化学发光免疫分析法与酶联免疫吸附试验法检测乙肝病毒感染标志物比较

Comparison of Chemiluminescence Immunoassay and Enzyme-linked Immunosorbent Assay for Detection of HBV Infection Markers

目的比较化学发光免疫分析法与酶联免疫吸附试验法检测乙肝病毒感染标志物的价值。方法选取2020年1月-2021年5月在我站血液采集筛查,经实时荧光定量PCR确诊的70例乙肝病毒阳性样本为研究对象,采用随机数字表法分为对照组和观察组,各35例。对照组采用酶联免疫吸附试验法检测,观察组采用化学发光免疫分析法检测,比较两组乙肝病毒感染标志物检测阳性率、两组乙肝病毒感染灵敏度、特异度、准确度以及低浓度HBsAg诊断准确度。结果观察组乙型肝炎E抗体(HBeAb)、乙型肝炎表面抗原(HBsAg)、乙型肝炎E抗原(HBeAg)阳性检出率均高于对照组,差异有统计学意义(P<0.05);两组乙型肝炎表面抗体(HBsAb)、乙型肝炎核心抗体(HBcAb)阳性检出率比较,差异无统计学意义(P>0.05);两组乙肝病毒感染标志物灵敏度、特异度、准确度比较,差异无统计学意义(P>0.05);当HBsAg低水平检测值≤1.00 ng/ml时,观察组乙肝病毒感染标志物检出率高于对照组,差异有统计学意义(P<0.05)。结论化学发光免疫分析法与酶联免疫吸附试验法在乙肝病毒感染标志物检测中均具有良好灵敏度、特异度、准确度,但是化学发光免疫分析法对乙肝病毒感染标志物检出阳性率相对较高,尤其对于早期乙肝病毒感染具有重要的临床应用价值。

Objective To compare the value of chemiluminescence immunoassay and enzyme linked immunosorbent assay in detection of hepatitis B virus infection markers.Methods A total of 70 patients with hepatitis B virus positive samples confirmed by real-time fluorescence quantitative PCR were selected from January 2020 to May 2021 in our station.They were divided into control group and observation group by random number table method,with 35 cases in each group.The control group was detected by enzyme-linked immunosorbent assay,and the observation group was detected by chemiluminescence immunoassay.The positive rate of hepatitis B virus infection markers,the sensitivity,specificity,accuracy of hepatitis B virus infection and the diagnostic accuracy of low concentration HBsAg in the two groups were compared.Results The positive detection rates of hepatitis B E antibody(HBeAb),hepatitis B surface antigen(HBsAg)and hepatitis B E antigen(HBeAg)in the observation group were higher than those in the control group,and the difference was statistically significant(P<0.05).There was no significant difference in the positive detection rates of hepatitis B surface antibody(HBsAb)and hepatitis B core antibody(HBcAb)between the two groups(P>0.05).There was no significant difference in sensitivity,specificity and accuracy of hepatitis B virus infection markers between the two groups(P>0.05).When the low-level detection value of HBsAg was≤1.00 ng/ml,the detection rate of HBV infection markers in the observation group was higher than that in the control group,and the difference was statistically significant(P<0.05).Conclusion Chemiluminescence immunoassay and enzyme-linked immunosorbent assay have good sensitivity,specificity and accuracy in the detection of hepatitis B virus infection markers,but the positive rate of chemiluminescence immunoassay for hepatitis B virus infection markers is relatively high,especially for early hepatitis B virus infection.