FDA approves rapid tuberculosis diagnostic platform
The U.S. Food and Drug Administration has approved a novel automated latent tuberculosis liquid handling platform, known as Auto-Pure 2400, to be used with the T-SPOT.TB assay.
The T-SPOT.TB assay is a test designed to diagnose latent tuberculosis infections by assessing the quantity of T-lymphocytes that secrete interferon-gamma in response to tuberculosis antigens.
The platform’s manufacturer indicated that the novel system was designed to provide quicker and more accurate diagnostic results in patients experiencing potential tuberculosis symptoms by processing up to 24 tests in 3.5 hours, according to a news report from Pharmacy Times.
The FDA hopes its approval can allow laboratories to process latent tuberculosis tests at higher volumes and minimal user interaction — without sacrificing diagnostic accuracy.
Read more: Pharmacy Times
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