Abstract:
ABO blood group antigens are critical determinants of immunologic self and non-self and are ubiquitously expressed on all cellular tissues. Antibodies against non-self ABO antigens are naturally present and can mediate pathologic reactions against incompatible transfused blood cells and transplanted tissues. Laboratory testing for ABO antigens and isoagglutinins is essential for safe and effective transfusion and transplantation. Testing for ABO antigens has traditionally depended on serologic testing. However, there is increasing need for evaluation of genetic analysis of ABO antigens, to enable evaluation of ABO blood group in cases where serologic testing may be ambiguous or impossible to accurately perform. The clinical need for ABO genotyping is being addressed by the development of multiple molecular diagnostic approaches. Recent data have clearly demonstrated the potential utility of ABO genotyping in solid organ transplantation, yet widespread implementation has been slow. We propose that this lag is related to practical considerations in laboratory testing, including limited regulatory guidance on the performance and reporting of these assays and the absence of widely available external proficiency testing programs for quality assurance. Here we describe approaches to ABO genotyping, current initiatives in developing ABO genotyping proficiency testing programs, and laboratory quality assurance considerations for ABO genotyping.
摘要:
ABO血型抗原是免疫自身和非自身的关键决定因素,并在所有细胞组织中普遍表达。针对非自身ABO抗原的抗体是天然存在的,并且可以介导针对不相容的输血血细胞和移植组织的病理反应。ABO抗原和等凝集素的实验室测试对于安全有效的输血和移植至关重要。传统上,ABO抗原的测试取决于血清学测试。然而,越来越需要评估ABO抗原的遗传分析,在血清学检测可能不明确或无法准确进行的情况下,能够评估ABO血型。ABO基因分型的临床需求正通过多种分子诊断方法的发展来解决。最近的数据清楚地证明了ABO基因分型在实体器官移植中的潜在效用。然而,广泛的实施进展缓慢。我们建议这种滞后与实验室测试中的实际考虑有关,包括对这些分析的性能和报告的有限监管指导,以及缺乏广泛可用的外部能力测试计划来保证质量。在这里,我们描述了ABO基因分型的方法,目前在开发ABO基因分型能力测试计划方面的举措,以及ABO基因分型的实验室质量保证考虑因素。