The COVID-19 pandemic continues to have a grip on worldwide health and global economics. Advancing molecular diagnostics is central to the diagnosis and prevention efforts surrounding the deadly SARS-CoV-2 virus. The first presentation is by Marc Salit, Founding Director of The Joint Initiative for Metrology in Biology, Stanford University and leader of the Coronavirus Standards Working Group. CSWG is an international consortium of clinical labs, national measurement labs, IVD manufacturers and IVD organizations. Marc will discuss CSWG efforts to develop tools that ensure the accuracy and reliability of the vital COVID-19 testing enterprise. The second presentation is by Russell Garlick, PhD, CSO at LGC SeraCare. Russell will discuss the emerging need and development of tools for quantitative SARS-CoV-2 viral load testing.

Learning objectives for Russell Garlick’s presentation:

1. To review and understand the technical features of qualitative and quantitative SARS-CoV-2 RT-PCR assays

2. To review clinical applications of SARS-CoV-2 viral load testing for COVID-19 patient management

Learning objectives for Marc Salit’s presentation:

1. To recognize clinical molecular SARS-CoV-2 testing as a measurement process with bias and variability at each process element

2. To learn how control materials and calibration can manage bias and variability through the measurement process