The Research of Quantification for HPV16 and HPV18 Pseudovirus Nucleic Acid Reference Materials
LI Hui-jie1,2,CHEN Gui-fang3,DONG Lian-hua2,YANG Jia-yi2,YANG Jing-ya1
1. College of Food Sciences & Technology, Shanghai Ocean University, Shanghai 201306, China
2. Center for Advanced Measurement Science, National Institute of Metrology, Beijing 100029, China
3. College of Chemistry Engineering, Shenyang University of Chemistry Technology, Shenyang, Liaoning 110142, China
Abstract：Using pseudoviruses containing HPV16 and HPV18 L1 gene sequences as candidate materials, the copy number concentration of L1 gene was detected by digital PCR quantitative method, and the homogeneity and stability of the reference materials were verified. HPV16 and HPV18 pseudovirus nucleic acid reference materials (NIM-RM5213 and NIM-RM5214) were developed. The standard value of copy number and expanded uncertainty (k=2) of the two reference materials are (1.52±0.13) ×103copies/μL, (1.29±0.12) ×103copies/μL。 The calibration results of the two reference materials were verified by multiple testing platforms, and the relative standard deviation of the calibration results was within 5%. The mentioned standard material can provide reference for the quality control of the whole process of HPV detection, help to improve the accuracy and effectiveness of HPV nucleic acid detection process, and has broad application prospects.
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2023, Vol. 44 
