[Clinical evaluation of a newly developed high-sensitive detection of hepatitis B virus surface antigen by a semi-automated immune complex transfer chemiluminescent enzyme immunoassay].
[Clinical evaluation of a newly developed high-sensitive detection of hepatitis B virus surface antigen by a semi-automated immune complex transfer chemiluminescent enzyme immunoassay].
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发表时间：
2013-09
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通讯作者：
K. Ohne;S. Kani;M. Ohashi;N. Shinkai;Takako Inoue;Y. Wakimoto;Yasuhito Tanaka
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作者：
K. Ohne;S. Kani;M. Ohashi;N. Shinkai;Takako Inoue;Y. Wakimoto;Yasuhito Tanaka
目的建立一种检测B型肝炎表面抗原（HBsAg）的高灵敏度半自动免疫复合物转移化学发光酶免疫分析法（ICT-CLEIA）。本研究旨在探讨ICT-CLEIA在HBV感染患者中的临床意义。方法对我院829例乙肝携带者和167例市售乙肝检测板进行ICT-CLEIA检测，（检测范围0.0005-2.5 IU/mL）与两种定量HBsAg检测系统进行了比较（Architect HBsAg QT检测[0.05-250 IU/mL]和HISCL HBsAg检测[0.03-2500 IU/mL]）和COBAS TaqMan HBV-DNA检测（CTM，2.1 Log拷贝/ml）。结果ICT-CLEIA具有良好的准确性和重复性。ICT-CLEIA对野生型和HBsAg逃逸突变体（I126 S、D144 A、G145 R）的敏感性比Architect HBsAg QT高2- 5至2- 6倍。在临床实践中，即使在急性B型肝炎的窗口期存在抗-HBs，ICT-CLEIA检测也可以检测HBsAg。在1例经Architect清除HBsAg的患者中，HBsAg可检测约9年。在骨髓移植后接受系统化疗的HBV再激活患者中，当通过PCR检测HBV-DNA时，通过ICT-CLEIA检测到HBsAg。总之，ICT-CLEIA检测不仅可以早期检测急性B型肝炎感染，而且可用于监测B型肝炎患者。
AIM A highly sensitive semi-automated immune complex transfer chemiluminescence enzyme immunoassay (ICT-CLEIA) for the detection of hepatitis B surface antigen (HBsAg) was recently developed. Our aim is to investigate clinical significance of ICT-CLEIA in patients with HBV. METHODS Of 829 HB carriers in our hospital and 167 commercial panels, performance of ICT-CLEIA(detection range 0.0005-2.5 IU/mL) was compared with two quantitative HBsAg detection systems (Architect HBsAg QT assay [0.05-250 IU/mL] and HISCL HBsAg assay [0.03-2500 IU/mL]) and COBAS TaqMan HBV-DNA assay (CTM, 2.1 Log copies/ml) using serum samples from patients or panels. RESULTS The ICT-CLEIA had good accuracy and reproducibility. The sensitivity of wild type and HBsAg escape mutants (I126S, D144A, G145R) by ICT-CLEIA was 2- -5 to 2- -6 times higher than that of Architect HBsAg QT. For clinical practice, ICT-CLEIA assay could detect HBsAg even in the presence of anti-HBs during window periods in acute hepatitis B panel. HBsAg has been detectable for around 9 years in a patient with HBsAg clearance by Architect. In a patient with HBV reactivation after bone marrow transplantation followed by systematic chemotherapy, HBsAg by ICT-CLEIA was detectable at the same time point when HBV-DNA was detected by PCR. In conclusion, the ICT-CLEIA assay permits not only an earlier detection of acute hepatitis B infection but also may be useful for monitoring hepatitis B patients.