PerkinElmer's Oxford Immunotec Receives U.S. FDA Approval for T-Cell Select to Automate Clinically Superior Tuberculosis Detection
PerkinElmer's (NYSE: PKI) Oxford Immunotec today announced the U.S. Food and Drug Administration (FDA) has approved the use of the 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 T-Cell Select reagent kit allows for a more automated workflow, designed to reduce hands-on time for lab personnel and lower overall costs. The increased use of automation also improves blood sample logistics, as it allows for a standard blood collection tube which can be stored at room temperature for up to 54 hours with no complex phlebotomy practices. The extended blood sample stability enables easy centralization of sample processing, which expands access to the T-SPOT.TB test and gives laboratories more flexibility with the potential for sample batching.
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 tes, a globally regulated ELISPOT IGRA for detecting latent TB infection. The T-SPOT.TB test with the T-Cell Select reagent kit is the only automated IGRA TB test without regulatory (label) warnings for immunocompromised patients, who often have lower levels of T cells available to evaluate.
"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," said Phill Keefe, chief executive officer of PerkinElmer's Oxford Immunotec division. "This results in the highest quality of care for the most vulnerable patients across the United States."
The T-Cell Select reagent kit is available throughout Europe where CE marking is accepted, South Korea by the Ministry of Food and Drug Safety, China by the National Medical Products Administration (NMPA) and is quickly becoming available in more markets around the world.
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