Wen C K, Zhou C N, Jiang L, Chen Z G
Jiangsu Provincial Center For Disease Control And Prevention, Nanjing 210009, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2017 Mar 6;51(3):248-251. doi: 10.3760/cma.j.issn.0253-9624.2017.03.011.
To evaluate the failure time of vaccine vial monitor (VVM) used for oral poliovirus vaccine (OPV) at 25 ℃ and 37 ℃. 160 copies of VVM were produced by a company, the model was QM5D37A, samples were taken from different batches by using the method of random number table . 100 bottles of vaccine were produced by a domestic company, and samples were taken from different batches by using the method of random number table. 160 copies of labels were placed in the incubator at 25 ℃ and 37 ℃, which were used to measure the mutative color of the active region. When the values of color were equal to 40, the color of active region was the same with the reference color, and the VVM was failed. 100 bottles of vaccine were placed in the incubator at 25 ℃ and 37 ℃, which were used to measure the vaccine titer. When total vaccine titer was less than 6.12 CCID50 or vaccine titer of typeⅠ was less than 6.0 CCID50 or vaccine titer of type Ⅲ was less than 5.5 CCID50, the vaccine was failed. We drew the graph of mutative color to calculate the failure time range of VVM According to the graph , we can determine that whether the failure time of VVM was later than the time of vaccines by the data of OPV . The earliest failure time of OPV was 21 days at 25 ℃, and the number of samples was one; The earliest Failure time of VVM was 12.5 days at 25 ℃, and it was less than the earliest failure time of OPV. The earliest failure time of OPV was 4.0 days at 37 ℃, and the number of samples was one; The earliest Failure time of VVM was 3.1 days at 37 ℃, and it was equal to the earliest failure time of OPV. We could know that the failure time of VVM was always earlier than the failure time of vaccines at the same temperatures . The latest failure time of VVM was equal to the earliest failure time of vaccines at 37 ℃. All of the failure times of samples were earlier than that of vaccines at 25 ℃.
评估用于口服脊髓灰质炎疫苗（OPV）的疫苗瓶监测器（VVM）在25℃和37℃条件下的失效时间。某公司生产了160份VVM，型号为QM5D37A，采用随机数表法从不同批次中取样。国内某公司生产了100瓶疫苗，同样采用随机数表法从不同批次中取样。将160份标签置于25℃和37℃的培养箱中，用于测量活性区域的变色情况。当颜色值等于40时，活性区域的颜色与参考颜色相同，VVM失效。将100瓶疫苗置于25℃和37℃的培养箱中，用于测量疫苗滴度。当总疫苗滴度低于6.12 CCID50或Ⅰ型疫苗滴度低于6.0 CCID50或Ⅲ型疫苗滴度低于5.５CCID50时，疫苗失效。绘制变色曲线图以计算VVM的失效时间范围。根据该图，我们可以通过OPV的数据确定VVM的失效时间是否晚于疫苗的失效时间。OPV在25℃下最早的失效时间为21天，样本数量为1个；VVM在25℃下最早的失效时间为12.5天，且早于OPV最早的失效时间。OPV在37℃下最早的失效时间为4.0天，样本数量为1个；VVM在３７℃下最早的失效时间为3.1天，与OPV最早的失效时间相同。我们可以知道，在相同温度下，VVM的失效时间总是早于疫苗的失效时间。VVM的最晚失效时间与疫苗在37℃下最早的失效时间相同。所有样本的失效时间均早于25℃下疫苗的失效时间。
