全自动血型分析仪使用前性能验证与评价  

Performance Verification and Evaluation of Automatic Blood Group Analyzer

作　　者：王敏[1] 于慧芳[1] 谭安超 苏莉[1] WANG Min;YU Hui-fang;TAN An-chao;SU Li(Blood Transfusion Department of Guizhou Provincial People’s Hospital,Guizhou Guiyang 550002)

机构地区：[1]贵州省人民医院输血科,贵州贵阳550002

出　　处：《中国医疗器械信息》2024年第17期45-47,176,共4页China Medical Device Information

摘　　要：目的:投入临床使用前对Ortho Vision Max全自动血型分析仪进行性能验证,确保该仪器能够准确可靠地完成检测任务。方法:选取一批经过BioRad IH-1000全自动血型分析仪验证过的ABO血型正反定型样本、RhD血型样本及不规则抗体筛查样本作为参照,利用Ortho Vision Max全自动血型分析仪重新进行检测,以此对该仪器开展血型鉴定、不规则抗体筛查等方面的内容,涉及对精确度的检验、对其长期稳定性的检测,对污染率实施评估,且进行抗干扰能力试验。此外,选取16份具有不同血型抗体效价的样本,分别采用手工卡式微柱凝胶法与Ortho Vision Max全自动血型分析仪进行检测,将两者结果进行对比研究。结果:Ortho Vision Max全自动血型分析仪在各项性能测试中表现优秀,不仅其检测准确性、稳定性达标,而且有效控制了携带污染风险并表现出良好的抗干扰性;同时,该仪器在血型抗体效价测定方面也符合预期标准。结论:Ortho Vision Max全自动血型分析仪能完全满足临床应用的要求,可以投入日常使用。Objective:To verify the performance of Ortho Vision Max automatic blood group analyzer before clinical use to ensure that the instrument can complete the detection task accurately and reliably.Methods:Select a batch of BioRad IH-1000 automatic blood type analyzer verified ABO positive and reverse design samples,RhD blood type samples and irregular antibody screening samples as a reference,using the Ortho Vision Max automatic blood type analyzer to test,the instrument for ABO blood type identification,RhD identification,irregular antibody screening in four items of precision verification,long-term stability test,carrying pollution rate assessment and anti-interference ability test.In addition,16 samples with different blood group antibody titers were selected and tested by manual card microcolumn gel method and Ortho Vision Max automatic blood group analyzer,and the two results were compared.Results:Ortho Vision Max automatic performed well in various performance tests,not only achieving the detection accuracy and stability,but also effectively controlled the risk of contamination and showed good anti-interference.Meanwhile,the instrument also met the expected standards in the determination of blood group antibody titer.Conclusion:Ortho Vision Max automatic blood type analyzer can fully meet the requirements of clinical application and can be put into daily use.

关 键 词：性能验证 输血相容性检测 ORTHO VISION MAX 

分 类 号：R446.1[医药卫生—诊断学]