Preparation and effect evaluation of positive quality control reference for nucleic acid detection of 2019 Novel Corona Virus

ABSTRACT

Objective To prepare the indoor positive quality control reference for nucleic acid detection of 2019 Novel Corona Virus (2019-nCoV), investigate the feasibility of self-made quality control reference and evaluate the effect. Methods The positive control samples in the test kit from a third party were collected, diluted doubly with the virus preservation solution in which healthy human nasopharyngeal swabs were preserved, test samples to make a dilution, and determined for the Ct value of ORFlab gene by real-time fluorescent quantitative PCR. The dilutions with Ct values of about 31 and 34 were served as high-(nCov-H) and low-value quality control references (nCov-L) respectively and prepared in large quantities, then filled into small aliquots and stored at-80 °C to evaluate the uniformity and stability. Results The self-made indoor positive quality control reference for nucleic acid detection of 2019-nCoV showed good uniformity and good stability at various temperatures for storage, which could be kept stably at-80 °C for at least 6 months and could be controlled after repeated freezing and thawing for 3 times. Conclusion The self-made indoor positive quality control reference for nucleic acid detection of 2019-nCoV is simple to prepare, which has good uniformity and stability, and may be used as a substitute for commercial quality control for clinical test.