Rapid Production and Free Distribution of a Synthetic RNA Material to Support SARS-CoV-2 Molecular Diagnostic Testing

Published

May 3, 2023

Author(s)

Megan Cleveland, Erica Romsos, Becky Steffen, Nathanael David Olson, Stephanie Servetas, William Valiant, Peter Vallone

Abstract

In response to the COVID-19 pandemic, the National Institute of Standards and Technology released a synthetic RNA material for SARS-CoV-2 in June 2020. The goal was to rapidly produce a material to support molecular diagnostic testing applications. This material referred to as Research Grade Test Material 10169, was shipped free of charge to laboratories across the globe to provide a non-hazardous material for assay development and assay calibration. The material consisted of two unique regions of the SARS-CoV-2 genome approximately 4 kb nucleotides in length. The concentration of each synthetic fragment was measured using RT-dPCR methods and confirmed to be compatible with RT-qPCR methods. In this report, the preparation, stability, and limitations of this material are described.

Citation

Biologicals

Pub Type

Journals

Download Paper

https://doi.org/10.1016/j.biologicals.2023.101680

Local Download

Keywords

SARS-Cov-2, COVID-19, pandemic, RNA, reference materials, research grade test material, RGTM

Citation

Cleveland, M. , Romsos, E. , Steffen, B. , Olson, N. , Servetas, S. , Valiant, W. and Vallone, P. (2023), Rapid Production and Free Distribution of a Synthetic RNA Material to Support SARS-CoV-2 Molecular Diagnostic Testing, Biologicals, [online], https://doi.org/10.1016/j.biologicals.2023.101680, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=936098 (Accessed October 9, 2025)