FDA approves Oxford Immunotec’s T-Cell Select to use with T-Spot.TB test

Oxford Immunotec, a Perkin Elmer company, received FDA approval to use T-Cell Select with its in vitro diagnostics tuberculosis (TB) detection test, T-SPOT.TB test.

A T-SPOT.TB test detects a latent TB infection and works by the following steps:

1. A blood sample collection and isolation of the peripheral blood mononuclear cells (PBMCs) – preparation step.
2. Addition of Mycobacterium tuberculosis antigens to activate the cells.
3. The capture of the Interferon-gamma released by the antigen-activated cells.
4. Detection of the complex using an enzyme-based immunoassay.

The new addition – the T-cell Select reagent kit – automates and simplifies the blood sample preparation step of the T-SPOT.TB test. It can isolate PBMCs in a few simple steps using antibodies and magnetic beads, which can then be stored for up to 54 hours at room temperature. Due to this extended storage capability, the T-cell Select reagent kit improves overall blood sample logistics, including flexibility for sample batching, ease in extending the sample delivery, and increased access to laboratories.

“Automation closes the gap between ELISPOT and ELISA laboratory workflows, enabling more laboratories to offer the clinically superior T-SPOT.TB test to more physicians,” Phill Keefe, chief executive officer of PerkinElmer’s Oxford Immunotec division, said in a statement. “This results in the highest quality of care for the most vulnerable patients across the United States.”

T-cell Select obtained CE Mark approval in 2018 and is also available to use in South Korea and China.