FDA approves T-Cell Select to automate TB testing

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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.