ELISA与ECLIA对HBsAg弱反应性标本检测的比较

目的比较酶联免疫吸附试验（ELISA）和电化学发光（ECLIA）检测乙型肝炎表面抗原（HBsAg）弱反应性标本的结果。方法将由酶联免疫法（ELISA）检测的HBsAg结果（S/CO）在0.7～5.0之间的824份弱反应性血清标本进行电化学发光（ECLIA）测定。结果①352例S/CO在0.7～0.99区间,即ELISA定性为阴性,ECLIA检测结果有48例COI≥1.0（阳性）,差异有统计学意义（P〈0.05）;②432例S/CO在1.0～LPC（弱阳性质控）,即ELISA定性为阳性,ECLIA检测结果有248例COI（cutoff指数）〈1.0（阴性）,差异有显著统计学意义（P〈0.01）;③40例S/CO在LPC～5.0,即ELISA定性为阳性,ECLIA检测结果COI≥1.0（阳性）。结论 S/CO在0.7～0.99的标本,ECLIA灵敏度优于ELISA;S/CO在1.0～LPC的标本,ELISA的影响因素较多,容易造成假阳性结果,应分析原因并进一步复查;S/CO在LPC～5.0的标本,ELISA和ECLIA方法均能准确地判断。

Comparison of ELISA and ECLIA in Testing HBsAg Weak Reactive Samples

Objective To compare the results of enzyme linked immunosorbent assay （ELISA） and electrochemiluminescence immunoassay （ECLIA） in testing HBsAg weak reactive samples. Methods 824 HBsAg weak reactive serum samples, which had been tested by ELISA and their S/CO were 0.7 ~ 5.0, were re-tested by the ECLIA. Results ①352 serum samples＇ S/CO were 0.7 ~ 0.99, the qualitation was negative by ELISA, but COI≥1.0 in 48 samples by ECLIA （positive）, there were significant differences （P 0.05）; ②432 serum samples＇ S/CO were 1.0 ~ LPC （the QC of the weak positive）, the qualitation was positive by ELISA, but COI1.0 in 248 samples by ECLIA （negative）, there were statistically significant differences （P 0.01）; ③40 serum samples＇ S/CO were LPC ~ 5.0, the qualitation was positive by ELISA, and COI≥1.0 in all 5 samples by ECLIA （positive）. Conclusion In the cases of 0.7S/CO0.99, ECLIA is better than ELISA in the sensitiveness; when S/CO are 1.0 ~ LPC, ELISA is effected by many factors, so it easily leads to false positive results and we shall analyze the reasons and further review; when S/CO are LPC ~ 5.0, both methods can accurately determine.