CAJ | 학술논문

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（χ2＝99.84，P ＝0.000）。ELISA 方法检测 HB-sAg 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。
목적：통과대 HBsAg 저치혈청양본적검측，평개 ELISA 방법적검측성능。방법수집화학발광법（CMIA）검측결과위0.05～9.99IU／ml 적 HBsAg 저치혈청양본305빈，채용 ELISA 방법진행복공검측。결과 HBsAg 저치양본점HBsAg 양성양본적18.12％，주요분포우중노년인군。ELISA 방법적총검출솔위87.87％，기중0.05～0.11，0.12～0.20，0.21～0.50，0.51～1.00，1.01～5.00 IU／ml 화5.01～9.99 IU／ml 수평적검출솔분별위36.00％，61.11％，78.38％，84.62％，99.11％화100.00％，각수평검출솔지간차이유명현통계학의의（χ2＝99.84，P ＝0.000）。ELISA 방법검측 HB-sAg 저치양본적 S／CO 결과여 CMIA 방법검측결과존재교고적상관성（r ＝0.874，P ＝0.000）。결론ELISA 방법검측HbsAg 저치혈청존재루검적정황，림상실험실응근거실험목적합리선택실험방법。
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 de-tected 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(χ2 =99.84,P =0.000).There was high correlation coeffi-cient 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.