不规则抗体筛查室内质控品的制备及初步应用

Preparation and evaluation of laboratory internal quality control materials for screening of irregular antibody

目的自制不规则抗体筛查室内质控品并进行初步应用。方法选择商品化单克隆Ig G类抗D原液作为强阳性质控品,其稀释液作为弱阳性质控品,不规则抗体阴性的献血员AB型血浆作为阴性质控品。将强阳性、阴性质控品连续测定20次,确定其靶值;将单克隆Ig G类抗D倍比稀释,确定红细胞凝集强度达到2＋的最高稀释倍数作为弱阳性质控品的最佳稀释度,连续测定20次。质控品与待检标本同时按标准操作规程进行测定,每天测定1次,共6个月。结果强阳性质控品靶值为4＋,弱阳性质控品靶值为2＋,最佳稀释度为1∶500,其质控范围为1-3＋。弱阳性质控品在6个月的使用过程中出控4次,强阳性、阴性质控品检测结果均在控。结论实验室自制不规则抗体筛查室内质控品可行,功能上能够完全满足对检测项目的质量控制要求。

Objective To prepare laboratory internal quality control material for screening irregular antibody and evaluate its applications. Methods The commercialized monoclonal IgG of anti-D was served as the strong positive quality control material, the diluted IgG solution of anti-D as the weakly positive quality control material, and the plasma from AB blood type donor with negative irregular antibody as negative quality control materials. The strong positive and negative quality control materials were determined repeatedly for 20 times to ascertain the target value. The highest dilution of erythrocyte agglutination intensity 2 ＋ was regarded as the optimal dilution degrees of weak positive quality control material by double dilution of the monoelonal anti-D IgG and the determination was repeated for 20 times. The quality control materials and untested samples were simuhaneously determined everyday during 6 months. Results The target value of strong positive quality control materials was 4 ＋. The target value of weakly positive quality control materials was 2 ＋ with optimal dilution of 1： 500 and range of quality control from 1 ＋ to 3 ＋. During the 6 months, the weakly positive quality control material was out of the range of quality control for four times, whereas both the strong positive and negative quality controls materials were in the range of control. Conclusion The quality control materials prepared in laboratory were available for determination of irregular antibody and its function could meet the requirements of the test items.