核酸标准物质定值的实验体系研究

Experimental Design Analysis of Developing Quantitative Nucleic Acid Reference Materials

分子体外诊断技术的高速发展,市场对不同种类具有溯源性的核酸标准物质的需求越来越迫切。然而,核酸种类的多样性给标准物质的研制带来了不小的困难。但核酸物理化学特性相近,定值过程有诸多共同点。从核酸取样量、核酸的稀释、定值方法的选择和数据结果分析4个方面详细地阐述了核酸标准物质在定值实验过程中涉及到的关键因素。通过分析得出,核酸定值的关键在于样品取样量、上样浓度和最佳定量范围的确定,从而建立正确的实验体系,减小核酸定值过程中产生的实验误差,避免错误的结果。

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.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.