MIKROGEN Expands Diagnostic Product Range with T-Track® SARS-CoV-2 Test for Assessing T-cell Mediated Immune Responses
Mikrogen GmbH, a company developing genetically manufactured in vitro diagnostics, today announced the expansion of its product portfolio with the introduction of its T-Track® SARS-CoV-2 test to determine T-cell mediated immune responses.
The new RT-qPCR-based T-Track® assays (T-Track® SARS-CoV-2) detect the mRNA expression of specific marker cytokines, which in addition to the reactivity of memory T-cells also detect the reactivity of in vivo activated effector T-cells, thereby achieving the highest possible sensitivity. The new technology can detect several cytokines simultaneously by PCR with comparative ease and therefore stands out from other available methods for determining T-cell activity.
Promising results suggest that SARS-CoV-2-specific T-cell activity of vaccinated and recovered individuals differs markedly from that of non-vaccinated and previously uninfected individuals. Compared to current methods, the new T-Track® assays require less sample material (3 ml heparin blood/patient), are more user-friendly (possibility of partial automation and intermediate storage of samples) and already have a high sensitivity in the early infection phase.
With its T-Track® ELISpot Basic products, Mikrogen currently offers the functional detection of antigen-specific T-cells in the ELISpot format. T-cells activated by infection or vaccination can be reactivated in isolated PBMCs (Peripheral Blood Mononuclear Cells) using recombinant proteins (e.g., SARS-CoV-2 proteins NP and S1) and subsequently secrete IFNg (Figure 1A), which can be detected and quantified by a color reaction.
The successful use of the T-Track® ELISpot Basic MTP in the analysis of specific T-cell functionality of healthy individuals, acute COVID-19 sufferers and convalescents has already been published in early 2021 (1).
The products of Mikrogen´s technology platforms can be used, among others, to investigate the following questions:
- Is there a correlation between antibody response and reactivity of SARS-CoV-2-specific T-cells? For example, can patients with a proven history of SARS-CoV-2 infection and low to absent antibody titers have a good T-cell response and thereby possess immune protection?
- Is there a possible protective T-cell-mediated immune response, e.g. against variants of SARS-CoV-2? For instance, is the T-cell response intensity comparable among groups infected with different SARS-CoV-2 variants?
- How does a cell-mediated immune response correlate with disease severity? Measurement of the intensity and kinetics of the cell-mediated immune response in different groups.
- How long does a protective immune response persist after vaccination or disease? Monitoring the strength of the T-cell response after vaccination or disease over time. Is booster vaccination necessary and if so, from when and for whom?
Mikrogen´s T-Track® ELISpot Basic products are now available as Research Use Only (RUO) products. The RT-qPCR based T-Track® SARS-CoV-2 will soon be made available as a Research Use Only (RUO) product, CE-IVD marking is planned in 2022.
About Sars-CoV-2 Diagnostics
After more than one and a half years of the SARS-CoV-2 pandemic, many details about the pathogen and the course of COVID-19 are now known. However, many questions remain unanswered with regard to effective treatment and sustained immunity after disease or vaccination with the different vaccines available. It is considered certain that the immune system responds to infection or vaccination by two different mechanisms. Both mediate immunity against SARS-CoV-2 to a degree and duration that cannot yet be concretely determined. On the one hand, protection against severe disease is mediated by neutralizing antibodies produced by B cells that prevent the virus from entering the body cell. On the other hand, T-lymphocytes are activated by contact with the virus or parts thereof as they are presented during vaccination (2). This stimulates a cascade of further immune responses that may also provide protection against severe COVID-19 courses.
Until now, the focus of diagnostic detection of immunity against viral or bacterial pathogens has undoubtedly been on the serological detection of antibodies. MIKROGEN provides a broad portfolio of tests for this purpose (www.mikrogen.de). Recent studies on SARS-CoV-2 show that T-cell reactivity and thus also the T-cell-mediated immune response against SARS-CoV-2 can in some cases be detected longer than the formation of neutralizing antibodies (2). This brings T-cell diagnostics much stronger in focus.
Mikrogen develops, manufactures and markets system solutions for medical laboratory diagnostics focusing on bacterial, viral or pathogen-induced infections and autoimmune diseases.
Moreover, the Company produces high-quality antigens for medical diagnostics and is a leading provider for test based on recombinant antigens.
Mikrogen is using several technology platforms and, accordingly, offers a broad product portfolio. In addition to a large selection of PCR tests, Mikrogen provides serological tests based on the following platforms: ELISA, ImmunoLine/Blot, as well as Luminex®-based tests and protein microarrays. In 2021, the T-Track® tests for the detection of T-cell reactivity expanded the product portfolio even further.
Mikrogen´s strong product expertise and long-standing experience of its 160 employees are the key success factors of the Company, which was founded in 1989 and is based in Neuried/ Munich.
- Bonifacius A, Tischer-Zimmermann S, Dragon AC, Gussarow D, Vogel A, Krettek U, Gödecke N, Yilmaz M, Kraft ARM, Hoeper MM, Pink I, Schmidt JJ, Li Y, Welte T, Maecker-Kolhoff B, Martens J, Berger MM, Lobenwein C, Stankov MV, Cornberg M, David S, Behrens GMN, Witzke O, Blasczyk R, Eiz-Vesper COVID-19 immune signatures reveal stable antiviral T-cell function despite declining humoral responses. 2021 Feb 9;54(2):340-354.e6. doi: 10.1016/j.immuni.2021.01.008.
- Sette A, Crotty S. Adaptive immunity to SARS-CoV-2 and COVID-19. Cell. 2021;184(4):861-80.