FDA approves T-Cell Select to automate TB testing

October 2022—Oxford Immunotec, a division of Perkin­Elmer, announced FDA approval of its T-Cell Select reagent kit for automating the company’s T-Spot.TB test workflow for in vitro diagnostic use by certified laboratories.

T-Cell Select is a peripheral blood mononuclear cell (PBMC) isolation reagent that uses positive selection of PBMCs with magnetic bead­–based cell separation to automate the preparation of cells for the T-Spot.TB test, a globally regulated ELISpot IGRA for detecting latent TB infection. Samples can be stored at room temperature for up to 54 hours. The company says its T-Spot.TB test with the T-Cell Select reagent kit is the only automated IGRA TB test without regulatory warnings for immunocompromised patients.

The kit is available in Europe where the CE mark is accepted and in South Korea and China.

Oxford Immunotec, 508-481-4648