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.
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2020, Vol. 41 
