Progress in the Development and Application of RNA Reference Materials

doi:10.13560/j.cnki.biotech.bull.1985.2023-1202

Abstract

Abstract:

RNA reference materials is an important physical standard to ensure the accuracy and consistency of nucleic acid in vitro diagnostic data. It is widely used in the detection of viral diseases. It can also be used in calibration instruments, evaluation kits and proficiency testing, which purpose is to ensure the accuracy and consistency of the measurement process and measurement results. Since 1997, WHO has developed the first hepatitis C nucleic acid international reference material for nucleic acid amplification technology, which makes the results of different laboratories and different methods in the world comparable. By 2023, there are nearly 100 kinds of RNA certified reference materials released by China on the National Sharing Platform for Reference Materials. The research and application of RNA reference materials have been paid more and more attention by metrology institutions, relevant international academic organizations and enterprises all over the world. Especially after the outbreak of the novel coronavirus epidemic, the development of RNA reference materials has become a hot spot in the development of biological reference materials. With the continuous development of the reference materials development technology, the accuracy of the reference materials has also been improved, which provides a guarantee for the accuracy and consistency of the measurement results. The preparation methods, sub-package, fixed value technology, uncertainty evaluation and application fields of RNA reference materials are briefly reviewed, which provides a reference for the development of RNA reference materials and their future applications in various fields.

Key words: RNA, reference material, characterization of reference materials, stability, homogeneity, evaluation of uncertainty

WANG Dan, ZHAO Wen-jiang, QI Xin, LI Xin-ran, LI Kai, FAN Li, LI Liang. Progress in the Development and Application of RNA Reference Materials[J]. Biotechnology Bulletin, 2024, 40(6): 105-113.

Figures/Tables 2

References 38

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标准物质名称Name of reference standard	定值结果Quantification result	不确定度Uncertainty/%	参考文献Reference
丙型肝炎病毒脱氧核糖酸血清标准物质	1.29×10⁵ IU/mL	18.6	[8]
猪繁殖与呼吸综合征病毒欧洲株（PRRSV LV）核酸标准物质	1.83×10⁴ copies/μL	12	[12]
新城疫病毒（NDV Lasota株）核酸标准物质	1.7×10⁵ copies/mg	17.6	[27]
新型冠状病毒体外转录RNA标准物质（新冠） ORF1ab基因	7.70×10⁵ copies/μL	16.7	[28]
新型冠状病毒体外转录RNA标准物质（新冠） E基因	4.30×10⁵ copies/μL	15	[28]
新型冠状病毒体外转录RNA标准物质（新冠） N基因	6.10×10⁵ copies/μL	23	[28]
HPV16 E6/E7 RNA假病毒标准物质	1.10×10³ copies/μL	17	[29]
猪繁殖与呼吸综合征病毒美洲变异株（PRRSV JXA1）核酸标准物质	1.13×10⁴ copies/μL	16	[30]

标准物质名称Name of reference standard	定值结果Quantification result	不确定度Uncertainty/%	参考文献Reference
丙型肝炎病毒脱氧核糖酸血清标准物质	1.29×10⁵ IU/mL	18.6	[8]
猪繁殖与呼吸综合征病毒欧洲株（PRRSV LV）核酸标准物质	1.83×10⁴ copies/μL	12	[12]
新城疫病毒（NDV Lasota株）核酸标准物质	1.7×10⁵ copies/mg	17.6	[27]
新型冠状病毒体外转录RNA标准物质（新冠） ORF1ab基因	7.70×10⁵ copies/μL	16.7	[28]
新型冠状病毒体外转录RNA标准物质（新冠） E基因	4.30×10⁵ copies/μL	15	[28]
新型冠状病毒体外转录RNA标准物质（新冠） N基因	6.10×10⁵ copies/μL	23	[28]
HPV16 E6/E7 RNA假病毒标准物质	1.10×10³ copies/μL	17	[29]
猪繁殖与呼吸综合征病毒美洲变异株（PRRSV JXA1）核酸标准物质	1.13×10⁴ copies/μL	16	[30]