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RM 8376 Microbial Pathogen DNA Standards for Detection and Identification


Metagenomic Next Generation Sequencing (mNGS) promises to revolutionize infectious disease diagnostics. However, the analytical performance of this technology is still not well understood, especially with respect to healthcare-related applications. NIST is developing materials and methods that will help validate these technologies, bringing them from the benchtop to the bedside.


RM 8376 consists of 20 individual gDNA components from 19 bacterial strains and 1 human reference genome. Its purpose is to enable developers and regulators to evaluate the analytical performance of metagenomic next generation sequencing (mNGS) tools. The material is certified for chromosomal copy number based on droplet digital PCR analysis, providing ground truth abundance for making user-defined, fit-for-purpose gDNA mixtures. Assembled genomes are available on the NCBI website (BioProject PRJNA605254). This RM will allow users to evaluate potential sources of mNGS bias and improve overall confidence in the result.

Ongoing Work with this Standard

16S Copy Number -- We are currently assessing the 16S copy number concentration for each component in this material. Though a non-certified value, this additional information should add to the utility of RM 8376 for other applications.

Use Cases -- This material can find utility in metagenomics as a control, with the DNA mixed into a background matrix and processed, mixed with other DNA as an internal control, or simply used as-is to test a portion of a workflow. As these projects progress, we will post progress and links to relevant publications.

Major Accomplishments

The material can be purchased from the NIST Store.

The Report of Analysis for RM8376 has been published as a NIST special publication and includes a detailed description of the material characterization and the droplet digital PCR (ddPCR) assays with primers and probes sequences

Genomes for all 19 strains are published on the NCBI website.

Created February 7, 2020, Updated April 26, 2024