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Digital PCR for the Characterization of Reference Materials



Megan Cleveland, Hua-Jun He, Mojca Milavec, Young-Kyung Bae, Peter Vallone, Jim Huggett


Well characterized reference materials are essential to ensuring the harmonization and accuracy of nucleic acid-based tests (such as qPCR); digital PCR (dPCR) can measure the absolute concentration of a specific nucleic acid sequence in a background of non-target sequences, making it ideal for the characterization of nucleic acid-based reference materials. National Metrology Institutes are increasingly using dPCR to characterize and certify their reference materials, as it offers several advantages over indirect methods, such as UV-spectroscopy. While dPCR is gaining widespread adoption, it requires optimization and has certain limitations and considerations that users should be aware of when characterizing reference materials. This review highlights the technical considerations of dPCR, as well its role when developing and characterizing nucleic acid-based reference materials.
Molecular Aspects of Medicine


digital PCR, dPCR, reference materials, molecular diagnostics


Cleveland, M. , He, H. , Milavec, M. , Bae, Y. , Vallone, P. and Huggett, J. (2024), Digital PCR for the Characterization of Reference Materials, Molecular Aspects of Medicine, [online],, (Accessed April 23, 2024)
Created February 14, 2024, Updated February 20, 2024