摘要
目的评价用Roche e601检测乙型肝炎病毒表面抗原的可行性。方法用Roche e601测定新鲜标本和HBsAg质控品,通过分析精密度、准确度、阴性和阳性符合率、检测低限、阴性标本可靠性等性能指标评价该检测系统测定HBsAg结果的可靠性。结果低、高值标本批内、批间精密度的变异系数(CV)均比厂家要求小;在60个室间质评样品检测结果中,HBsAg阴性符合率为100%(40/40)、阳性符合率100%(20/20);该系统的检测临界值为0.01IU/mL;40份HBsAg浓度在0.8<COI<1.0(接近临界值)且HBV-DNA检测结果均小于5.0×102的患者样本,用该检测系统检测结果均为阴性,阴性标本可靠性为100%。结论该检测系统检测乙型肝炎病毒表面抗原的性能能够满足临床要求。
Objective To evaluate the of feasibility of Roche e601 for detecting hepatitis B virus surface antigen（HBsAg）.Meth-ods To evaluate the feasibility of Roche e601 for detecting hepatitis B virus surface antigen（HBsAg）.Results The coefficient of variation（CV）of inter-run and between-run from low and high value specimens was lower than the requirements of manufacturers;the negative and positive coincidence rates in detecting 60 external quality assessment controls were 100%（40/40）and 100%（20 /20）,respectively;the detection threshold values of the system was 0.01 IU/mL;the results detected by this detecting system in 40 samples,in which the concentration of HBsAg was 0.〈COI〈1（close to the critical value）and the detection results of HBV-DNA were less than 5.0×10^2 ,were negative with the negative sample reliability of 100%.Conclusion The performance of this detection system for detecting HBsAg can meet the clinical requirements.
出处
《国际检验医学杂志》
CAS
2014年第16期2226-2227,共2页
International Journal of Laboratory Medicine
基金
广东省中医药局科研项目(20131203)
关键词
电化学发光免疫技术
乙型肝炎病毒表面抗原
检测系统
electrochemiluminescence immunoassay technology
hepatitis B surface antigens
detection system
