Vílchez Rodríguez Alberto, González Cantó Julia, Esteve Poblador Sara, Valldecabres Ortiz Carmen, Estela Burriel Pedro L
Area of Biological Diagnosis, La Ribera University Hospital, Alzira, Spain.
Adv Lab Med. 2020 Oct 29;1(4):20200096. doi: 10.1515/almed-2020-0096. eCollection 2020 Dec.
Clinical laboratories should use only validated procedures. Precision is an important factor in the validation and verification of a new measurement procedure. Our objective was to verify the precision and trueness of different analysers used for the biochemical and immunochemical characterization of analytes.
Advia 1800, Immulite2000 and CentaurXP analysers and the AtellicaSolution system were used. Five analytes were characterized biochemically, whereas another five analytes were characterized immunochemically. Imprecision was assessed using BioRad and Siemens control materials. Within-run and between-run imprecision were calculated by analysing three replicates of each control in a single run every day for five days. Bias was assessed using 40 samples of serum by the analysis of differences and linear regression.
The within-run and between-run imprecision values obtained with the new measurement procedure were lower than the ones claimed by the manufacturer for all the analytes studied. In the bias study, a proportional but not constant systematic error was observed in some analytes.
The coefficients of variation obtained with AtellicaSolution verified both, the imprecision specifications claimed by the manufacturer and by the laboratory. The conditions of calibration should be revised for some parameters and a wider range of samples should be used.
临床实验室应仅使用经过验证的程序。精密度是新测量程序验证和核查中的一个重要因素。我们的目的是验证用于分析物生化和免疫化学特性分析的不同分析仪的精密度和准确性。
使用了Advia 1800、Immulite2000和CentaurXP分析仪以及AtellicaSolution系统。对五种分析物进行生化特性分析，另外五种分析物进行免疫化学特性分析。使用BioRad和西门子对照材料评估不精密度。通过连续五天每天在一次运行中分析每个对照的三个重复样品来计算批内和批间不精密度。使用40份血清样本通过差异分析和线性回归评估偏倚。
对于所有研究的分析物，新测量程序获得的批内和批间不精密度值均低于制造商声称的值。在偏倚研究中，在一些分析物中观察到成比例但非恒定的系统误差。
AtellicaSolution获得的变异系数既验证了制造商声称的不精密度规格，也验证了实验室声称的不精密度规格。应针对某些参数修订校准条件，并应使用更广泛的样本。
