【摘要】 目的通过与进口同类试剂卡的试验比对,考核国内某公司研制开发的抗人球蛋白检测卡(微柱凝胶法)的临床应用价值。方法通过对照设计,严格按照标准操作规程,使用某国产和进口两组微柱凝胶试剂卡分别对贵州省人民医院住院期间不同年龄段、多病种患者样本进行直接抗人球蛋白试验(以下简称直抗试验)、间接抗人球蛋白试验(不规则抗体筛查试验,以下简称抗体筛查试验)、交叉配血试验比对。结果两组试剂卡1 018例标本直抗试验和抗体筛查试验的检测结果符合率100%;两组试剂卡1 006例样本交叉配血试验的检测结果符合率100%,其中包括了26对(52例)采用不同血型、直抗试验阳性、抗体筛查试验阳性的特殊样本,两组试剂均检测出相合样本6例、不相合46例。结论该国产试剂卡不受年龄和疾病因素的影响,与现行进口试剂卡结果一致,可运用于所有微柱凝胶法检测的项目,具有较高的临床应用价值。更多还原

【Abstract】 Objective The clinical application value of the anti-human globulin test card(microcolumn gel method)developed by a domestic company was evaluated by comparing the test results with an imported similar reagent card.Methods Through contrast design and a strict accordance with the standard operating procedures, test results of two groups of microcolumn gel reagent cards were compared. Specifically, the direct anti-human globulin test(indirect anti human globulin test) and indirect anti-globulin test of different age groups and patients with multiple diseases during hospitalization in Guizhou People’s Hospital were conducted. Then antibody screening test, hereinafter referred to as antibody screening test, cross matching test were conducted.Results The coincidence rate of direct antibody test and irregular antibody screening was 100% in 1 018 samples of two groups of reagent cards and 100% in cross matching test of 1 006 samples of two groups of reagent cards, including 26 pairs(52 cases) of special samples with different blood types, positive direct antibody test and positive irregular antibody screening. Six matched samples and 46 inconsistent samples were detected.Conclusion The domestic reagent card is not affected by age and disease type factors, and is consistent with the results of the current imported reagent card, suggesting that it can be used in all microcolumn gel detection items, and has a high clinical application value.更多还原