摘要
目的：按IS015189要求验证雅培i2000化学发光检测TPSA分析性能。方法：对总前列腺特异性抗原（TPSA）精密度、正确度、线性范围、自动稀释倍数、功能灵敏度和参考区间进行验证。结果：批内或批间变异系数（CV）不仅小于卫生部室间质评标准精密度参数，也小于厂家提供准精密度参数；对配套定值血清测定值与靶值之间的偏差小于允许偏差；线性范围与厂家提供范围一致；自动稀释倍数偏差符合临床检测要求；功能灵敏度和参考区间验证通过。结论：检测系统的基本性能达到临床化学检验领域的要求，也符合肿瘤标志物临床应用指导原则的要求。可将经过评价的检测系统用于常规工作。
Objective To verify the performance of Abbott i2000 chemiluminescence in the detection of TPSA according to the requirement of IS015189. Methods The precision, accuracy, automatic dilution, linear range, functional sensitivity and reference interval of total prostate specific antigen （TPSA） were validated. Results The intra or inter assay coefficient of variation （CV） is not only less than standard precision parameters on quality assessment of health department, but also less than manufacturers provided accurate density parameter;The deviation value between serum measured value and the target value is less than the allowable devia-tion;Linear range is consistent with that provided by the manufacturers;Automatic dilution bias is also consistent with clinical testing requirements;functional sensitivity and reference interval validation passed. Conclusion The basic performance of the detection sys-tem can meet the requirements of clinical chemistry examination, and also meet the requirements of clinical application of tumor markers. The evaluation system can be used for routine work.
出处
《医学检验与临床》
2016年第5期31-34,共4页
Medical Laboratory Science and Clinics
