【摘要】 目的 通过对HBsAg低值血清样本的检测,评价ELISA方法的检测性能。方法 收集化学发光法(CMIA)检测结果为0.05~9.99IU/ml的HBsAg低值血清样本305份,采用ELISA方法进行复孔检测。结果 HBsAg低值样本占HBsAg阳性样本的18.12%,主要分布于中老年人群。ELISA方法的总检出率为87.87%,其中0.05~0.11,0.12~0.20,0.21~0.50,0.51~1.00,1.01~5.00 IU/ml和5.01~9.99 IU/ml水平的检出率分别为36.00%,61.11%,78.38%,84.62%,99.11%和100.00%,各水平检出率之间差异有明显统计学意义(χ~2=99.84,P=0.000)。ELISA方法检测HBsAg低值样本的S/CO结果与CMIA方法检测结果存在较高的相关性(r=0.874,P=0.000)。结论 ELISA方法检测HbsAg低值血清存在漏检的情况,临床实验室应根据实验目的 合理选择实验方法。更多还原

【Abstract】 Objective To evaluate the performance of ELISA by detecting low quantitative HBsAg in serums.Methods 305 serum samples that the quantitation range was from 0.05 IU/ml to 9.99 IU/ml were collected,and then detected by ELISA.Results The rate of patients with low quantitation of HBsAg was 18.12%in patients with positive HBsAg.The total detected rate of ELISA was 87.87%,and the rate of 0.05 ~ 0.11,0.12 ~ 0.20,0.21~0.50,0.51 ~ 1.00,1.01~5.00 IU/ml and 5.01 ~ 9.99IU/ml were 36.00%,61.11%,78.38%,84.62%,99.11%and 100.00%.respectively.The differences were statistically significant between the detected rates of each group(χ~2 =99.84,P = 0.000).There was high correlation coefficient between the results detected by ELISA and by CMIA(r= 0.874,P = 0.000).Conclusion The clinical laboratory should be careful to apply the method of ELISA to detect HBsAg for its missing detection in samples with low quantitation of HBsAg.更多还原