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Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing.


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.

SUBMITTER: Cleveland MH 

PROVIDER: S-EPMC10154543 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing.

Cleveland Megan H MH   Romsos Erica L EL   Steffen Carolyn R CR   Olson Nathan D ND   Servetas Stephanie L SL   Valiant William G WG   Vallone Peter M PM  

Biologicals : journal of the International Association of Biological Standardization 20230503


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  ...[more]

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