国产单抗血型定型试剂质量研究

对国产抗A、抗B单抗血型试剂进行了质量、稳定性、与亚型细胞识别检定及临床应用。临床应用对象包括1岁及1岁以下婴儿、59及59岁以上老人、肿瘤患者及非肿瘤患者、健康献血员、少数民族人群。共414044人，正反定型及与人血清试剂相符率为99．998％。质量及临床应用结果表明，我国单抗血型定型试剂，已达到人血型定型试剂要求，可以取代人血清型试剂推广应用。

Study on Quality of Domestic McAb Kit for Blood Typing

A domestic kit for the blood typing of anti-A and anti-B McAbs was used fora clinical trial in 414044 subjects after the quality, stability and specificity of it was studied.The 414044 subjects included the infants aged not more than 1 year, the old people aged morethan 59 years, the patients with or without tumors, healthy blood donor and minorities. Theresult showed that the coincidence rate of direct and reverse typing results using the kit andhuman serum reagent was 99. 998%. It proved that the domestic kit reached the requirementsfor blood typing kit, and could be used for clinical examination instead of human serumreagent.