In the early days of the COVID-19 pandemic, diagnostic testing was challenging. The tests were inaccurate, resulting in false results for both laboratory-developed and commercially-developed assays. This hampered efforts to identify cases quickly and contain the spread of the virus. The lack of reliable reference materials was a significant factor in these early diagnostic failures. Clinical testing labs were desperately searching for quality solutions that could help them independently verify that their assays were working properly. Learn how we successfully addressed these challenges:

As an RNA virus, SARS-CoV-2's genome replication is innately error-prone such that mutations are expected (1). Every now and then, a mutation will provide an adaptive advantage (such as increased transmissibility or infectivity to a human host), and will be positively selected for in the population. This process drives viral genome evolution, and gives rise to the rich diversity of viral strains and lineages that we see. However, for SARS-CoV-2, the unexpected emergence of such diversity since late 2020 has led to considerable anxiety around the progression of disease, and the efficacy of diagnostics and vaccines to control its spread.