摘要
目的确定安吉医药公司新包装试剂盒的保存条件和有效期。方法对不同储存温度(2～8℃、25℃以及37℃)与储存时间下的试剂盒主要组分冻干致敏红细胞和稀释液的稳定性进行研究。结果冻干致敏红细胞2～8℃2年、251年、37℃60d,各项观察指标均保持不变;致敏红细胞悬液2～8℃保存3d后,阴性符合率几乎降为0;新鲜配制的稀释液2～8℃2年、25℃与37℃60d,间断性敞口稀释液2～8℃、25℃与37℃各60d,各项观察指标均保持不变,长期敞口稀释液2～8℃、25℃以及37℃,3d后出现杂质,15d阴性符合率降为0。结论新包装试剂盒的主要组分稳定性好,其在2～8℃可保存2年,25℃与37℃可保存60d:稀释后致敏红细胞2～8℃保存3d有效:间断性敞口稀释液60d内可反复使用。
Objective To determine the storage conditions and validity duration of the new package reagents produced by Anji medical company.Methods The stability of the main component in the new package was tested under the different storage temperature(2—8℃,25℃and 37℃) and time,respectively. Results All observed indexes of the freeze—dried red blood cells remained unchanged under 2—8℃for 2 years,25℃for 1 year and 37℃for 60 days.The negative coincidence rate of diluted red blood cells suspension was almost reduced to 0 after 3 days under 2—8℃.All observed indexes remained unchanged for the freshly prepared diluents under 2—8℃for 2 years,25℃and 37℃for 60 days,and the diluents exposed to air intermittendy under 2—8℃,25℃and 37℃for 60 freshly prepared days;impurities would be found in the diluents exposed to air continually after 3 days under 2-8℃,25℃and 37℃,respectively,and the negative coincidence rate reduced to 0 after 15 days.Conclusion The validity duration of the new package reagents was 2 years under 2-8℃,and 60 days under 25℃and 37°C,respectively.The stability of the freeze—dried red blood cells and unopened diluents was very good,the validity duration of the diluted red blood cells was 3 days under 2—8℃and the diluents that intermittendy exposed to air was 60 days.
出处
《热带病与寄生虫学》
2012年第2期71-74,共4页
Journal of Tropical Diseases and Parasitology
基金
安徽省血防科研基金课题(№2009011)
关键词
日本血吸虫
试剂盒
稳定性
Schistosoma japonicum
Kit
Stability bserved
