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.
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