国产疫苗瓶温度标签不同热暴露后终点响应时间的研究  

Response time of a Chinese vaccine vial monitor to heat exposure

作　　者：杨星 曹雷[1] 余文周[1] 史小菊[2] 邓宗武[2] Yang Xing;Cao Lei;Yu Wenzhou;Shi Xiaoju;Deng Zongwu(National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China;Suzhou Institute of Nano-Tech and Nano-Bionics,Chinese Academy of Sciences,Suzhou 215123,Jiangsu,China)

机构地区：[1]中国疾病预防控制中心免疫规划中心,北京100050 [2]中国科学院苏州纳米技术与纳米仿生研究所,江苏苏州215123

出　　处：《中国疫苗和免疫》2021年第2期210-213,共4页Chinese Journal of Vaccines and Immunization

基　　金：中国疾控中心科研项目(59911811);江苏省重点研发计划项目(BE2017666)。

摘　　要：目的评价一款国产疫苗瓶温度标签(Vaccine vial monitor,VVM)在不同热暴露后的终点响应时间。方法将国产VVM(包括VVM2、VVM7、VVM14三种类型)各随机分入37℃水浴组、25℃水浴组,在实验室条件下测量每组VVM的颜色随温度-时间的累积变化,计算VVM终点响应时间,与WHO产品标准进行比较。结果本研究VVM2、VVM7、VVM14各纳入160个样本,在37℃恒温条件下平均终点响应时间分别为2.12(95%CI:2.10-2.15)d、6.27(95%CI:6.21-6.32)d、12.14(95%CI:12.02-12.26)d;在25℃恒温条件下平均终点响应时间分别为12.82(95%CI:12.68-12.96)d、28.91(95%CI:28.52-29.30)d、76.71(95%CI:75.94-77.47)d。结论本研究VVM7、VVM14在热暴露后的终点响应时间达到了WHO产品标准要求;VVM2不符合标准要求,尚需改进。Objective To evaluate end-point response time of a Chinese vaccine vial monitor(VVM) to varying heat exposures.Methods We randomly assigned Chinese VVMs(n=160 each of VVM2, VVM7, and VVM14 types) into a 37℃ water bath group and a 25℃ water bath group to measure cumulative color changes of VVMs under strict laboratory conditions. We calculated end-point response times and compared result with WHO VVM criteria.Results Average end-point response times of VVM2, VVM7, and VVM14 monitors in 37℃ were 2.12(95%CI: 2.10-2.15), 6.27(95%CI: 6.21-6.32), and 12.14(95%CI: 12.02-12.26) days, respectively. Average end-point response times in 25℃ were 12.82(95%CI: 12.68-12.96), 28.91(95%CI: 28.52-29.30), and 76.71(95%CI: 75.94-77.47) days.Conclusions The end-point response times of VVM7 and VVM14 met WHO VVM criteria;the VVM2 did not meet WHO criteria. The VVM2 should be improved.

关 键 词：疫苗瓶温度标签 响应时间 产品标准 

分 类 号：R186[医药卫生—流行病学]