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Development of an economic and efficient strategy to detect HBsAg: Application of "gray-zones" in ELISA and combined use of several detection assays

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单位: [1]Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [2]Division of Clinical Immunology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China
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关键词: Hepatitis B virus (HBV) Hepatitis B surface antigen (HBsAg) Gray-zone diagnosis Immunoassay

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Background: ELISA and CMIA are commonly used for detection of HBsAg. However, few investigations have been performed to evaluate their value in clinical practice, especially when jointly used. A reasonable and economic HBsAg testing algorithm is in great need. Methods: A total of 161,426 specimens in China were tested for 5 serum HBV markers with commonly used ELISA kits. 498 of these specimens were further tested for HBsAg by another ELISA kit, a CMIA kit and an HBsAg confirmatory assay. Results: The sensitivities of the 2 ELISA kits were 76.21% and 88.42%, respectively. However, when using "gray-zones", the sensitivities were significantly improved to 97.43% and 96.43%. Furthermore, the combined use of the 2 ELISA kits and their "gray-zones" improved the sensitivity to 99.04%. Nevertheless, 2.91% of the samples with S/CO values below the lower "gray-zone" limits were reactive by the CMIA kit and then confirmed as HBsAg positive. However, 71.43% of the samples with HBsAg values within 0.05 and 0.10 U/ml detected by the CMIA kit could not be confirmed. Conclusions: As a rational and economic strategy, combined use of "gray-zones" in ELISA and several different detection assays can significantly increase the efficiency of HBsAg detection. (C) 2011 Elsevier B.V. All rights reserved.

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基金编号: 2007BA105B09

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出版当年[2010]版:
大类 | 3 区 医学
小类 | 2 区 医学实验技术
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 医学实验技术
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出版当年[2009]版:
Q1 MEDICAL LABORATORY TECHNOLOGY
最新[2023]版:
Q2 MEDICAL LABORATORY TECHNOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2009版] 出版当年五年平均 出版前一年[2008版] 出版后一年[2010版]

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第一作者单位: [1]Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China
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通讯机构: [1]Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [*1]Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,1095# Jiefangdadao,Wuhan 430030,China
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