T-SPOT®.TB Gains FDA Premarket Approval

The FDA has approved a premarket approval application for the T-SPOT.TB test from Oxford Immunotec.

The T-SPOT.TB test is a laboratory based cellular blood test that is intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection and disease. T-SPOT.TB improves accuracy and eliminates the logistical challenges found with the current tuberculin skin test.

The T-SPOT.TB test has been tested in patient groups indicated for screening for TB infection according to current American Thoracic Society and Center for Disease Control Guidance; such as, HIV positive persons, recent contacts of TB case patients, patients with chronic renal failure, children, and immunosuppressed patients.

T-SPOT.TB is the only blood test that has demonstrated in a pivotal clinical study both sensitivity and specificity exceeding ninety-five percent and reliability in all targeted patient groups.