摘要
目的 建立ABO血型反定型试剂的质控方法和质量标准.方法 用抗P、抗M、抗N、抗C、抗c、抗E、抗e试剂检测O型血浆样本,选择分别与抗P、抗M、抗C、抗e试剂反应呈(卅)强阳性样本,和与抗P、抗N、抗c、抗E试剂反应呈(卅)强阳性样本各2份,配制ABO血型反定型用O型细胞.分别对两个厂家提供的和自制的ABO血型反定型用O型细胞进行抗原性检测,同时进行外观、特异性、ABH抗原性、亲和力、溶血率、稳定性检测,并检测35份含IgM类不规则抗体的阳性血浆样本,对比检出率.结果 自制的ABO血型反定型用O型细胞与抗P、抗M、抗N、抗C、抗c、抗E、抗e试剂反应均呈++以上,而其他两个厂家提供的ABO血型反定型试剂均有部分抗体漏检；外观、特异性、ABH抗原性、亲和力、溶血率、稳定性检测均无明显差异,符合相关要求；自制的ABO血型反定型用O型细胞可检出所有IgM类不规则抗体,无漏检,而其他两个厂家提供的ABO血型反定型试剂均有部分血浆样本漏检.结论 本研究建立的质控方法和质量标准适用于IgM类不规则抗体的检出.
Abstract
Objective To develop a method and a standard for quality control of inverse ABO blood grouping reagents. Methods Plasma samples of group 0 were determined by anti-P, anti-M, anti-N, anti-C, anti-c, anti-E and anti-e reagents respectively , of which two strong positive samples with reaction results of with anti-P, anti-M, anti-C and anti-e reagents and two strong positive samples with reaction results of anti-P, anti-N, anti-c and anti-E reagents were selected to prepare blood cells of group 0 for inverse ABO blood grouping. The blood cells of group 0 for inverse ABO blood grouping, manufactured by two manufacturers and prepared by the authors, were tested for antigenicity, observed for appearance, and determined for specificity, ABH antigenicity, affinity, haemolysis rate and stability. Thirty-five plasma samples positive for irregular IgMs were determined by the prepared reagents, and the detection rates were compared. Results All the blood cells of group 0 prepared by the authors showed reaction results of more than with anti-P, anti-M, anti-N, anti-C, anti-c, anti-E and anti-e reagents. However, partial antibodies failed to be tested by the inverse ABO blood grouping reagents provided by two manufacturers. All the appearances, specificities, ABH anti-genicities, affinities, haemolysis rates and stabilities of the reagents met the relevant requirements and showed no significant difference. All the irregular IgMs were detected by the prepared reagent, partial of which failed to be detected by the reagents provided by two manufacturers. Conclusion The method and standard for quality control of inverse ABO blood grouping established by the authors were suitable for detection of irregular IgMs
NETL
NSTL
维普
万方数据