2种方法检测乙型肝炎表面抗原的比较

Comparison of two methods of detecting serum hepatitis B surface antigen

目的:比较金标法(GICA)与酶联免疫吸附法(ELISA)检测乙型肝炎表面抗原(HBsAg)的结果。方法:对5 632份血清标本同时采用GICA和ELISA检测HBsAg,以ELISA为标准,对GICA的灵敏度、特异性进行评价。结果:5 632份血清中以ELISA为标准,HBsAg阳性507例,阳性率为9.00%;GICA有34份假阴性,31份假阳性,灵敏度为93.84%,特异性为99.34%。34例假阴性中HBsAg均为弱阳性OD/CO值在1.50～4.76。2种方法测定的HBsAg结果差异无统计学意义(P>0.05),且具有高度一致性(Kappa=0.929 4,P<0.01)。结论:GICA适用于单份检测,无需任何仪器,且快速简便,但灵敏度、特异性稍差,特别是针对HBsAg弱阳性有漏诊可能;ELISA虽然步骤多,时间长,但灵敏度高,特异性强,适合批量检测。实验室应根据实际需要结合工作情况选用。

Objective：To compare the detecting hepatitis B surface antigen （HBsAg） results by GICA and ELISA. Methods：The serum HBsAg of 5 632 cases were detected by GICA and ELISA methods, the sensitivity and specificity of GICA was evaluated according to ELISA standard. Results： Based on ELISA standard, HBsAg positive of 507 cases were detected, and the positive rate was 9.00% by GICA. The false negative of 34 cases and false positive of 31 cases were found, and the sensitivity and specificity were 93.84% and 99.34% respectively. The vlaues of OD/OC of the false negative of 34 cases with weakly positive of HBsAg were 1.50 to 4.76. The HBsAg results of two methods had no significant difference （P 〉 0.05 ）, and a high degree of consistency（ Kappa = 0.929 4, P 〈 0.01 ）. Conclusions： GICA method can be a single detection, which is simple and rapid way without any equipment, but its sensitivity and specificity are poor, and may have miss diagnosis especially for HBsAg of weakly positive. The ELISA with multiple steps, long time, high sensitivity and strong specificity can detect a large number samples, which can be applied according to work needs.