Arias-Murillo Yazmin Rocio, Salinas-Nova María Angélica, Toloza-Pérez Yesith Guillermo, Castro-Jiménez Miguel Ángel
Grupo Red de Donación y Trasplantes, Instituto Nacional de Salud, Bogotá, D. C., Colombia.
Programa de Entrenamiento en Epidemiología de Campo - FETP, Instituto Nacional de Salud, Bogotá, D. C., Colombia.
Biomedica. 2024 Dec 23;44(Sp. 2):155-167. doi: 10.7705/biomedica.7589.
Introduction. The use of immunological tests before solid organ transplantation is essential to reduce the risk of rejection and post-transplant complications. Therefore, quality control systems in laboratories performing them are necessary for clinical practice. The Colombian Instituto Nacional de Salud implemented the external evaluation program of transplant immunogenetics laboratory performance in 2014. Objective. To evaluate the performance of the laboratories that carried out five of the immunological tests for transplants in Colombia between 2014 and 2023, according to information from the external evaluation program of transplant immunogenetics laboratory performance. Materials and methods. We conducted a study of laboratory performance considering five immunological tests for transplantation: HLA, qualitative and quantitative PRA (Panel Reactive Antibodies), isolated antigen, and cross-matching tests. We collected data from reports of each laboratory. Based on the comparisons between laboratories, their performance was rated as “good”, “acceptable”, or “unacceptable” for each test. We calculated proportions and an analysis of predicted values with a 95% confidence interval. Results. The number of participating laboratories varied between 5 and 12, depending on the test. The proportion of laboratories with “good” performance was lower in the first year. The best performance was for qualitative PRA, rated as good in all the laboratories for eight years. In HLA (2014), qualitative PRA (2017 and 2019), crossmatch tests (2019), and single antigen (2017 and 2019) tests, the laboratories had a lower percentage of “good” performance than expected. Conclusion. “Good” performance was observed in all the laboratories in each test during the last three years, except for HLA and quantitative PRA.
引言。在实体器官移植前进行免疫学检测对于降低排斥反应和移植后并发症的风险至关重要。因此，进行这些检测的实验室的质量控制系统对于临床实践是必要的。哥伦比亚国家卫生研究所于2014年实施了移植免疫遗传学实验室性能外部评估计划。
目的。根据移植免疫遗传学实验室性能外部评估计划的信息，评估2014年至2023年期间在哥伦比亚进行五项移植免疫学检测的实验室的性能。
材料和方法。我们对实验室性能进行了一项研究，考虑了五项移植免疫学检测：人类白细胞抗原（HLA）、定性和定量群体反应性抗体（PRA）、单一抗原检测以及交叉配型检测。我们从每个实验室的报告中收集数据。根据实验室之间的比较，对每项检测将其性能评为“良好”、“可接受”或“不可接受”。我们计算了比例并进行了95%置信区间的预测值分析。
结果。根据检测项目的不同，参与实验室的数量在5至12个之间变化。第一年表现为“良好”的实验室比例较低。定性PRA的表现最佳，在所有实验室中有八年被评为良好。在HLA检测（2014年）、定性PRA检测（2017年和2019年）、交叉配型检测（2019年）以及单一抗原检测（2017年和2019年）中，实验室“良好”表现的百分比低于预期。
结论。在过去三年中，除了HLA和定量PRA检测外，每项检测在所有实验室中均观察到了“良好”的表现。
