Revvity receives FDA approval for automated latent tuberculosis test
GRevvity, Inc. has secured US Food and Drug Administration approval for its Auto-Pure 2400 liquid handling platform with the T-SPOT.TB test, enhancing laboratory capabilities for latent tuberculosis detection. The technology, already available outside the US since 2024, enables higher testing volumes whilst maintaining clinical accuracy in this critical infectious disease diagnostic area.
Key technological advancements
The Auto-Pure 2400 system represents a significant leap forward in latent TB testing efficiency. It seamlessly integrates liquid handling and magnetic cell isolation technology, allowing laboratories to process up to 24 samples per run. The system completes the first day of T-SPOT.TB testing in under 3.5 hours with minimal user interaction, streamlining laboratory workflows.
“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 vice president, diagnostics at Revvity. “By automating T-SPOT.TB testing, we are empowering laboratories with increased throughput and reliability, ultimately leading to better patient outcomes.”
Clinical advantages
The World Health Organization identifies T-SPOT.TB as the only ELISPOT-based interferon-gamma release assay (IGRA). This methodology incorporates a cell number normalisation step that ensures reproducible results by minimising the impact of pre-analytical variables commonly seen in other IGRAs.
The test offers significant clinical benefits, including fewer indeterminate results, reduced need for repeat testing, and consistent performance in immunocompromised patients—populations that often present diagnostic challenges with other testing methods.
Global impact
This FDA approval marks a crucial advancement in tuberculosis control efforts. The high-throughput capabilities of the Auto-Pure 2400 platform enable more efficient delivery of accurate diagnostic results, supporting timely treatment and containment strategies both in the US and globally.
The technology was initially launched outside the US in 2024 and has now received regulatory clearance for the American market. Revvity notes that products may not be licensed in accordance with laws in all countries, and customers should check with local representatives for availability.
For more information, visit: www.revvity.com
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