摘要
目的:比较2种不同孵育时间的检测乙型肝炎病毒表面抗原(HBsAg)的酶联免疫吸附试验(ELISA)试剂盒的性能差异。方法:使用同一厂商生产的2种不同孵育时间(30min和60min)的HBsAgELISA试剂盒同时检测血清样本,比较2种试剂盒的检测精度、抗干扰能力和检测结果的一致性。结果:2种试剂盒的检测精度没有统计学差异,批内变异系数(CV)均小于10%,批间CV均小于15%;血红蛋白<4.0g/L、三酰甘油<2.2mmol/L、胆红素<260μmol/L对2种试剂均不产生影响。2种试剂平行检测229份样本,其中有33例样本检测结果不一致,进一步用电化学发光法全自动检测系统复检,结果均为弱反应性样本。结论:2种试剂盒的检测精度和抗干扰能力无差异,但60min孵育试剂盒对于HBsAg弱反应性样本的检出率明显高于30min孵育试剂盒。
Objective To compare the performance characteristics of two kinds of HBsAg ELISA kits with different incubation time （30 min and 60 min）. Methods Used two kinds of HBsAg ELISA kit with different incubation time produced by same manufacturer to test same lots of blood sample. Their performance characteristics including precision,interference resistance,and result agreement were compared between these two kinds of kit. Results No significant difference was noted in precision between these two kinds of kit.Coefficient of variation （CV） within-run was within 10% and between-run was within 15%;hemoglobin 〈4.0 g/L,triglyeride〈2.2 mmol/L,and bilirubin 〈260 μmol/L would not interfere the test results. Two hundreds and twenty-nine blood samples underwent parallel test by these two kits; discrepant results were seen in 33 samples and ECLIA showed all were weakly reactive samples. Conclusions No significant difference is seen in precision and interference resistance between these two kinds of kit,however,the 60 minutes incubation time kit had higher detection rate in weakly reactive samples.
出处
《诊断学理论与实践》
2010年第2期186-189,共4页
Journal of Diagnostics Concepts & Practice
关键词
乙型肝炎病毒表面抗原
酶联免疫吸附试验
精密度
抗干扰
Hepatitis B surface antigen
Enzyme linked immunosorbent assay
Precision
Interference resistance
