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Qiagen Obtains CE Mark for Assay Measuring T-Cell Response to SARS-CoV-2

NEW YORK ─ Qiagen said Thursday it has obtained CE marking for its QuantiFeron SARS-CoV-2 assay, which measures T-cell responses to SARS-CoV-2 and aids in the assessment of immunity in individuals who have received COVID-19 vaccination.

The Hilden, Germany-based firm said its assay, based on its QuantiFeron interferon gamma release assay (IGRA) technology, detects CD4+ and CD8+ T-cell responses.

Though serology tests that measure antibodies in people following vaccination can generate positive test results, they are unable to assess cellular responses, Qiagen noted. T-cell detection can contribute insights into the immune response to a SARS-CoV-2 infection that go beyond what serology testing alone can provide, the firm said, adding that its newly CE marked test can detect T-cell response early in a COVID-19 infection or following vaccination.

Qiagen has leveraged its IGRA technology for tuberculosis tests that employ whole blood and do not require the purification of lymphocytes for T-cell measurement. In October, the firm announced it had obtained CE marking for its QiaReach QuantiFeron-TB point-of-care test based on the technology.