Ten years of the immunogenetics laboratory performance assessment programme and its impact on the donor and transplant network

Abstract

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.