摘要
利用羊抗人IgM,基因工程表达的乙型肝炎X抗原和酶标抗-HBx单克隆抗体,建立了检测血清中抗-HBx IgM充体的ELISA双夹心法,并进行了初步应用。实验结果表明,此方法的特异性强,稳定性及重复性好(批内变异系数8.64%,批间变异系数10.60%,重复率为100%),且不受血清中抗-HBc IgM、抗-HAV IgM及类风湿因子的影响。由于目前国内外都没有抗-HBx IgM标准品,故对方法的敏感性没有报道。
In the present experiment, an antibody-capture sandwich ELISA was estab lished for detection of IgM antibodies to hepatitis B virus X antigen (HBxAg) in serum samples from HB patients using goat anti-human IgM antibodies, recombinant HBxAg and HRP-labelled monoclonal anti-HBx antibodies. The assay was shown to have good specificity, stability(intraassay variationcoefficient 8. 64%,interassay variation coefficient 10.60), and reproducibility (100%) and no false positive reaction was detected of anti-HAV IgM, anti-HBc IgM and rheumatoid Jactor (RF) in human serum samples. However, we, can offer no information on the sensitivity of the ELISA as established in the present experiment because no standard anti-HBx IgM antibodies are available.