biostudies-literatureUnknown82Cleveland MHNational Institute of Standards and TechnologyIn 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.Biologicals : journal of the International Association of Biological Standardization101680https://www.ebi.ac.uk/biostudies/studies/S-EPMC10154543biostudies-literatureRapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing.PMC10154543Valiant WGVallone PMRomsos ELServetas SLSteffen CROlson NDCleveland MHfalseRapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing.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.2023-01-01T00:00:00Z2023 May2025-04-21T16:39:55.652Z2025-04-05T10:31:58.221ZS-EPMC101545433717855910.1016/j.biologicals.2023.101680