Digital PCR as a Universal Molecular Diagnostic Standard

A reliable primary reference measurement procedure is the key to many forms of measurement across a diverse range of scientific research. The ability of digital PCR to quantify nucleic acids without the need for calibration will likely make it an essential tool for laboratories around the world to calibrate their measurements against.

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Across all areas of life science research, scientists are increasingly aware of the need for the absolute quantification of nucleic acids. To make their analyses actionable, they want to directly measure copies of a molecule, rather than rely on a simple positive or negative result. The challenge, however, is that any tool that quantifies nucleic acids needs to be standardized against a universal reference material produced by an authoritative body such as the World Health Organization. If this practice is not in place, the results obtained using this tool will not be reproducible across different tests, laboratories or locations.

Currently, there are no convenient primary reference measurement procedures for quantifying these standards. As a result, it is difficult for research laboratories and diagnostics manufacturers to harmonize their nucleic acid quantification methods and produce reliable assays. Fortunately, several metrology laboratories – labs that study the science of measurement – are seeking ...

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