Performance verification of Mindray BC-5 D hematological control materials and its clinical application
10.3969/j.issn.1009-0754.2016.04.023
- VernacularTitle:迈瑞BC-5D全血质控物的性能验证及临床应用
- Author:
Dahai TANG
1
;
Bo YUE
;
Manjiao LIU
;
Jialei HE
;
Mengjie JIANG
;
Danjie LI
;
Shangzhen ZHANG
;
Xiufang LIU
Author Information
1. 解放军第四一一医院检验科
- Keywords:
Control materials;
Uniformity;
Stability;
Performance verification
- From:
Journal of Navy Medicine
2016;37(4):352-355,367
- CountryChina
- Language:Chinese
-
Abstract:
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.
