On Sept. 29, 2020, Oxford Immunotec announced that it had received clearance from the U.S. Food and Drug Administration (FDA) to amend the pediatric age limitation to allow use of the T-SPOT.TB test in individuals two years of age and older.

The T-SPOT.TB test is a single-visit blood test for TB screening and is one of only two recommended alternatives to the tuberculin skin test (TST) – otherwise known as purified protein derivative (PPD) test, or the Mantoux test. The T-SPOT.TB test is available in over 50 countries including Europe, China, Japan and the US, and is recognized by the WHO as one of the 100 essential diagnostic tests that should be available in every country. The T-SPOT.TB test uses a standardized sample, reducing the influence of factors in the blood which may affect performance, and normalizing for cell number variation.

The test has been shown to have a sensitivity of 95.6% and a specificity in excess of 97.1%, and is able to maintain performance even in samples otherwise difficult to test, such as samples from immunosuppressed patients. The T-SPOT.TB test does not cross-react with the BCG vaccine. Automation of the T-SPOT.TB test is possible using the T-Cell Select™ reagent kit. Automation solutions are available for low, medium and high throughput settings. The T-Cell Select reagent kit also enables samples to be stored at ambient temperature for up to 54 hours after blood is collected.