Qiagen has obtained CE mark for its QuantiFeron SARS-CoV-2 assay, which can assess T-cell responses to Covid-19.
Developed using the company’s QuantiFERON interferon gamma release technology, the SARS-CoV-2 assay is designed to detect interferon-γ (IFN-γ) produced by CD4+ and CD8+ T cells in response to a SARS-CoV-2 peptide cocktail in the blood.
The new in vitro diagnostic test has the ability to detect T-cell responses to Covid-19 early in the course of infection or after vaccination.
Qiagen noted that serology tests that measure antibodies in people after vaccination, often generate positive test results but cannot assess cellular responses.
T-cell detection can provide vital insights into the immune response to a SARS-CoV-2 infection in individuals, which is beyond serology alone.
The new CE mark-granted test from Qiagen can also assess cell-mediated immunity in individuals who have been vaccinated.
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Qiagen molecular diagnostics business area head and senior vice-president Jean-Pascal Viola said: “T-cells provide valuable insights into our immune system’s response to Covid-19.
“The more we know about this epidemic, the better equipped the world will be to address this threat that will stay with us.”
The company stated that T-cell response to the virus decreases slowly when compared to the antibody response.
The response helps to indicate how severe the illness triggered by SARS-CoV-2 will be in Covid-19 patients.
It also helps to find the immunity levels in recovered patients.
Furthermore, the new QuantiFERON SARS-CoV-2 assay should be used in combination with other laboratory testing and epidemiological/clinical evaluation.
Recently, the company’s Liaison QuantiFeron-TB Gold Plus assay received approval from the US Food and Drug Administration (FDA) for use on DiaSorin‘s Liaison XS platform.