FDA Approves Revvity’s Improved Automated Latent Tuberculosis Test

Revvity has obtained U.S. Food and Drug Administration approval for its Auto-Pure 2400 liquid handling platform with the T-SPOT.TB test.

First launched outside the U.S. in 2024, this combination lets labs improve productivity while keeping superior clinical performance in detecting latent tuberculosis (TB), the company said. The faster high-throughput solution to deliver accurate diagnosis and support timely treatment and containment.

Auto-Pure 2400 integrates liquid handling and magnetic cell isolation technology. It tests up to 24 samples per run, finishing day one of T-SPOT.TB testing in under 3.5 hours with a single mid-run user interaction.

The World Health Organization (WHO) identified T-SPOT.TB as the only ELISPOT-based IGRA. The methodology has an added cell number normalization step to ensure reproducible results, by minimizing the impact of pre-analytical variables found in other IGRAs.

Revvity also said the test has fewer indeterminate results, less need for repeat testing, and consistent performance in patients who are immunocompromised.

“The integration of the Auto-Pure 2400 platform with the T-SPOT.TB test gives laboratories the ability to process latent TB tests at higher volumes without compromising clinical accuracy,” said Yves Dubaquie, senior VP, diagnostics at Revvity. “By automating T-SPOT.TB testing, we are empowering laboratories with increased throughput and reliability, ultimately leading to better patient outcomes.”

In January, the company received FDA 510(k) clearance for EUROIMMUN’s automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone.