QIAGEN  announced the launch of its QuantiFERON-EBV RUO (Research Use Only) assay. Epstein-Barr virus (EBV), or human herpes virus 4, is estimated in various epidemiological studies to be positive in more than 90% of the world’s population and is a significant pathogen in organ transplant recipients.

This new addition to the QuantiFERON portfolio of assays is designed to support research into EBV infection and EBV-related malignancies by utilizing highly specific EBV antigens to stimulate a cell-mediated immune response, offering a dynamic view of the host’s active immune engagement with the virus.

EBV is involved in diseases ranging from infectious mononucleosis to EBV-related tumors and tumor-like lesions. In organ transplant recipients, EBV is associated with post-transplant lymphoproliferative disorder (PTLD), a potentially fatal complication after solid organ transplantation. Over 80% of PTLD cases in Europe and the U.S. are estimated to be EBV-associated.[1]

Additionally, a growing body of evidence suggests a potential connection between EBV and multiple sclerosis (MS), a chronic disease of the central nervous system estimated to affect more than 2.8 million people worldwide. EBV T-cell measurement in MS might have a potential role in understanding disease progression, treatment monitoring and developing tailored therapeutic approaches.[2]

“The QuantiFERON-EBV RUO assay represents a significant advancement in our understanding of the complex relationship between EBV and the immune system,” said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “This assay opens doors to innovative research, offering insights that can revolutionize patient care by guiding tailored treatment across various medical fields, including oncology and autoimmune disease.”

T-cells play a crucial role in controlling and eliminating viruses, with an effective T-cell response helping determine the course and severity of an EBV infection. Measuring the T-cell response to EBV can help researchers better understand immune responses to the virus. Specifically, in transplant patients, it has the potential to personalize immune suppressive treatment, stratify the risk of EBV-induced disease, assist clinicians in customizing the timing of testing and monitoring, and evaluate the efficiency and durability of future EBV vaccines.

QuantiFERON-EBV RUO uses a combination of CD4+ and CD8+ antigens specific to EBV nuclear antigen proteins, to stimulate lymphocytes in heparinized whole blood. This approach is different from but complementary to traditional tests, which focus on detecting viral DNA or antibodies produced in response to the virus.

Growing portfolio of QuantiFERON cell-mediated immune response tests

The new assay adds to the growing QuantiFERON portfolio of cell-mediated immune response tests. QuantiFERON-TB Gold Plus is the world’s leading IGRA blood test, with millions of tuberculosis tests performed annually. QuantiFERON SARS-CoV-2 identifies immune responses to COVID-19, while QuantiFERON-CMV is an indirect test for cytomegalovirus infections in transplant patients. QuantiFERON Monitor evaluates nonpathogen-specific cell-mediated immune responses in transplant patients. Furthermore, QIAGEN and DiaSorin collaboratively developed the LIAISON LymeDetect test, which utilizes QuantiFERON technology to detect early Lyme Borreliosis infections. [3]

QIAGEN’s QuantiFERON technology is a unique method for detecting cell-mediated immune responses from whole blood samples. It works by identifying specific T-cells in individuals with infectious agent exposure. When an infection-specific antigen is combined with the blood, rapid re-stimulation of antigen-specific T-cells occurs, leading to the secretion of interferon-gamma (IFN-γ), which can be measured as a marker of an immune response. The tests include QuantiFERON blood collection tubes with their proprietary stimulation principle and the QuantiFERON ELISA detection system to measure the resulting interferon-gamma.