Abstract

Transition to new analytical systems and methods requires end-user verification to ensure acceptability for routine use. Our aim was to verify precision of MAGLUMI 800 immunoassay analyzer for 17-hydroxyprogesterone (17-OHP), 25-hydroxy vitamin D (25(OH)D), aldosterone, androstenedione, growth hormone (GH), insulin-like growth factor 1 (IGF-1), insulin-like growth factor-binding protein 3 (IGFBP-3) and renin, as well as to assess their comparability with the routinely used assays. Precision was evaluated at two levels following the CLSI EP15-A2 protocol. Method comparison included parallel analysis of 40 routine samples for each assay on MAGLUMI 800 and the routinely used automated or manual immunoassays. Within-run coefficients of variation (CV) ranged from 0.8% (androstenedione) to 14.5% (aldosterone), between-run CVs from 1.0% (IGFBP-3) to 12.8% (renin), while within-laboratory (total) precision CVs were from 2.1% (IGFBP-3) to 14.9% (renin). All assays with the exception of IGF-1 and 25(OH)D at the low concentration control level, satisfied biological variation criteria for imprecision. Passing-Bablok regression showed proportional difference for 17-OHP and aldosterone, constant for androstenedione, while both constant and proportional difference was revealed for 25(OH)D, GH and IGF-1. Statistically significant relative biases higher than the desirable biological variation acceptance criteria were observed for 17-OHP, 25(OH)D, aldosterone, androstenedione and IGF-1. The evaluated assays need further assessment as well as verification of reference intervals in order to be suitable for introduction into routine practice in our laboratory. Our study clearly demonstrates that we are still far from achieving immunoassay standardization and comparability of results.

摘要

过渡到新的分析系统和方法需要最终用户验证，以确保常规使用的可接受性。我们的目的是验证 MAGLUMI 800 免疫分析仪对 17-羟基孕酮 (17-OHP)、25-羟基维生素 D (25(OH)D)、醛固酮、雄烯二酮、生长激素 (GH)、胰岛素样生长因子 1 的精确度(IGF-1)、胰岛素样生长因子结合蛋白 3 (IGFBP-3) 和肾素，以及评估它们与常规检测方法的可比性。遵循 CLSI EP15-A2 协议，在两个级别上评估了精度。方法比较包括在 MAGLUMI 800 和常规使用的自动或手动免疫测定法上对 40 个常规样品进行平行分析。运行内变异系数 (CV) 范围从 0.8%（雄烯二酮）到 14.5%（醛固酮），运行间变异系数从 1.0% (IGFBP-3) 到 12。8%（肾素），而实验室内（总）精密 CV 从 2.1%（IGFBP-3）到 14.9%（肾素）。除低浓度对照水平的 IGF-1 和 25(OH)D 外，所有测定均满足不精密度的生物学变异标准。Passing-Bablok 回归显示 17-OHP 和醛固酮的比例差异，雄烯二酮恒定，而 25(OH)D、GH 和 IGF-1 的恒定和比例差异。对于 17-OHP、25(OH)D、醛固酮、雄烯二酮和 IGF-1，观察到高于理想生物变异接受标准的统计学显着相对偏差。评估的化验需要进一步评估和验证参考区间，以便适合引入我们实验室的常规实践。