Establishment and evaluation of quality control products for 2019-nCoV
10.3760/cma.j.cn112866-20200514
- VernacularTitle:新型冠状病毒质控品的建立与评价
- Author:
Congrong LI
1
;
Rongfei CHE
;
Dan LIANG
;
Huanying ZHENG
;
Wei ZHAO
;
Changwen KE
Author Information
1. 中山大学中山医学院生物安全实验室，广州 510080
- Keywords:
2019-nCoV;
Quality control;
Homogeneity;
Stability
- From:
Chinese Journal of Experimental and Clinical Virology
2021;35(6):706-709
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish quality control products for 2019-nCoV detection, and provide reliable control materials for the quality evaluations of the 2019-nCoV detection kit based on fluorescence PCR.Methods:Virus strain was diluted to concentrations of 10 6, 10 5, 10 4, 10 3, 10 2 copies/ml which were used as positive control products. The mean value, standard deviation, coefficient of variability (CV) and tendency of the Ct values were calculated. The homogeneity and stability of the quality control products were tested. Results:Within the concentration gradients, Ct value and concentration of the control products were linearly related. In homogeneity test, the CVs of the quality control products with concentrations of 10 6, 10 5, 10 4, 10 3, 10 2 and 0 copies/ml were 4.60%, 2.67%, 2.22%, 2.04% and 2.50% respectively. In stability test, there was no significant linear trend with extended test time at 4 ℃. Conclusion:Evaluations of homogeneity and stability indicated that the quality control products were established successfully. And the products can be used for evaluation of 2019-nCoV detection kit based on fluorescence PCR.
