论文部分内容阅读
目的：了解ACCESS全自动微粒子化学发光免疫分析仪的主要物点及性能，对该仪器作了评价。方法：使用新鲜混合血清及质控品对分别用“三明治夹心”的促甲状腺素（TSH）、人绒毛膜慢性腺激素（β-HCG）、及“竞争抑制”的四碘甲状腺原氨酸（TT4）、三碘甲状腺原氨酸（TT3）酶免疫微粒子化学发光法检测项目，以双盲法作评价。结果：三种不同浓度新鲜混合血清的β-HCG、TSH、TT3、TT4批内精密度均小于5％；两个浓度批间精密度均小于6．5％；平均回收率TT3：102％，TT4：99％，TSH：98％；与过克法相比较TT3：r=0．94、TT4：r=0.93、TSH：r=0．95；β－HCG样本携带污染率为零。结论：仪器主要性能指标评价结果符合设计要求，ACCESS是具有优良性能的全自动免疫分析仪。
Objective: To understand the main points and performance of the ACCESS automated chemiluminescence immunoassay analyzer and evaluate the instrument. METHODS: The use of freshly-mixed serum and controls contained “sandwich sandwich” thyrotropin (TSH), human chorionic chronic chorionic hormone (β-HCG), and “competitive inhibition” of tetraiodothyronine ( The TT4) and Triiodothyronine (TT3) enzyme immunomicroparticle chemiluminescence assays were evaluated using the double-blind method. Results: The intra-assay precision of β-HCG, TSH, TT3 and TT4 in three different concentrations of fresh mixed serum was less than 5%; the inter-assay precision was less than 6.5% between two concentrations; the average recovery rate was TT3: 102%. TT4: 99%, TSH: 98%; TT3: r = 0.94, TT4: r = 0.93, TSH: r = 0.95 compared with super-grams; β-HCG samples carry zero contamination. Conclusion: The evaluation results of the instrument’s main performance indicators meet the design requirements. ACCESS is an automatic immunoanalyzer with excellent performance.