serum samples revealed that the CCIA detected 97.5 % of HBsAg+sera without false-positives, with a sensitivity and specificity similar to that of the Architect i2000SRHBsAg assay (Kappa value = 0.983). The CCIA is a simple and rapid method for quantitatively measuring the levels of serum HBsAg to monitor anti-HBV therapy and evaluate the safety of blood samples for transfusion.
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发表时间: 2012
影响因子: 4.5
作者:
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DOI: 10.1016/j.biomaterials.2011.10.065
发表时间: 2012-02-01
期刊: BIOMATERIALS
影响因子: 14
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期刊: The Korean journal of laboratory medicine
影响因子: --
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DOI: 10.1111/j.1537-2995.2011.03264.x
发表时间: 2012-01-01
期刊: TRANSFUSION
影响因子: 2.9
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