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ORTHO Innov全自动分析仪在血型鉴定中的性能评价

     

摘要

Objective To evaluate automatic ORTHO Innova analyzer for identification of blood groups of ABO. Methods ABO blood groups were identified with blood group analyzer and tube method for accuracy evaluation in 12 463 qualified samples. Each 10 cases of AB and O group, 1 case of B3 group, 2 cases of Ax group were tested for precision e-valuation. Each 3 qualified and unqualified samples were tested for carry-over rates. Simultaneously, to explore the effect of unqualified samples on results. Results Compared with tube method,the accuracy of blood group analyzer was not different (P>0. 05). In bloodgrouping with normal ABO group samples,the results of blood group analyzer was entirely coincidental in the repeating test. Occasionally wrong with 0. 5+ existed in subgroup test. The carry-over rate was 100. 00% in samples with bigger floating blood clots,but 0 in other samples. There were different influences on bloodgrouping in abnormal samples. Conclusion The accuracy and precision of blood group analyzer are high for normal ABO bloodgrouping, no carry over,but the sample must be qualified.%目的 对ORTHO Innova全自动血型及配血分析系统在ABO血型鉴定中的性能进行评价.方法 对12463例合格标本进行仪器法和试管法ABO血型鉴定以评价准确度;选取AB型、O型各10例,已确认为B3型1例、Ax型2例标本,评价精密度;选取合格和不合格各类标本各3例以评价交叉污染;并探讨不合格标本的影响情况.结果 仪器法准确度与试管法相比差异无统计学意义(P>0.05);仪器法对正常血型标本重复检测完全符合;对亚型检测时偶有0.5+的误差;有较大漂浮凝块标本的携带污染率为100.00%,其他标本携带污染率为0;不合格标本对检测结果有不同程度影响.结论 该仪器在正常ABO血型鉴定中准确度和精密度高,无携带污染,但使用标本必须合格.

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