摘要
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 determination results of the Roche Cobus E601, the Abbott Architect i2000 automated immunoassay system and the Enzyme-Linked ImmunoSorbent Assay （ ELISA ） for hepatitis B virus markers. [ Methods ] 4 kinds of serum hepatitis B virus markers, including HBV surface antigen { HBsAg ）, anti-HBV surface antigen antibody （ HBsAb }, HBV e antigen （HBeAg） and anti-HBV e antigen antibody （HBeAb }, were tested by 3 methods synchronously in 761 samples of 4 batches （188, 215,178 and 180}. The samples were reexamined by real-time PCR, which showed significant difference in the HBeAg and HBsAg determination results among 3 methods. [ Results] Among 3 methods, the concordance rates of HBsAg （98.94%） was the highest, and that of HBeAg , HBsAb andHBe Ab was 94.94%, 90.70% and 83.3%, respectively. The Abbott Architect i2000 could be adopted for quantitative analysis on HBsAg and HBsAb, the Roche Cobus E601 only could be used for quantitative analysis on HB- sAb. The HBsAb quantitative results of i2000 and E601 had a good correlation. Among 4 kinds of serum hepatitis B virus markers, the concordance rate of determination results between E601 and i2000 was higher than that between ELISA and E601 （ or i2000 ） , and the positive rate of E601and i2000 was higher than ELISA. The positive rate of HBeAb determined by E601 was the highest {61.67% }. [ Conclusion] The quantitative measurement of HBsAg and HBsAb of automated immunity analyzers is unmatched by the traditional ELISA method for HBV replication and the effect of vaccination. The repeatability and sensitivity of automated analyzers is better than ELSA. But there is false positive results in HBeAb determination of E 601 with too high sensitivity.
出处
《职业与健康》
CAS
2010年第3期276-278,共3页
Occupation and Health
关键词
HBV的血清学标志物
全自动免疫分析仪
酶联免疫吸附测定
Serum hepatitis B virus markers
Automated immunoassay system
Enzyme-Linked Immuosorbent Assay { ELISA }
