电化学发光免疫分析与酶联免疫吸附测定法应用于乙型肝炎病毒血清学检验中的效果分析

Effect analysis of electrochemiluminescence immunoassay and enzyme-linked immunosorbent assay in hepatitis B virus serologic testing

目的对比乙型肝炎病毒血清学检验过程中采用电化学发光免疫分析(ECLIA)与酶联免疫吸附测定法(ELISA)的效果。方法90例乙型肝炎患者,分别以电化学发光免疫分析、酶联免疫吸附测定法进行病毒血清学检验。对比两种诊断方法对乙型肝炎病毒[乙型肝炎病毒核心抗体(HBcAb)、乙型肝炎病毒表面抗体(HBsAb)、乙型肝炎e抗原(HBeAg)、乙型肝炎病毒表面抗原(HBsAg)、乙型肝炎病毒e抗体(HBeAb)]阳性检出率以及不同浓度下两种检验方法HBsAg重复性。结果电化学发光免疫分析对HBcAb、HBsAb、HBeAg、HBsAg、HBeAb的阳性检出率分别为85.56%、33.33%、48.89%、31.11%、64.44%;酶联免疫吸附测定法对HBcAb、HBsAb、HBeAg、HBsAg、HBeAb的阳性检出率分别为83.33%、32.22%、45.56%、27.78%、44.44%。两种检验方法对HBcAb、HBsAb、HBeAg、HBsAg的阳性检出率对比无统计学差异(P>0.05),电化学发光免疫分析对HBeAb的阳性检出率明显高于酶联免疫吸附测定法(P<0.05)。两种检验方法在高浓度HBsAg批次间重复性相近,而电化学发光免疫分析在高浓度HBsAg批次内及中、低浓度HBsAg批次间、批次内重复性均明显低于酶联免疫吸附测定法。结论乙型肝炎患者接受病毒血清学检验可首选电化学发光免疫分析,其具有检出率高、结果准确等优点,值得临床运用并推广。

Objective To compare the effect of electrochemiluminescence immunoassay(ECLIA)and enzyme-linked immunosorbent assay(ELISA)in hepatitis B virus serologic testing.Methods 90 patients with hepatitis B were subjected to virus serological testing using electrochemiluminescence immunoassay and enzyme-linked immunosorbent assay.The two diagnostic methods were compared for the positive detection rate of hepatitis B virus[hepatitis B virus core antibody(HBcAb),hepatitis B virus surface antibody(HBsAb),hepatitis B e antigen(HBeAg),hepatitis B virus surface antigen(HBsAg),and hepatitis B virus e antibody(HBeAb)]as well as the reproducibility of the two tests for HBsAg at different concentrations.Results The positive detection rates of electrochemiluminescence immunoassay for HBcAb,HBsAb,HBeAg,HBsAg,HBeAb were 85.56%,33.33%,48.89%,31.11%,64.44%respectively;the positive detection rates of enzyme-linked immunosorbent assay for HBcAb,HBsAb,HBeAg,HBsAg,HBeAb were 83.33%,32.22%,45.56%,27.78%,44.44%,respectively.There was no statistically significant difference in the comparison of the positive detection rates of HBcAb,HBsAb,HBeAg and HBsAg between the two tests(P>0.05),and the positive detection rate of HBeAb by electrochemiluminescence immunoassay was significantly higher than that by enzyme-linked immunosorbent assay(P<0.05).The reproducibility between batches of high concentration HBsAg was similar(P>0.05).In contrast,the reproducibility of electrochemiluminescence immunoassay was significantly lower than that of enzyme-linked immunosorbent assay within batches of high-concentration HBsAg as well as between batches and within batches of medium-and low-concentration HBsAg.Conclusion Electrochemiluminescence immunoassay is the preferred choice for virus serological testing in patients with hepatitis B.It has the advantages of high detection rate and accurate results,and is worthy of clinical use and promotion.