LUMO化学发光免疫分析系统测量性能的初步评价

目的对LUMO半自动化学发光免疫分析系统的测量性能作出初步评价。方法依照《临床实验室定量方法的初步评价-标准指南》（第2版）EP10-A2实验方案，每天用高（37．50pmol／L）、中（19．63pmol／L）、低（1．75pmol／L）3种浓度水平的标准品作为测量样本进行血清游离三碘甲状腺原氨酸（FT3）检测，计算FT3的偏倚、总不精密度、斜率、携带污染率、非线性、漂移。并进行t检验。结果高、中、低值的偏倚分别为0．14、2．40、3．77pmol／L；总不精密度分别为：9．29％、6．29％、4．83％；非线性：-0．0013；携带污染率：-1．0494％；漂移：-0．0084；斜率：1．1032；截距：0．099。结论LUMO半自动化学发光仪FT3测定的偏倚、总不精密度均在允许范围内。在验证范围内有良好的线性关系，携带污染率较低，漂移稳定性较好，各项评价指标基本能够满足临床要求。

Valuation of the performance of LUMO chemiluminescence immunoassay system of preliminary assessment

Objective Using EP10-A2 to make a preliminary evaluation of LUMO semiautomatic chemiluminescence＇s detection performance. Methods With high（37.5pmol/） ,medium（19. 625pmol/L） and low（1.75pmol/L） concentrations of three samples which are made in different manufacturers, the concentration of their FT3 contents were measured, and the deviation of FT3, total nonprecision, the slope, carrying pollution rate, nonlinearity and drift were calculated,And T test was conducted at the same time. Results The high value, medium value and low value deviations are 0. 14pmol/L,2.4pmol/L, 3. 77pmol/L respectively; the total nonpreeision is 9. 29 %,6.29%, 4.83% respectively; Nonlinear is 1. 2009; carryover rate is 1. 0494% ; drift is 0. 0084; slope is 1. 1032 and the intercept is 0. 099. Conclusion The deviation and the total nonprecision determined by FT3＇s concentration of LUMO semiautomatic chemiluminescence were all permitted. To a certain degree, it has a good linear relationship, a lower pollution rate for carrying-over and a relatively good stability. All indicators can meet the clinical requirements.