Performance evaluation of automated blood grouping analyzer AutoVue Innova for unexpected antibody screening
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摘要: 目的 对AUTOVUE INNOVA全自动血型分析仪中意外抗体筛查项目进行性能分析,评价其是否满足临床应用需求。方法 收集BIORAD-IH1000全自动血型分析仪检测意外抗体筛查结果为阳性、阴性样本各20例,国家卫生健康委临床检验中心室间质评意外抗体筛查样本5例,所有阳性结果凝集强度范围+/-~4+,分别从方法符合率、准确度、重复性、携带污染4个方面对AUTOVUE INNOVA全自动血型分析仪进行性能评价。结果 对AUTOVUE INNOVA全自动血型分析仪意外抗体筛查试验性能进行评价,其方法符合率100%、准确度100%、重复性结果一致,且凝集强度差异无统计学意义,未发现携带污染。结论 AUTOVUE INNOVA全自动血型分析仪意外抗体筛查试验可满足临床应用需求。
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关键词:
- AUTOVUE INNOVA全自动血型分析仪 /
- 意外抗体筛查 /
- 性能评价
Abstract: Objective To evaluate the performance of unexpected antibody screening test detected by automated blood grouping analyzer AutoVue Innova, and assess whether it meets clinical application requirements.Methods A total of 45 samples including 20 positive, 20 negative and 5 samples from national center for clinical laboratories were detected by automated blood grouping analyzer BIORAD-IH1000 for unexpected antibody screening. The agglutination intensity of positive results ranged from +/- to 4 +. It was evaluated from four aspects: concordance rate, accuracy, repeatability and carryover contamination.Results The concordance rate, accuracy and repeatability of automated blood grouping analyzer AutoVue Innova for unexpected antibody screening test were all 100%, and there was no significant difference in agglutination intensity, no carryover contamination was found.Conclusion The performance evaluation of automated blood grouping analyzer AutoVue Innova for unexpected antibody screening testing is reliable, which could be applied to clinical detection. -
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