Bauça Josep Miquel, Caballero Andrea, Gómez Carolina, Martínez-Espartosa Débora, García Del Pino Isabel, Puente Juan José, Llopis Maria Antonia, Marzana Itziar, Segovia Marta, Ibarz Mercedes, Ventura Montserrat, Salas Paloma, Gómez-Rioja Rubén
Department of Laboratory Medicine, Hospital Universitari Son Espases Ctra, de Valldemossa, 79, J+1, 07120, Palma, Illes Balears, Spain.
Commission on Extraanalytical Quality, SEQC-ML, Spain.
Adv Lab Med. 2020 Apr 21;1(2):20200021. doi: 10.1515/almed-2020-0021. eCollection 2020 Jun.
The stability of the analytes most commonly used in routine clinical practice has been the subject of intensive research, with varying and even conflicting results. Such is the case of alanine aminotransferase (ALT). The purpose of this study was to determine the stability of serum ALT according to different variables.
A multicentric study was conducted in eight laboratories using serum samples with known initial catalytic concentrations of ALT within four different ranges, namely: <50 U/L (<0.83 μkat/L), 50-200 U/L (0.83-3.33 μkat/L), 200-400 U/L (3.33-6.67 μkat/L) and >400 U/L (>6.67 μkat/L). Samples were stored for seven days at two different temperatures using four experimental models and four laboratory analytical platforms. The respective stability equations were calculated by linear regression. A multivariate model was used to assess the influence of different variables.
Catalytic concentrations of ALT decreased gradually over time. Temperature (-4%/day at room temperature vs. -1%/day under refrigeration) and the analytical platform had a significant impact, with Architect (Abbott) showing the greatest instability. Initial catalytic concentrations of ALT only had a slight impact on stability, whereas the experimental model had no impact at all.
The constant decrease in serum ALT is reduced when refrigerated. Scarcely studied variables were found to have a significant impact on ALT stability. This observation, added to a considerable inter-individual variability, makes larger studies necessary for the definition of stability equations.
常规临床实践中最常用分析物的稳定性一直是深入研究的主题,结果各不相同,甚至相互矛盾。丙氨酸氨基转移酶(ALT)就是这样的情况。本研究的目的是根据不同变量确定血清ALT的稳定性。
在八个实验室进行了一项多中心研究,使用血清样本,其ALT的初始催化浓度在四个不同范围内,即:<50 U/L(<0.83 μkat/L)、50 - 200 U/L(0.83 - 3.33 μkat/L)、200 - 400 U/L(3.33 - 6.67 μkat/L)和>400 U/L(>6.67 μkat/L)。使用四种实验模型和四个实验室分析平台在两个不同温度下将样本储存七天。通过线性回归计算各自的稳定性方程。使用多变量模型评估不同变量的影响。
ALT的催化浓度随时间逐渐降低。温度(室温下每天降低4%,冷藏下每天降低1%)和分析平台有显著影响,Architect(雅培)表现出最大的不稳定性。ALT的初始催化浓度对稳定性只有轻微影响,而实验模型根本没有影响。
冷藏时血清ALT的持续降低幅度减小。发现很少研究的变量对ALT稳定性有显著影响。这一观察结果,再加上个体间相当大的变异性,使得有必要进行更大规模的研究来定义稳定性方程。