Alsius-Serra A, Ballbé-Anglada M, López-Yeste M L, Buxeda-Figuerola M, Guillén-Campuzano E, Juan-Pereira L, Colomé-Mallolas C, Caballé-Martín I
Bioquímica Catlab.
Calidad Catlab.
Rev Calid Asist. 2015 Nov-Dec;30(6):281-8. doi: 10.1016/j.cali.2015.08.003. Epub 2015 Nov 3.
To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories.
Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots.
The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers.
The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error.
描述对卡特实验室4个实验室中生物化学处理的生物检测测量水平可比性的研究。
确定质量要求、变异系数和总误差（CV%和TE%）。对照在每个检测项目和每个独立实验室分析仪中按照精密度要求（CV%）进行验证。新鲜血清样本用于可比性研究。使用Microsoft Access®应用程序分析差异，该程序生成改良的布兰德-奥特曼图。
对在多个实验室和/或分析仪中进行的32项生物参数的比较生成了306张布兰德-奥特曼图。其中，101张（33.1%）落在基于生物变异性的可接受值范围内，205张（66.9%）需要修订。根据分析质量的共识最低规范（西班牙药物分析师协会（AEFA）、西班牙临床生物化学与分子病理学协会（SEQC）、西班牙医学活检协会（AEBM）和西班牙血液学与血液疗法协会（SEHH）的共识，2013年10月）对数据进行重新分析。根据新规范，170项比较（56%）符合要求，136项（44%）需要进一步审查。考虑到超出要求的点数、随机误差、检测到差异的结果范围以及临床决策范围，结果表明需要审查的44%是可以接受的，并且这32项检测在所有实验室和分析仪中具有可比性。
结果分析表明符合4个科学协会的共识要求。然而，每个实验室应旨在满足更严格的总误差标准。
