The study on the stability of commercial quality control products of Hepatitis C virus RNA

Abstract

Objective To observe the stability of commercial quality control products of hepatitis C virus RNA. Methods The serum standard substance S3 (the concentration level was 105 IU/ml) and S5 (the concentration level was 103 IU/ml) of Hepatitis C virus nucleic acid (HCV RNA) were testing under normal conditions. Using self-preparing internal quality control materials as quality control products each experiment, and analyzing the results of commercial quality control when quality control was in the control. The quality control chart was drawn using the mean () and standard deviation (s) determined by the previous 20 data. When single test result was more than ±3s or two consecutive test results were more than + 2s or -2s at the same time, they were judged to be out of control. Results The mean of the low and high values were 0.31 and 6.51 respectively, and the standard deviation were 0.25 and 0.13, respectively, which were less than 0.32. The and s could be used as the target and standard deviation of the quality control map, and using them to draw the L-J diagram. The mean of the S3 and S5 were 5.45 and 3.05, respectively, and the standard deviation were 0.09 and 0.30, respectively. Using and s as the target and standard deviation to draw the quality control map. In the 77 experiments, the result of quality control S3 in the 32th time was exceeded -2s, and the results from 32th to 77th were all lower than the target value except the 64th result . The test results of quality control S5 were more than -2s in the 13th, 24th and 32th times and was out of control in the 36th time. Conclusion The stability of commercial quality control product S3 of HCV RNA is better in 4 months, and the quantitative value began to decrease after 4 months. The commercial quality control product S5 of HCV RNA is stable within 10 months. Key words: Commercial quality control products; Hepatitis C virus; Quality control chart; Stability