摘要
目的观察Vero细胞HCP试剂盒的稳定性。方法将Vero细胞HCP试剂盒分别于2～8℃和37℃放置不同时间,检测试剂盒的灵敏度、特异性、准确性及精密性。结果试剂盒在2～8℃放置10个月的特异性及灵敏度均较好;检测参考品的回收率在91.7%～114.8%之间;对不同制品检测结果的变异系数均小于10%。37℃放置7d,试剂盒的灵敏度仍可达12.5ng/ml;放置10d,检测参考品的回收率在85%～115%之间;对不同制品检测结果的变异系数均小于10%。结论Vero细胞HCP试剂盒于2～8℃放置10个月及37℃放置7d的稳定性较好,仍可正常使用。
Objective To observe the stability of ELISA kit for host cell protein（HCP）of Vero cells. Methods The ELISA kit for HCP of Vero cells was stored at 2 ～ 8 and 37℃ for different time, and tested for sensitivity, specificity, accuracy and precision. Results After storage at 2 ～ 8℃ for 10 months, the kit showed high specificity and sensitivity, the recovery rate of reference determined by the kit was 91. 7% ～ 114. 8%, and the variation coefficient of determination results of various products was less than 10%. However, after storage at 37℃ for 7 d, the kit still reached a sensitivity of 12. 5 ng / ml; the recovery rate of reference determined by the kit after storage at 37℃ for 10 d was 85% ～ 115%, and the variation coefficient of determination results of various products was less than 10%. Conclusion The ELISA kit for HCP of Vero cells showed good stability after storage at 2 ～ 8℃ for 10 months or at 37℃ for 7 d, and could be used normally.
出处
《中国生物制品学杂志》
CAS
CSCD
2009年第12期1216-1218,共3页
Chinese Journal of Biologicals
