摘要
目的按美国病理学家协会CAP和ISO15189实验室认可的要求,对罗氏Elecsys MODULAR AN-ALYTICS E-170电化学发光系统乙型肝炎表面抗原(HBsAg)定量检测进行方法学评价和性能验证。方法取患者高、低值混合血清,分别进行批内20次和连续20d检测,计算批内不精密度和批间不精密度;将高、低值血清按一定比例混合后进行检测,验证分析测量范围(AMR);取浓度接近1∶400稀释检测低限值的血清标本,连续检测12d,进行可报告低限值(LoQ)验证;取原倍及自动稀释后均可检测的标本,进行原倍及自动稀释检测,计算其符合程度,进行自动稀释正确度验证。结果高、低值批内不精密度(以变异系数表示)分别为2.23%和1.99%,批间不精密度分别为4.03%和3.16%,LoQ为24.905IU/mL,AMR为22.075～48 158.25IU/mL;自动稀释与原倍检测结果偏差小于20%。结论该系统检测性能符合实验室质量要求。
Objective To evaluate the method for hepatitis B surface antigen（HBsAg） detection with Roche electrochemiluminescence system.Methods The within-run and between-day imprecision was evaluated with high and low level mixed serum.The analytic mesurea range（AMR） was evaluated with serially diluted serums.Limit of quanlity（LoQ） was evaluated with continous detection of low level serums.Accuracy of auto-dilution was evaluated with primary serum sample and diluted samples.Results The imprecision for high and low value were 2.23% and 1.99% for within-run and were 4.03% and 3.16% for between-day.The LoQ was 24.905 IU/mL and the AMR was 22.075-48 158.25 IU/mL.The bias between primary and diluted samples was less than 20%.Conclusion The system measurement characteristic fit the requirement of clinical laboratory.
出处
《检验医学与临床》
CAS
2013年第11期1407-1408,共2页
Laboratory Medicine and Clinic
