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目的:用实验室手段和大样本临床验证方法,研究IgA类抗血型单克隆抗体(mAb)用作人血型定型试剂的可行性。方法:根据《中国生物制品规程》、新药临床验证以及有关要求,检测规模化生产的mAb的有关指标,并在人群中用反向定型等方法进行验证。结果:所有指标均达到或超过国家标准,临床应用未出现错判和误判。结论:所生产的mAb完全可以用于中国人ABO血型定型。
OBJECTIVE: To study the feasibility of using IgA anti-blood type monoclonal antibody (mAb) as a human blood type setting reagent by means of laboratory tests and large sample clinical validation. Methods: According to the “China Biological Products Regulations”, the clinical validation of new drugs and the related requirements, the scale of mAb was tested and relevant indicators were verified in the population by reverse stereotyping and other methods. Results: All indexes reached or exceeded the national standard, clinical application did not appear wrongly judged and misjudged. Conclusion: The produced mAb can be used for Chinese ABO blood group typing.