QuantiFERON SARS-CoV-2 RUO

As T cells are becoming increasingly recognized for their role in SARS-CoV-2 infection and immunity, the exploration of immune response markers in COVID-19 infections is becoming the next tool for researching potential improvements in patient management and vaccination guidance (10–12).

QIAGEN is widely committed in the fight against COVID-19 and you can now count on the world-leading QuantiFERON IGRA technology to support your research toward fighting this pandemic.

The QuantiFERON SARS-CoV-2 Blood Collection Tubes and QuantiFERON ELISA are for Research Use Only and not for diagnostic use.

The QuantiFERON SARS-CoV-2 Blood Collection Tubes and QuantiFERON ELISA are for Research Use Only and not for diagnostic use. Performances have not been established yet.

You decide to work with what matters most for your research: the QuantiFERON SARS-CoV-2 RUO solution is composed of several components that can be ordered separately or combined to provide better research insights on patients’ immune status.

The QuantiFERON SARS-CoV-2 RUO solution is an original combination of blood collection tubes containing innovative specific peptides formulated to stimulate lymphocytes in heparinized whole blood involved in cell-mediated immunity. Plasma from the stimulated samples can then be used for detection of IFN-γ using a simple ELISA.

The QuantiFERON Control Set Blood Collection Tubes (QFN Control BCTs) consist of the QuantiFERON Nil and QuantiFERON Mitogen BCTs. The QFN Control BCT workflow includes blood collection and processing to generate plasma for the detection of IFN-γ. QFN Nil and Mitogen BCTs are intended to be used as negative and positive controls in conjunction with other QuantiFERON Antigen Tubes, when workflow and donor controls are required.

The QuantiFERON SARS-CoV-2 Starter Set (QFN SARS-CoV-2) Blood Collection Tube is for Research Use Only and uses a combination of antigens specific to SARS-CoV-2 to stimulate lymphocytes in heparinized whole blood involved in cell-mediated immunity. Plasma from the stimulated samples can be used for detection of cytokines, including IFN-γ. Detection of IFN-γ can be measured using QuantiFERON ELISA. The QFN SARS-CoV-2 Blood Collection Tubes are not for use in diagnostic procedures.

The QuantiFERON Monitor Direct (QFM Direct) Blood Collection Tube uses a combination of antigens to stimulate lymphocytes in heparinized whole blood involved in cell-mediated immunity. Plasma from the stimulated samples can be used for detection of IFN-γ, which can be done using QuantiFERON ELISA. The QFM Direct BCT is for Research Use Only and not for diagnostic use.

The QuantiFERON ELISA (QFN ELISA) is a microplate coated with specific material for determining the concentration of IFN-γ in a human plasma sample (reported in International Units per ml; IU/ml). Analysis of results is performed using the QuantiFERON Software.

Numerous publications and recent research highlight the potential applications of immune response assays in COVID-19 infections, such as, but not limited to:

• Investigating infection severity in hospitalized COVID-19 patients
• Investigating patient prognosis in ICU
• Investigating cell-mediated immune (CMI) response following SARS-CoV-2 natural infection and/or COVID-19 vaccination

Analysis software for QuantiFERON SARS-CoV-2 RUO is available for download.

References

Research publications indicating the use of T cell assays in severity assessment and monitoring of individuals

1. Rydyznski Moderbacher, C. et al., (2020) Antigens-specific adaptive immunity to SARS-CoV-2 in acute COVID-19 and associations with age and disease severity. Cell 183, 1–17.

2. Candon, S. et al., (2020) T cell and antibody responses to SARS-CoV-2: experience from a French transplantation and hemodialysis center during the COVID-19 pandemic. Am J Transplant doi:10.1111/ajt.16348

3. Han, M. et al., (2020) Assessing SARS-CoV-2 RNA levels and lymphocyte/T cell counts in COVID-19 patients revealed initial immune status as a major determinant of disease severity. Med Microbiol Immunol 209, 657–668.

4. Iqbal, H. (2020) The importance of cell-mediated immunity in COVID-19 – An opinion. Medical Hypotheses 143, 110152.

5. Liu, B. et al., (2020) Reduced numbers of T cells and B cells correlates with persistent SARS-CoV-2 presence in non-severe COVID-19 patients. Sci Rep 10, 17718.

6. Petrone, L. et al., (2020) A whole blood test to measure SARS-CoV-2 specific response in COVID-19 patients. Clin Microbiol Infect https://doi.org/10.1016/j.cmi.2020.09.051

7. Stephens, D.S. and McElrath, M.J. (2020) COVID-19 and the path to immunity. JAMA 324 (13), 1279–1281.

8. Zhang, B., Yue, D., Wang, Y., Wang, F., Wu, S. and Hou, H. (2020) The dynamics of immune response in COVID‐19 patients with different illness severity. J Med Virol https://doi.org/10.1002/jmv.26504.

9. Poonia, B. and Kottilil, S. (2020) Immune correlates of COVID-19 control. Front Immunol 11, 569611. doi: 10.3389/fimmu.2020.569611

Research publications indicating the use of T cell assays in vaccine efficacy, epidemiology survey and protective immunity assessment

10. Grifoni, A. et al., (2020) Targets of T cell responses to SARS-CoV-2 coronavirus in humans with COVID-19 disease and unexposed individuals. Cell 181, 1489–1501.

11. Murugesan, K. et al., (2020) Interferon-gamma release assay for accurate detection of SARS-CoV-2 T cell response. Clin Infect Dis, ciaa1537, https://doi.org/10.1093/cid/ciaa1537

12. Sauer, K. and Harris, T. (2020) An Effective COVID-19 vaccine needs to engage T cells. Front Immunol 11, 2371.

13 Oladipo, E.K. et al., (2020) Exploration of surface glycoprotein to design multi-epitope vaccine for the prevention of Covid-19. Inform Med Unlocked 21, 100438, https://doi.org/10.1016/j.imu.2020.100438

14. Cox, R.J. and Brokstad, K.A. (2020) Not just antibodies: B cells and T cells mediate immunity to COVID-19. Nat Rev Immunol 20, 581–582.

15. Mateus, J. et al., (2020) Selective and cross-reactive SARS-CoV-2 T cell epitopes in unexposed humans. Science 370 (6512), 89–94.

16. de Vries, R.D. (2020) SARS-CoV-2-specific T-cells in unexposed humans: presence of cross-reactive memory cells does not equal protective immunity. Sig Transduct Target Ther 5, 224.

17. Peng, Y. et al., (2020) Broad and strong memory CD4+ and CD8+ T cells induced by SARS-CoV-2 in UK convalescent individuals following COVID-19. Nat Immunol 21, 1336–1345.

18. Petrone, L., et al., (2020) A whole blood test to measure SARS-CoV-2 specific response in COVID-19 patients. Clin Microbiol Infect https://doi.org/10.1016/j.cmi.2020.09.051.

19. Weiskopf, D. et al., (2020) Phenotype and kinetics of SARS-CoV-2-specific T-cells in COVID-19 patients with acute respiratory distress syndrome. Sci Immunol 5 (48), doi: 10.1126/sciimmunol.abd2071

20. Sekine, T. et al., (2020) Robust T cell immunity in convalescent individuals with asymptomatic or mild COVID-19. Cell 183 (1), 158–168 E14.