Cha Young Joo, Yang Joo Suk, Chae Seok Lae
Department of Laboratory Medicine, College of Medicine, Chung-Ang University, Seoul, Korea.
Korean J Lab Med. 2006 Feb;26(1):52-7. doi: 10.3343/kjlm.2006.26.1.52.
We evaluated three indigenously produced immunochromatography (ICA) kits for the rapid detection of hepatitis B surface antigen (HBsAg) and antibody to HBsAg (anti-HBs) by comparing them with a microparticle enzyme immunoassay (MEIA).
HBsAg and anti-HBs were tested by the ICA kits manufactured by three domestic companies, SD HBsAg and Anti-HBs (Standard Diagnostics, Inc., Yongin, Korea); Asan Easy Test(R) HBsAg and Anti-HBs (Asan Pharm Co., Ltd., Whasung, Korea); and GENEDIA(R) HBsAg Rapid Device and Anti-HBs Rapid Device (Green Cross MS, Inc., Yongin, Korea).
Results by ICA agreed completely with those of MEIA in all the 20 HBsAg-negative sera and in all the anti-HBs-negative sera except one sample. Among the 20 HBsAg-positive sera by MEIA, 17 were positive by ICA using Green Cross MS, 16 using Asan Pharm Co., and 13 using SD and reverse passive hemagglutination. Among the 20 anti-HBs-positive sera by MEIA, 19 were positive by ICA using Green Cross MS and Asan Pharm Co., 17 using SD, and 18 by passive hemagglutination. Elapsed time for the control and test line to be visualized in ICA might be longer and the color of the lines lighter when using SD than Green Cross MS or Asan Pharm Co.
Three indigenously produced ICA kits are as sensitive as MEIA for the detection of anti-HBs, but are less sensitive than MEIA for HBsAg. The ICA kits for the rapid detection of HBsAg might be recommended for a limited use in the clinical laboratory.
我们通过将三种国产免疫层析（ICA）试剂盒与微粒酶免疫分析（MEIA）进行比较，评估其用于快速检测乙型肝炎表面抗原（HBsAg）和乙型肝炎表面抗原抗体（抗-HBs）的性能。
使用三家国内公司生产的ICA试剂盒检测HBsAg和抗-HBs，分别为SD HBsAg和抗-HBs（标准诊断公司，韩国龙仁）；Asan Easy Test® HBsAg和抗-HBs（阿山制药有限公司，韩国华城）；以及GENEDIA® HBsAg快速检测装置和抗-HBs快速检测装置（绿十字MS公司，韩国龙仁）。
在所有20份HBsAg阴性血清以及除一份样本外的所有抗-HBs阴性血清中，ICA检测结果与MEIA完全一致。在MEIA检测为阳性的20份HBsAg阳性血清中，使用绿十字MS公司产品的ICA检测有17份为阳性，使用阿山制药有限公司产品的有16份为阳性，使用标准诊断公司产品及反向被动血凝试验的有13份为阳性。在MEIA检测为阳性的20份抗-HBs阳性血清中，使用绿十字MS公司和阿山制药有限公司产品的ICA检测有19份为阳性，使用标准诊断公司产品的有17份为阳性，采用被动血凝试验的有18份为阳性。使用标准诊断公司产品时，ICA中对照线和检测线显色的耗时可能更长，且线条颜色比使用绿十字MS公司或阿山制药有限公司产品时更浅。
三种国产ICA试剂盒检测抗-HBs的敏感性与MEIA相当，但检测HBsAg的敏感性低于MEIA。用于快速检测HBsAg的ICA试剂盒可能仅建议在临床实验室有限使用。
