PerkinElmer gets FDA approval for kit to automate TB test

2020 04 23 00 03 7623 Lung General 400

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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