Laboratory Medicine, La Paz - Cantoblanco - Carlos III University Hospital, Madrid, Spain.
Spanish Society of Laboratory Medicine, Barcelona, Spain.
Clin Chem Lab Med. 2021 Oct 21;60(1):66-73. doi: 10.1515/cclm-2021-0786. Print 2022 Jan 26.
Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program.
The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant's accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups.
The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively.
Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories.
临床化学仪器中的血清指标被实验室广泛用于评估样本质量。能够报告定量结果的仪器可以以与其他生化测试类似的方式评估其诊断性能。西班牙临床实验室医学学会（SEQC-ML）于 2018 年启动了每月一次的血清指标外部质量计划，使用三种同时每年分配的冻干材料。我们呈现该计划头三年的结果。
使用四个不同浓度的不同质控材料，在三个交替月份中进行使用，允许参与者每年评估其准确性。赋值由具有相同条件的同类群组通过共识确定，至少需要 10 名参与者进行仪器级别的比较。每个仪器的平均百分比差异结果允许评估组间的偏差。
三个指标的不精密度在 3%到 9%之间，仪器之间没有明显差异。在超过 10 名参与者的所有仪器中，所有指标都观察到显著差异（罗氏 Cobas、雅培 Architect、雅培 Alinity 和西门子 Advia）。分布的百分比差异的第 90 个百分位数被用作分析性能规格（APS）。在计划的前三年，观察到性能有所提高，这可能是由于学习曲线效应。2020 年，建议分别将溶血、黄疸和脂血指数的 APS 设定为 7.8%、12.2%和 9.7%。
血清指标对实验室测试结果的质量和可靠性有重大影响。参加血清指标的能力验证计划有助于鼓励提供者和实验室之间的协调一致。
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