Rapid Production and Free Distribution of a Synthetic RNA Material to Support SARS-CoV-2 Molecular Diagnostic Testing
Megan Cleveland, Erica Romsos, Becky Steffen, Nathanael David Olson, Stephanie Servetas, William Valiant, Peter Vallone
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.
, Romsos, E.
, Steffen, B.
, Olson, N.
, Servetas, S.
, Valiant, W.
and Vallone, P.
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 December 1, 2023)