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

Biologicals. 2023 May:82:101680. doi: 10.1016/j.biologicals.2023.101680. Epub 2023 May 3.


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.

Keywords: Diagnostics; Digital PCR; Reference materials; SARS-CoV-2.

MeSH terms

  • COVID-19 Testing
  • COVID-19* / diagnosis
  • Humans
  • Molecular Diagnostic Techniques / methods
  • Pandemics
  • RNA, Viral / genetics
  • SARS-CoV-2* / genetics
  • Sensitivity and Specificity


  • RNA, Viral