摘要
目的了解乙型肝炎DICA法和ELISA法试剂盒检测血清标志物HBsAg、抗-HBs的检出限,降低假阴性风险。方法使用生理盐水将定值质控血清按照1∶2、1∶4、1∶8、1∶16、1∶32、1∶64、1∶128、1∶256的比例进行倍比稀释,然后用3个厂家的DICA试剂盒和2个厂家的ELISA试剂盒检测不同浓度的血清,记录结果。结果①HBsAg检出限:3个厂家DICA试剂中,1个为4 IU/mL,另外2个均为1 IU/mL;2个厂家ELISA试剂均为0.25 IU/mL。②抗-HBs检出限:3个厂家DICA试剂均为30 mIU/mL;2个厂家ELISA试剂中1个为15 mIU/mL,另1个为7.5 mIU/mL。③ELISA法检测HBsAg、抗-HBs的检出限均优于DICA法,约需DICA法检出限的1/4即可检出。④在具体项目上,同方法不同厂家的试剂盒检出限存在不同程度的差异,而DICA法尤为明显。结论同方法不同厂家试剂检出限可能存在明显差异,宜在使用前进行质量评价,降低假阴性风险。ELISA法检测HBsAg、抗-HBs的检出限均优于DICA法,但简便性不及DICA法,可根据实际需求选择检测方法。
Objective To investigate the detection limit of Hepatitis B serum markers HBsAg and HBsAb by DICA(dot immunogold chromatographic assay) and ELISA kits, and to reduce the risk of false negative. Methods Normal saline was used to dilute the quality control serum according to the proportion of 1∶2, 1∶4, 1∶8, 1∶16, 1∶32, 1∶64, 1∶128, and 1∶256, and then different concentrations of serum were detected with DICA kits of 3 manufacturers and ELISA kits of 2 manufacturers. Results 1. HBsAg detection limit: the results by DICA assay showed that the detection limit by one kit was 4 IU/mL, and the other two were 1 IU/mL, while the two ELISA kits both recorded a detection limit of 0.25 IU/mL;2. Anti-HBs detection limit: all DICA kits were 30 mIU/mL, while in the two ELISA kits, one was 15 mIU/mL and another one was 7.5 mIU/mL;3. The ELISA method had better detection limit than the DICA method did, with the detection limit being 1/4 of that by DICA;4. In a specific project, the same method with test kits of different manufacturers had different detection limits, especially by DICA method. Conclusion 1. The detection limit of the same method with kits from different manufacturers was obviously different. It is appropriate to evaluate the quality before use to reduce the risk of false negative. 2. The detection limit of ELISA test of HBsAg and anti-HBs was better than DICA test, but it was not as convenient as DICA test. It is practical to choose a test method according to actual demand.
作者
罗伟
LUO Wei(Hubei Provincial Center for Disease Control and Prevention,Wuhan 430079,China)
出处
《公共卫生与预防医学》
2019年第6期26-28,共3页
Journal of Public Health and Preventive Medicine
关键词
乙型肝炎
检出限
假阴性
检测
Hepatitis B
Detection limit
False negative
Test
