Six suppliers, including Huarakang, were tested by the customer for quality performance at 4°C, 25°C, 37°C, and 3 days and 7 days at each temperature. The test results show that the stability, effectiveness, and uniformity of the inactivated virus produced by Hualikang are the best. The test results are as follows.
Interpretation of the results.
This electropherogram is mainly used to examine the performance of the technical parameter of nucleic acid (especially RNA nucleic acid) integrity in the product, especially in the preservation solution.
In the technical parameter "integrity", it is specified that.
. Agarose gel electrophoresis of viral nucleic acid in preservation solution should be a clear and bright main band without trailing and dispersion.
If there is trailing and dispersion, it is usually due to the degradation of viral nucleic acid in the preservation solution. Therefore, the integrity becomes an important indicator of the stability of the preservation solution.
This electropherogram should be observed from three aspects
1. The electropherogram of a preservation solution to be investigated should be at the same level of the main band at 4℃, 25℃ at room temperature and 37℃. If it is the same horizontal line, it proves that the preservation solution is stable at 4℃, 25℃ and 37℃, and there is no phenomenon that the stability decreases with the change of temperature.
2. The electrophoresis diagram of a preservation solution to be investigated should be at the same level as the Marker target band at 4℃, 25℃ and 37℃ to show that the molecular weight of the viral nucleic acid in the preservation solution is in accordance with the regulations, if it is not at the same level as the Marker target band, it means that the nucleic acid is degraded.
3. The electropherogram of a certain preservation solution to be investigated should be basically straight rather than significantly curved at 4℃, 25℃ at room temperature and 37℃ at the main band.
According to the above three judgment criteria, we then found
In Fig. 1, some of the preservation solutions (preservation solution No. 13) had obvious trailing and dispersion (preservation solution No. 13), and some of them were not at the same level with the Marker target bands (such as preservation solution No. 19 and preservation solution No. red-RY), and some of the main bands were obviously curved (preservation solution No. 6 and preservation solution No. red-RY). The main stripes were clearly curved (preservation solution No. 6). These indicate that the nucleic acid in these four preservatives was degraded to different degrees. The stability of the preservative solution (labeled: hrs) and the preservative solution No. 18 showed a lack of stability compared with that of the preservative solution produced by Hualikang.
The stability of the preservation solution (marked as: hrs) and No. 18 preserved solution produced by Hualikang Company met the requirements, and the technical indexes of nucleic acid preservation stability of the preservation solution (marked as: hrs) and No. 18 preserved solution produced by Hualikang Company were significantly better than the preservation solutions of Red-RY, No. 6 preserved solution, No. 13 preserved solution and No. 19 preserved solution representing four different manufacturers respectively.
