迈瑞BC-5D全血质控物的性能验证及临床应用

摘要

目的：对迈瑞BC-5 D全血质控物的质量进行评价分析。方法首先用迈瑞BC5300血液分析仪对迈瑞全血质控物进行均匀性和稳定性试验，然后用BC5300血液分析仪和美国COULTER LH780血液分析仪同时检测迈瑞BC-5D全血质控物、美国COULTER 5 C全血质控物和市临检中心产全血质控物，每日1次，每月更换新批次，连续检测6个月，比较6个批次3种质控物的稳定性。结果均匀性符合国家标准，在迈瑞厂家规定的90 d有效期内，短期、中期、长期稳定性与初期相比，差异无统计学意义（P＞0．05），符合厂家声明的开瓶稳定性14 d。3个品牌全血质控物稳定性的比较结果为：迈瑞BC-5D全血质控物稳定性与COULTER 5C质控物稳定性相近，优于临检中心产全血质控物。结论迈瑞BC-5D全血质控物性能良好，临床应用效果较好，且价格经济，适合临床推广。%Objective To evaluate and analyze the performance of Mindray BC-5D hematological control materials.Methods First, uniformity and stability tests were performed by using the Mindray BC5300 hematological analyzer.Then, the Mindray BC5300 hematological analyzer and the Coulter LH780 hematological analyzer were used simultaneously for the detection of Mindray BC-5D.The Coulter 5C hematological control materials and the domestic analyzer were used and replaced with new batches every month, to detect hematological control materials once for a succession of 6 months.Finally, the stability of the 3 hematological control materials from the 6 batches was compared accordingly.Results The uniformity of Mindray BC-5D hematological control materials met the na-tional requirements of the Pharmaceutical Industry Standards of the People′s Republic of China for whole blood quality control materials. Within the 90-day expiry date as specified by the manufacturer, no statistical significance could be seen in the short-term stability, mid-term stability and long-term stability, when comparisons were made between them(P>0.05).Therefore it conformed to the 14-day sta-bility requirements as declared by the manufacturer, once it was opened.The results of comparison for the stability of the 3 brands of hematological control materials were that the stability of Mindray BC-5D hematological control materials was similar to the Coulter 5C he-matological control materials, but was obviously superior to the control materials by the domestic analyzer.Conclusion The perform-ance of Mindray BC-5D hematological control materials was of better quality, more economical and had better clinical efficacy, which was worth further clinical extension.