COVOO | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, Varies

Useful for detection of COVID-19 due to SARS-CoV-2

SARS-CoV-2 variants still detected by SARS-CoV-2 polymerase chain reaction tests

COFLU | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA and Influenza Virus Type A and Type B RNA Detection, PCR, Varies

Detection and differentiation of coronavirus disease 2019 (COVID-19) illness (due to SARS-CoV-2) and influenza A and B viral infection in a single test using upper respiratory tract specimens

COVNG | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Lineage, Clade, and Spike Gene Mutation Detection by Next-Generation Sequencing, Varies

Please note that Mayo Clinic Laboratories is now offering a SARS-CoV-2 sequencing test to:

• Distinguish between persistent infection and re-infection in individuals with recurrent positive molecular test results for SARS-CoV-2
• Detect and identify vaccine-escape SARS-CoV-2 variants with spike (S) gene mutations of interest
• Detect and identify SARS-CoV-2 variants containing S gene mutations of interest that reduce the efficacy of vaccine-induced antibodies, convalescent plasma, or monoclonal antibody therapy for COVID-19

SCOFR   | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA, Influenza Virus Type A and Type B RNA, and Respiratory Syncytial Virus (RSV) RNA Detection by PCR, Varies

RSVQL  | Respiratory Syncytial Virus, RNA, Qualitative Detection, Varies

COVSQ | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Spike Antibody, Semi-Quantitative, Serum

This test provides semi-quantitative detection of serum antibodies against the spike glycoprotein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection and/or vaccination. Useful for the manufacturing of SARS-CoV-2 convalescent plasma units.

COVTA | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), Total Antibody, Serum

This assay detects antibodies against the nucleocapsid protein, which would only be positive following natural infection. This helps determine whether an individual has been infected naturally at some point in time in the past.

SCOVT | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), RNA Detection, ddPCR, Tissue

Detection of severe respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19) in formalin-fixed, paraffin-embedded tissue.

IL6 | Interleukin 6, Plasma

Severe COVID-19 patients are characterized by a higher baseline IL-6 level compared to non-severe infections. In critically ill patients with COVID-19, IL-6 levels were almost tenfold higher. While it is not clear whether elevation in IL-6 has a causal association with pro-inflammatory damage of the lungs or is just a consequence of the lung infection, attempts at blocking IL-6 by using monoclonal antibodies directed against IL-6 receptors have garnered interest as a potential therapeutic option.

TBBS | Quantitative Lymphocyte Subsets: T, B, and Natural Killer (NK), Blood

One of the most characteristic changes in COVID-19 patients is lymphopenia. In addition to total lymphocytes, T cells (CD4+ T cells, CD8+ T cells), B cells, and NK cells are all decreased in COVID-19 patients compared to healthy controls. These cell counts correlate with severity and also normalize in post-treatment patients who recover. For severe cases of COVID-19, further analysis may be required and experts in Mayo Clinic’s Cellular and Molecular Immunology Laboratory are available for further discussion.

TCZ | Tocilizumab Quantitation, Serum

Tocilizumab (TOC) is a recombinant humanized IgG1 kappa monoclonal antibody that targets the IL-6 receptor to block the pro-inflammatory effects of IL-6 mediated signaling. IL-6 is also a critical component of cytokine release syndrome (CRS), which results from an overactive immune response and can occur in COVID-19 patients. This immunoassay is designed to determine TOC concentrations in human serum.

As noted in the recent Mayo Clinic Proceedings article linked above, during the current COVID-19 outbreak, a cohort of 21 febrile patients received TOC, and this led to defervescence, reduction in supplemental oxygenation, and improvement in clinical symptoms. However, the absence of a control group cautions against the optimistic interpretation of this promising data. Clinical trials are underway to evaluate the efficacy and safety of TOC for IL-6 inhibition in the management of COVID-19.

Additional references for TOC:

• Tanaka T, Narazaki M, Kishimoto T. IL-6 in inflammation, immunity, and disease. Cold Spring Harb Perspect Biol. 2014;6(10):a016295.
• Sheppard M, Laskou F, Stapleton PP, Hadavi S, Dasgupta B. Tocilizumab (Actemra). Hum Vaccin Immunother. 2017;13(9):1972-1988.

CYPAN | Cytokine Panel, Plasma

Cytokines are important mediators of cell-to-cell communication within the innate and adaptive immune systems. The expression of most cytokines is highly regulated, and generally occurs in response to foreign or self-antigenic stimulation. As a group, cytokines and their receptors represent a highly complex and critical regulator of a normal immune response. This immunoassay is designed to help understand the etiology of infectious (viral) or chronic inflammatory diseases, when used in conjunction with clinical information and other laboratory testing.

Additional references for CYPAN:

• Teijara, JR. Type I interferons in viral control and immune regulation. Curr Opin Virol. 2016;16:31-40.
• Tisoncki, JR, Korth, MJ, Simmons, CP, et al. Into the eye of the cytokine storm. Microbiol Mol Biol Rev. 2012;76:16-32.
• Garcia Borrega, J, Godel, P, Ruger, MA, et al. In the eye of the storm: Immune-mediated toxicities associated with CAR-T cell therapy. Hemasphere. 2019;3:e.

DCME | Dendritic Cell and Monocyte Enumeration, Blood

Dendritic cells play a critical role in both innate and adaptive immune responses. Dendritic cells include two major subsets: myeloid (or conventional) dendritic cells (mDC) and plasmacytoid dendritic cells (pDC).

• mDC can capture and present antigens to CD4+ T cells and cross-present them to CD8+ T cells. They are also a source of inflammatory cytokines.
• pDC takes part in priming of anti-viral T cells and is the major source of type I interferons; as such it acts as a primary defense against viremia.

This test enumerates pDC, mDC, and classical monocytes. It can be used as part of the diagnostic assessment of patients suspected of defects in innate immunity, particularly those in monocyte and dendritic cell development, which can manifest in isolation or as part of a broader clinical phenotype. This test has not been validated for the diagnosis of hematologic malignancies.

Additional references for DCME:

• Bigley V, Cytlak U, Collin M. Human dendritic cell immunodeficiencies. Semin Cell Dev Biol. 2019;86:50-61.
• Reizis B. Plasmacytoid Dendritic Cells: Development, Regulation, and Function. Immunity. 2019;50:37-50.
• Vuckovic S, Gardiner D, Field K, Chapman GV, Khalil D, Gill D, et al. Monitoring dendritic cells in clinical practice using a new whole blood single-platform TruCOUNT assay. J Immunol Methods. 2004;284:73-87.