低水平HBsAg 3种方法检测结果比较

目的探讨同一公司国产一步法和二步法酶联免疫吸附试验(ELISA)乙型肝炎表面抗原(HBsAg)试剂的敏感性。方法使用同一公司国产一步法和二步法ELISA试剂检测HBsAg,并与化学发光微粒子免疫分析(CMIA)法检测结果进行对比。结果 90例CMIA法检测结果为阴性的样本,一步法和二步法ELISA检测HB-sAg结果均为阴性;61例CMIA法检测结果为低水平HBsAg样本,一步法ELISA检测阳性15例,二步法ELISA检测阳性46例,二步法ELISA HBsAg试剂比一步法ELISA敏感性明显提高(P<0.01);一步法ELISA在CMIA法检测数值在2.50U/mL以上的检出率与CMIA法保持一致;二步法ELISA在CMIA法检测数值在0.50U/mL以上的检出率与CMIA法保持一致;二步法ELISA检出率在CMIA法检测数值小于或等于0.50U/mL时明显低于CMIA法(P<0.01)。结论二步法ELISA试剂比一步法ELISA试剂检测HBsAg的敏感性明显提高,但在低水平HBsAg检测时敏感性低于CMIA法。

Comparative study about CMIA and two kinds of ELISA on low level of HBsAg samples

Objective To compare the sensitivity between China-made one-step hepatitis B surface antigen （HBsAg） enzyme linked immunosorbent assay （ELISA） reagent and two-step HBsAg ELISA reagent supplied by same company. Methods HBsAg samples were detected by one-step ELISA and two-step ELISA,at the same time compared with the result tested by CMIA. Results In 90 cases,the results of one-step ELISA and two-step ELISA were all negative while CMIA were negative. Among 61 low level samples detected by CMIA, 15 positive samples were detected by one-step ELISA,46 positive samples were detected by two-step ELISA. The sensitivity of two-step ELISA was significantly higher than that of one-step ELISA（P〈0.01）. One-step ELISA had the same sensitivity of detection with CMIA above 2.50 U/mL. Two-step ELISA had the same sensitivity of detection with CMIA above 0.50 U/mL. The sensitivity of two-step ELISA was significantly lower than CMIA under 0. 50 U/mL（P〈0.01）. Conclusion The sensitivity of two-step ELISA is significantly higher than one-step ELISA, but is still less than CMIA in the lower level samples.