PerkinElmer gets FDA approval for kit to automate TB test

By staff writers

September 22, 2022 -- PerkinElmer’s Oxford Immunotec business on Thursday announced that the U.S. Food and Drug Administration (FDA) has approved the use of T-Cell Select reagent kit for the automation of its T-Spot.TB test workflow for in vitro diagnostic (IVD) use by certified laboratories.

The reagent kit allows for a more automated workflow and is designed to reduce hands-on time for lab personnel and lower overall costs, the firm said.

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 and simplify the preparation of cells for the T-Spot.TB test, a globally regulated enzyme-linked immunosorbent spot (ELISPOT) interferon gamma release assay (IGRA) for detecting latent TB infection.

"Automation closes the gap between ELISPOT and ELISA [enzyme-linked immunoassay] laboratory workflows, enabling more laboratories to offer the ... T-Spot.TB test to more physicians," Phill Keefe, CEO of PerkinElmer's Oxford Immunotec division, said in a statement.

PerkinElmer added that the kits are available throughout Europe in countries that accept CE marking; South Korea, through its Ministry of Food and Drug Safety; and China, through its National Medical Products Administration (NMPA).

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Last Updated mp 9/22/2022 11:40:00 AM

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