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 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 genotyping proficiency testing programs, and laboratory quality assurance considerations for genotyping.

中文翻译：

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对 ABO 血型基因分型的需求日益增长以及对实验室实施的质量保证影响

ABO 血型抗原是自身和非自身免疫的关键决定因素，并且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，可以介导针对不相容输注血细胞和移植组织的病理反应。ABO 抗原和同种凝集素的实验室检测对于安全有效的输血和移植至关重要。ABO 抗原检测传统上依赖于血清学检测。然而，越来越需要评估 ABO 抗原的遗传分析，以便在血清学检测可能不明确或无法准确执行的情况下评估 ABO 血型。ABO 基因分型的临床需求正在通过多种分子诊断方法的开发得到解决。最近的数据清楚地证明了基因分型在实体器官移植中的潜在效用，但广泛实施却进展缓慢。我们认为这种滞后与实验室检测的实际考虑有关，包括对这些检测的性能和报告的监管指导有限，以及缺乏广泛可用的质量保证外部能力验证计划。在这里，我们描述了 ABO 基因分型的方法、当前开发基因分型能力验证计划的举措以及基因分型的实验室质量保证注意事项。