1. Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing.
- Author
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Cleveland MH, Romsos EL, Steffen CR, Olson ND, Servetas SL, Valiant WG, and Vallone PM
- Subjects
- Humans, Pandemics, Molecular Diagnostic Techniques methods, RNA, Viral genetics, Sensitivity and Specificity, COVID-19 Testing, SARS-CoV-2 genetics, COVID-19 diagnosis
- 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., (Published by Elsevier Ltd.)
- Published
- 2023
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