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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 Vero cell HCP kit. Methods The Vero cell HCP kit was placed in different time at 2 ~ 8 ℃ and 37 ℃, and the sensitivity, specificity, accuracy and precision of the kit were tested. Results The specificity and sensitivity of the kit were good at 2-8 ℃ for 10 months. The recoveries of the reference products ranged from 91.7% to 114.8%. The coefficients of variation for different products were less than 10%. The sensitivity of the kit can reach 12.5ng / ml when placed at 37 ℃ for 7 days. The recovery rate of reference samples after 10 days of storage is between 85% and 115%. The coefficients of variation for different products are less than 10%. Conclusion The stability of Vero cell HCP kit placed at 2-8 ℃ for 10 months and at 37 ℃ for 7d is good and can still be used normally.