摘要
目的:评价AutolumiS3000型微粒子化学发光分析仪的检测性能。方法:收集125例患者的125份血清检测标本,对Autolumi S3000的定量检测项目乙肝表面抗原(HBs Ag)的精密度、线性范围、符合率以及携带污染率进行性能评价,以雅培i2000型全自动化学分析仪检测HBs Ag的结果为对照,评价AutolumiS3000型微粒子化学发光分析仪检测HBsAg的性能。结果:AutolumiS3000检测HBsAg的批内精密度、批间精密度均<10%;线性验证实验中,回归方程为y=1.0091X-0.8472,相关系数r2=0.9975,且相关性良好;符合率以雅培i2000的HBsAg检测结果为对照,该仪器临床检测阳性值符合率为97%,阴性值符合率为100%,总符合率为98.4%,携带污染率为0.006%,各项均符合AutolumiS3000型微粒子化学发光分析仪的性能要求。结论:AutolumiS3000型微粒子化学分析仪性能良好,用于HBsAg的检测可满足一般临床实验室检测要求。
Objective: To evaluate the analytical performance of AutolumiS3000 micro-particle chemiluminescent analyzer. Methods: 125 serum samples of 125 patients were collected, and the precision, linear range, coincidence rate and carrying contamination rate were used to implement performance evaluation for AutolumiS3000 in detecting HBsAg. The results of HBsAg that were detected by Abbott i2000 full-automatic chemistry analyzer were used as comparisons to evaluate the performances of AutolumiS3000 micro-particle chemiluminescent analyzer in detecting HBsAg. Results: Both the intra-batch and inter-batch precision of AutolumiS3000 in detecting HBsAg were less than 10%, respectively. In the verification of linear experiment, the regression equation was y=1.0091 X-0.8472, and the correlation coefficient was(r2=0.9975), and the correlation was good. The results of Abbott i2000 full-automatic chemistry analyzer in detecting HBsAg was used as comparisons, and the coincidence rates of the positive value and the negative value and the total coincidence rate of this instrument were 97%, 100% and 98.4% respectively. And the carrying pollution rate was 0.006%. All of above indicators met the performance requirements of AutolumiS 3000 micro-particle chemiluminescence analyzer. Conclusion: AutolumiS3000 micro-particle chemiluminescence analyzer has good performance and can meet the testing requirements of general clinical laboratory for HBsAg.
作者
邵淑丽
丛海燕
曲业敏
耿建利
孙胜波
王明义
SHAO Shu-li;CONG Hai-yan;QU Ye-min(Central Laboratory,Weihai Municipal Hospital Affiliated to Dalian Medical University,Weihai 264200,China)
出处
《中国医学装备》
2019年第8期24-26,共3页
China Medical Equipment
