Petchclai B, Niemhom S
Department of Pathology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
J Med Assoc Thai. 1990 Mar;73(3):124-9.
Hepatitis B e antigen (HBeAg) in sera indicates infectivity and when found during pregnancy, indicates a need for vaccination against hepatitis B virus. A sensitive test for HBeAg is needed in all hospitals but this test is expensive. Local development of enzyme-linked immunosorbent assay (ELISA) for HBeAg and its antibody (anti-HBe) was considered necessary and it was successfully conducted. The developed test was compared with ELISA test for HBeAg and anti-HBe manufactured by Organon Teknika (205 routine specimens and 103 sera positive for HBsAg) and Roche Diagnostic (160 routine specimens). The locally made and imported kits showed overall agreement of 97.5 to 98.1 per cent and the locally made test was always slightly more sensitive. The local test was also rapid, reproducible, and specific. The development lead to self reliance on ELISA test for HBeAg and anti-HBe.
血清中的乙肝e抗原（HBeAg）表明具有传染性，在孕期检测到该抗原则表明需要接种乙肝病毒疫苗。所有医院都需要一种检测HBeAg的灵敏方法，但这种检测方法成本高昂。因此，自行研发酶联免疫吸附测定（ELISA）法检测HBeAg及其抗体（抗-HBe）显得十分必要，并且该研发已成功完成。将研发出的检测方法与Organon Teknika公司生产的检测HBeAg和抗-HBe的ELISA试剂盒（205份常规标本和103份HBsAg阳性血清）以及罗氏诊断公司生产的试剂盒（160份常规标本）进行比较。国产试剂盒与进口试剂盒的总体一致性为97.5%至98.1%，并且国产检测方法的灵敏度总是略高一些。国产检测方法还具有快速、可重复和特异性强的特点。该研发成果实现了在HBeAg和抗-HBe检测方面的自给自足。
