NEW YORK — PerkinElmer subsidiary Oxford Immunotec said Thursday it gained US Food and Drug Administration approval for its T-Cell Select reagent kit that automates sample preparation steps for its tuberculosis in vitro diagnostic assay.
The kit reduces the hands-on work and cost of the firm's T-SPOT.TB interferon-gamma release TB screening test, the company said. It also improves blood sample logistics by allowing use of standard blood collection tubes and storage of samples at room temperatures for up to 54 hours.
The kit uses a peripheral blood mononuclear cell isolation reagent with magnetic bead-based cell separation during sample preparation. PerkinElmer said its T-SPOT test and T-Cell Select reagent kit are, together, the only automated interferon-gamma release assay sold without a label warning about use on samples from immunocompromised patients who have diminished T-cell levels.
By increasing the stability of blood samples, the kit also helps labs centralize sample processing, expand access to the assay, and take advantage of opportunities for sample batching, Oxford Immunotec said.
PerkinElmer bought Oxford Immunotec in 2021 and has since worked to build out the company's latent TB testing business and develop its T-cell testing projects. Oxford Immunotec had filed for FDA approval of the T-Cell Select reagent kit before the sale, and the kit was already available in Europe with CE marking.