[Comparison of nine different qualitative HBsAg assay kits].
[Comparison of nine different qualitative HBsAg assay kits].
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DOI：
10.3343/kjlm.2010.30.2.178
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发表时间：
2010-04
期刊：
影响因子：
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通讯作者：
Jin-young Yang;Jong Hyun Kim;Yoon-Ji Kim
中科院分区：
文献类型：
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作者：
Jin-young Yang;Jong Hyun Kim;Yoon-Ji Kim
背景在B型肝炎病毒（HBV）感染流行的韩国，定性的B型肝炎表面抗原（HBsAg）检测试剂盒仍然被普遍使用。HBsAg的准确检测对HBV感染的诊断和预防起着至关重要的作用，特别是在流行区。本研究的目的是比较9个定性HBsAg检测试剂盒的检测灵敏度。方法制备7份HBsAg浓度为0.14 ~ 29.96IU/mL的混合血清。通过定量HBsAg检测试剂盒Architect HBsAg（Abbott Laboratories，爱尔兰）测定各合并血清的HBsAg浓度。全自动HBsAg检测试剂盒包括Elecsys HBsAg（Roche Diagnostics，德国）和Immulite 2000 HBsAg（DPC，USA），快速检测试剂盒包括5种免疫层析法（伊卡）试剂盒和2种反向被动血凝法（RPHA）试剂盒。结果Elecsys HBsAg（Roche Diagnostics）在0.14IU/mL混合血清中检测结果为阳性，而Immulite 2000 HBsAg（DPC）在0.14IU/mL混合血清中为阴性。尽管伊卡试剂盒在不同检测试剂盒中显示不同的结果，但在HBsAg浓度≤ 1.89 IU/mL的合并血清中，所有试剂盒均显示阴性结果。两种RPHA试剂盒在HBsAg浓度≤ 7.98 IU/mL的合并血清中显示阴性结果。结论：尽管ICA比RPHA更敏感，但它们对HBsAg的敏感性不同，灵敏度低于自动免疫分析试剂盒。因此，在HBsAg筛查试验中应慎用ICA和RPHA，其敏感性有待提高。
BACKGROUND Qualitative hepatitis B surface antigen (HBsAg) assay kits are still commonly used in Korea where hepatitis B virus (HBV) infection is endemic. The accurate determination of HBsAg plays a crucial role in the diagnosis and prevention of HBV infection, especially in endemic areas. The aim of this study was to compare the detection sensitivities of 9 qualitative HBsAg assay kits. METHODS Seven pooled sera with HBsAg concentration ranging from 0.14 IU/mL to 29.96 IU/mL were prepared. The HBsAg concentration of each pooled serum was determined by a quantitative HBsAg assay, Architect HBsAg (Abbott Laboratories, Ireland). The fully automated immunoassay kits included Elecsys HBsAg (Roche Diagnostics, Germany) and Immulite 2000 HBsAg (DPC, USA) and the rapid tests included 5 immunochromatographic assay (ICA) kits and 2 reverse passive hemagglutination assay (RPHA) kits. RESULTS Elecsys HBsAg (Roche Diagnostics) showed positive result in pooled serum with HBsAg concentration of 0.14 IU/mL, but Immulite 2000 HBsAg (DPC) showed negative result in the same concentration. Although ICA kits showed variable results among different assay kits, all of them showed negative results in pooled sera with HBsAg concentration of < or = 1.89 IU/mL. Two RPHA kits showed negative results in pooled sera with HBsAg concentration of < or = 7.98 IU/mL. CONCLUSIONS Although ICAs were more sensitive than RPHAs, they had variable sensitivities for HBsAg and were less sensitive than the automated immunoassay kits. Therefore, ICAs and RPHAs should be used with caution in the screening tests for HBsAg and their sensitivities need to be improved.