COVID-19 ECHO Session #38: Impact of Novel Variants on COVID-19 Diagnostics

March 15, 2021

On 5th March 2021, ASLM hosted a special COVID-19 session that looked at COVID-19 genomics surveillance and how mutations can affect diagnostics and Polymerase Chain Reaction (PCR). Genomic surveillance looks at the different sets of primers that are available and check the mutation into the primary targeted or binding sites. Mutations accumulate within the population and don’t bind properly, these can lead to false-negative test results. Professor Christian Happi, a Professor of Molecular Biology and Genomics, ACEGID & Redeemer’s University, Nigeria share surveillance data on genomics between Nigeria and Cameroun and demonstrates the reason why there is a need to continue to do genomic sequencing of COVID-19. These lineages with multiple mutations at key sites in the spike protein decrease neutralization of antibodies. Dr. Jilian Sacks, Head, Pandemic Preparedness at Foundation for Innovative and New Diagnostics (FIND) discusses the impact of novel variants on COVID-19 diagnostics. She discusses how these novel variants B.1.1.7 or 501Y.V1 identified in the United Kingdom (UK), B.1.351 or 501Y.V2 identified in South Africa, and P.1 or 501Y.V3 identified in Brazil have alterations in the viral genome and may affect the sensitivity of both PCR tests and Rapid Diagnostics either antigen or antibody tests. In these regards, the United States Food and Drug Administration (US FDA) has issued guidance on the developers of these assay on how to mitigate against the impact of these variants but also end-users are urged to be aware of the potential effect on certain diagnostic tests and in order to take precautionary measures, do quality Assurance (QA) and monitor test results trends. Devy Emperador, a Scientific Officer, Pandemic Preparedness Unit at FIND shares the guidance developed by FIND and ASLM. The is an overview of the development of new in-house real-time PCR tests for SARS-CoV-2 and a roadmap on the development of new molecular diagnostics on other emerging pathogens. ASLM and FIND through the ASLM academy have organized in-depth training based on this PCR guide which will help participants to develop in-house protocols for use in their laboratories.