SARS-COV-2 Variants Working Group

Membership

A. EXECUTIVE SUMMARY

The emergence of novel SARS-CoV-2 variants of concern such as the new Omicron (B.1.1.529), which possess high and unprecedented mutational profile, represents an urgent new threat to global pandemic response efforts. Due to the large number of mutations across the Omicron genome, there is urgent need for global collaboration to investigate the impact of new variants on the spectrum of SARS-CoV-2 diagnostics and ensure the validity and continuity of COVID-19 testing (molecular, antigenic and serological). Among the new VoCs, Omicron has clearly demonstrated the potential for new lineages with significant antigenic drift to emerge in the coming months and years, and the need establish priorities and actions plans that can be implemented when such variants arise and spread rapidly all around the world. Thus, a SARS-CoV-2 Variants Working Group (WG) within the IFCC Task Force on COVID-19 is being established, focusing on developing the best strategies to address the impact of new variants on laboratory diagnosis and monitoring of COVID-19 infection and disease.

B. SCOPE

The aim of this group is to support the overall mission of IFCC Task Force on COVID-19 by strategizing and addressing urgent issues related to impact of variants of concern on COVID-19 diagnostics. Terms of the reference are as follows:

• Develop global strategies and collaboration amongst clinical laboratories, research laboratories, and industry to address urgent diagnostic issues due to the emergence of variants. Specifically, the work is intended to investigate:
     (a) gene(s) dropout (failure) in molecular assays;
     (b) antigenic tests failure;
     (c) assessing neutralizing potential of antibodies;
     (d) assist and coordinate development/optimization/validation of new anti-SARS-CoV-2 immunoassays with new epitopes/antigens;
     (e) provide assay support for new vaccine development against VOC;
• Provide updates, tentative guidance, and consensus documents to the IFCC Task Force on COVID-19 regarding the impact of variants on diagnostic and serological tests for SARS-CoV-2;
• Address clinical, technical and organizational perspectives on the impact of variants on laboratory-based and POC testing in COVID-19 patients and collaborate with the IFCC Task Force on COVID-19 to provide guidelines/recommendation when feasible;
• Integrate data on the impact of variants on COVID-19 diagnostics and laboratory abnormalities from all over the world, and promote or coordinate new studies on variants;
• Maintain a repository of scientific articles on the impact of variants on laboratory testing for diagnosing, prognosticating and monitoring COVID-19;
• Suggest healthcare policies (e.g., targeted vaccination) to be proactive or more effective to limit the impact on new VoCs on society and healthcare.

C. MANDATE

With the support of the President of the IFCC, the IFCC Executive Committee, and IFCC COVID-19 Taskforce Chair, the IFCC WG on SARS-CoV-2 variants is now established within the IFCC Task Force on COVID-19. The group shall remain active, as needed, to respond to newly emerging variants until the dissipation of the pandemic, or until terminated by the President of the IFCC. The SARS-CoV-2 Variants Working Group will report directly to IFCC COVID-19 Taskforce Chair and to the President of the IFCC.

Chair's Contact

Dr. Brandon M. Henry
The Heart Institute
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229
USA
E-mail: Brandon.Henry@cchmc.org