Oxford Immunotec Showcases Automated T-SPOT.TB Test at MEDICA 2022

The company has manufactured in excess of 20 million clinical T cell tests for TB infection, and its T-SPOT.TB test has been approved for sale in over 50 countries. 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. As a result, the T-SPOT.TB test is now automated using the T-Cell Select reagent kit which provides a simplified workflow while maintaining the same superior clinical performance expected from the T-SPOT.TB test. The T-Cell Select reagent kit simplifies the T-SPOT.TB test laboratory workflow through automation, expanding access to the most sensitive latent TB test on the market.

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 test, 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 of the T-SPOT.TB test has been shown to reduce hands-on time as much as 50% in European laboratories, depending on what components of the modular system are used. 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.

“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.

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PerkinElmer, Inc.
Oxford Immunotec