Costongs G M, van Oers R J, Leerkes B, Janson P C
Maaslandziekenhuis, Sittard, The Netherlands.
Eur J Clin Chem Clin Biochem. 1995 Nov;33(11):887-92.
The automated immunoassay analyser, IMMULITE, developed by DPC, was evaluated. IMMULITE is an automated system that allows random access in combination with immediate and continuous access. In this study we evaluated the IMMULITE on four panels of analytes: thyroid, fertility, tumour and "non-routine" markers. We observed good within-rum reproducibility (ranging from 2.3-15.9% CV, for low controls, to 2.7-8.7% CV for high controls) as well as between-day imprecision (ranging from 3.7-24.6% CV for low controls, to 2.5-11.8% cv for high controls). The analytical sensitivity of the assays ranged generally from very sensitive to acceptable. The dilution curves for all assays were nearly linear i.e. the maximum deviation of the observed from the expected recovery was 8%. Correlation between IMMULITE and other assays (AxSYM, IMx, TDx, AIA-1200, DPC-c. a. c., Medgenix) varied from r = 0.931 to r = 0.994, except for lutropin and parathyrin with coefficients of correlation of r = 0.594 and r = 0.591. The slopes of the regression lines ranged from 0.745 to 1.327, except for parathyrin where a slope of 2.389 was found. Inter-laboratory correlation was very good between the two locations (Sittard and Apeldoorn) and varied from r = 0.984 to r = 0.999; slopes of the regression lines varied from 0.924 to 1.086. We conclude that the DPC-IMMULITE system is suitable for testing routine analytes in random access mode as well as for testing "non-routine" analytes on an automated immunoassay analyser.
对DPC公司研发的自动免疫分析仪器IMMULITE进行了评估。IMMULITE是一个自动化系统,支持随机检测,同时兼具即时和连续检测功能。在本研究中,我们针对四组分析物对IMMULITE进行了评估:甲状腺标志物、生育相关标志物、肿瘤标志物和“非常规”标志物。我们观察到其批内重复性良好(低浓度质控品的变异系数范围为2.3% - 15.9%CV,高浓度质控品为2.7% - 8.7%CV),日间不精密度也较好(低浓度质控品的变异系数范围为3.7% - 24.6%CV,高浓度质控品为2.5% - 11.8%CV)。各检测项目的分析灵敏度总体上从非常灵敏到可接受。所有检测项目的稀释曲线几乎呈线性,即观察到的回收率与预期回收率的最大偏差为8%。IMMULITE与其他检测方法(AxSYM、IMx、TDx、AIA - 1200、DPC - c.a.c.、Medgenix)之间的相关性在r = 0.931至r = 0.994之间变化,但促黄体生成素和甲状旁腺素除外,其相关系数分别为r = 0.594和r = 0.591。回归线的斜率范围为0.745至1.327,但甲状旁腺素的斜率为2.389。两个地点(锡塔德和阿珀尔多伦)之间的实验室间相关性非常好,r值在0.984至0.999之间;回归线的斜率在0.924至1.086之间。我们得出结论,DPC - IMMULITE系统适用于以随机检测模式检测常规分析物,也适用于在自动免疫分析仪器上检测“非常规”分析物。