NEW YORK – Revvity said on Wednesday that it has gained US Food and Drug Administration approval for an automated latent tuberculosis test that combines the Allsheng-developed Auto-Pure 2400 liquid handling platform with Revvity's T-SPOT.TB test.
The Waltham, Massachusetts-based firm said that the Auto-Pure 2400 platform is used for liquid handling with magnetic cell isolation technology and has a capacity of 24 samples per run. It said that the test can be used to complete day-one T-SPOT.TB workflows within 3.5 hours. The firm noted that it launched the combination last year in markets outside the US, offering labs improved productivity for latent TB detection.
"By automating T-SPOT.TB testing, we are empowering laboratories with increased throughput and reliability, ultimately leading to better patient outcomes," Yves Dubaquie, senior VP of diagnostics for Revvity, said in a statement.
Revvity, formerly PerkinElmer, has been working since 2021 on the automation of the T-Spot interferon-gamma release assay (IGRA), which it had gained through its $591 million acquisition of Oxford Immunotec. The company said in 2022 that it had received FDA approval for its T-Cell Select reagent kit to automate sample preparation steps for the assay.
Revvity said Wednesday that the World Health Organization has identified the T-SPOT.TB as the only enzyme-linked immunospot (ELISpot)-based IGRA, which the company uses with an added cell number normalization step to minimize pre-analytical variables and offer reproducible results.