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# FDA Approves QuantiFeron-TB Plus Diagnostic
- URL: https://www.fdaweb.com/fda-approves-quantiferon-tb-plus-diagnostic/
- Published: 2019-11-27T12:00:00.000Z
- Updated: 2026-09-14T15:54:43.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145604

FDA has approved a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus (QFT-Plus), a fourth-generation test for latent tuberculosis (TB) detection on DiaSorin’s Liaison platforms. The companies say the QFT-Plus offers streamlined laboratory automation for TB screening, and supports the “conversion from tuberculin skin tests to modern blood-based QuantiFERON technology.” The device has been available in Europe since 9/2018.

The companies say that the QFT-Plus test uses a peptide cocktail simulating *M. tuberculosis* proteins to stimulate cells in heparinized whole blood. “Detection of interferon-γ (IFN-γ) by enzyme-linked immunosorbent assay (ELISA) is used to identify in vitro responses to these peptide antigens that are associated with *Mycobacterium tuberculosis* infection,” they say.