核酸标准物质定值的实验体系研究

doi:10.3969/j.issn.1000-1158.2020.11.20

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Abstract With the rapid development of molecular in-vitro diagnostics diagnostic (IVD) technology, the market demand for different types of traceable nucleic acid reference materials (RMs) is becoming more and more urgent. However, the diversifying demands for IVD products make it difficult to develop nucleic acid RMs. Fortunately, the physical-chemical characteristics of nucleic acids are similar, and there are many common points in the quantitating process. nucleic acids have many similar physical-chemical characteristics and have a lot in common in the quantitating process. Four ctritical factors were elaborated about quantitative experiments in developing process of nucleic acid RMs, which contain nucleic acid sampling volume, dilution, selection of certification method and data analysis. It can be concluded that the sampling volume, loading concentration and optimizing quantitative range of instruments are critical to establish the correct experiment system. Thus, the experimental error in the nucleic acid quantitating process can be reduced and the wrong results can be avoided.

Key words： metrology nucleic acid reference material nucleic acid quantitation in-vitro diagnostic binomial distribution

Received: 25 September 2018 Published: 02 November 2020

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TB99

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	Articles by authors
	LI Da
	WANG Jun
	YANG Zhong
	WANG Hui-ru

Cite this article:

LI Da,WANG Jun,YANG Zhong, et al. Experimental Design Analysis of Developing Quantitative Nucleic Acid Reference Materials[J]. Acta Metrologica Sinica, 2020, 41(11): 1436-1442.

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http://jlxb.china-csm.org:81/Jwk_jlxb/EN/10.3969/j.issn.1000-1158.2020.11.20 OR http://jlxb.china-csm.org:81/Jwk_jlxb/EN/Y2020/V41/I11/1436

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