The newly U.S. Food and Drug Administration–approved automated latent tuberculosis test (Auto-Pure 2400 platform) was capable of completing the first day of T-SPOT.TB testing in under 3.5 hours and required only one midrun user interaction, according to the manufacturer.

The U.S. Food and Drug Administration (FDA) approved Revvity’s novel liquid handling platform for use with the T-SPOT.TB test, enabling automated detection of latent tuberculosis (TB) in clinical laboratories, according to a press release from Revvity. Initially launched outside the United States in 2024, the integrated system is intended to support high-throughput testing while maintaining diagnostic accuracy.

According to Revvity, the automated latent TB test was designed to streamline laboratory workflows by combining liquid handling with magnetic cell isolation technology. The system can process up to 24 samples per run. The company noted that this approach may improve efficiency without compromising clinical performance.

The T-SPOT.TB assay is the only enzyme-linked immunospot-based interferon-gamma release assay identified by the World Health Organization. It includes a cell number normalization step designed to minimize the impact of preanalytical variability and improve reproducibility. The test has been associated with fewer indeterminate results, reduced repeat testing, and consistent performance in immunocompromised patients.

Yves Dubaquie, Senior Vice President of Diagnostics at Revvity, stated that automation of the T-SPOT.TB test may enhance laboratory throughput and reliability, supporting timely latent TB diagnosis and treatment.

The system is intended for in vitro diagnostic use. Product availability may vary by country based on local regulatory requirements.