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目的对Roche Cobus E601(E601)和Abott Architecti 2000(i2000)全自动免疫分析仪和酶联免疫吸咐测定(ELISA)法的HBV标志物测定结果进行对比分析。方法采用3种方法对4个批次(188、215、178、180份)共761份样本的4种HBV血清标志物---HBV表面抗原(HBsAg)、HBV表面抗原抗体(HBsAb)、HBVe抗原(HBeAg)、HBVe抗原抗体(HBeAb)进行平行检测。对于3种方法中HBeAg和HBsAg测定结果有差异的标本,采用实时定量PCR仪进行复查。结果3种方法中HBsAg的符合率最高(98.94%),其次是HBeAg(94.94%)、HBsAb(90.70%)和HBeAb(83.3%)。i2000能对HBsAg和HBsAb进行定量分析,E601只能对HBsAb进行定量分析,结果显示i2000和E601的HBsAb定量结果有很好的相关性;4种标志物测定结果中E601和i2000间的符合率都明显高于ELISA和E601(或i2000):且无论是E601还是i2000其阳性率均高于ELISA法。E601的HBeAb测定结果的阳性率在3种方法中最高(61.67%)。结论全自动免疫分析仪的HBsAg和HBsAb定量对于评估HBV疫苗接种效果与HBV复制水平有着传统ELISA方法无法比拟的作用。自动免疫分析的重复性和敏感性要好于传统ELISA。E601的HBeAb测定敏感性过高存在假阳性。
OBJECTIVE: To compare the results of HBV markers assay with Roche Cobus E601 (E601) and Abott Architecti 2000 (i2000) automated immunoassay and enzyme-linked immunosorbent assay (ELISA). Methods Four kinds of serum markers of 761 samples in four batches (188, 215, 178, 180) were tested by three methods - HBV surface antigen (HBsAg), HBV surface antigen antibody (HBsAb), HBVe Antigen (HBeAg), HBVe antigen antibody (HBeAb) for parallel detection. For the three methods in HBeAg and HBsAg measurement results were different specimens, using real-time PCR machine for review. Results The coincidence rate of HBsAg among the three methods was the highest (98.94%), followed by HBeAg (94.94%), HBsAb (90.70%) and HBeAb (83.3%). i2000 quantitative analysis of HBsAg and HBsAb, E601 only quantitative analysis of HBsAb, the results showed that i2000 and E601 HBsAb quantitative results have a good correlation; four markers in the determination of E601 and i2000 coincidence rates are Was significantly higher than that of ELISA and E601 (or i2000): and the positive rate of both E601 and i2000 was higher than that of ELISA. The positive rate of HBeAb in E601 was the highest among the three methods (61.67%). Conclusion Quantification of HBsAg and HBsAb by automated immunoassay analyzers has an incomparable effect on the evaluation of HBV vaccination and HBV replication by the traditional ELISA method. Autoimmune analysis is more reproducible and sensitive than traditional ELISA. There is a false positive for the hypersensitivity of the E601 HBeAb assay.