The US Food and Drug Administration (FDA) has granted approval for Revvity’s Auto-Pure 2400 liquid handling platform, used in conjunction with the T-SPOT.TB test.
This approval introduces an enhancement in latent tuberculosis (TB) detection, offering a “high-throughput” solution that delivers timely diagnostic outcomes.
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The combination was launched last year outside the US.
The Auto-Pure 2400 system integrates magnetic cell isolation and liquid handling technology and streamlines laboratory workflows by testing up to 24 samples for each run.
It completes the first day of T-SPOT.TB testing in less than three and a half hours, requiring minimal user interaction.
The World Health Organization (WHO) recognises the test as the “only” enzyme-linked immunospot (ELISPOT)-based interferon-gamma release assay (IGRA), notable for its cell number “normalisation” step that guarantees reproducible outcomes.
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By GlobalDataAccording to the company, T-SPOT.TB, which identifies latent tuberculosis infection (LTBI), is said to include a reduced rate of indeterminate outcomes and minimal requirement for repeat testing.
The WHO has recently acknowledged the test’s methodology, which includes the washing, isolating and counting of peripheral blood mononuclear cells (PBMCs) before performing the test.
Transitioning from traditional whole blood sample testing, the test offers “reliability and precision” in TB infection testing.
Revvity diagnostics senior vice-president Yves Dubaquie said: “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.
“By automating T-SPOT.TB testing, we are empowering laboratories with increased throughput and reliability, ultimately leading to better patient outcomes.”
Revvity caters to a diverse clientele, including pharmaceutical and biotech entities, governments, diagnostic laboratories, and academia.
It offers diagnostic solutions, biomarker discovery, imaging, informatics, translational multi-omics and screening.
Earlier this year, the company secured FDA clearance for its automated chemiluminescence-based immunoassay (ChLIA) test for free testosterone.
