New Diagnostic Patch for Tuberculosis

A new diagnostic for tuberculosis delivers a soluble tuberculosis (TB) protein directly to the skin and can distinguish active TB disease from latent TB infection or prior vaccination.

Called the Transdermal Patch, the test demonstrated a sensitivity of about 88% and a specificity of 100% in late-stage clinical trials. A positive reaction to the test was shown in 43 out of 49 patients with active TB, while no false positives occurred among 28 controls. In contrast, all the controls and active TB patients had positive test results from the Mantoux TB skin test because that test does not distinguish between disease and prior exposure or bacillus camette guerin (BCG) vaccination. Many infants are vaccinated with BCG, so they as well as people with latent TB infection show positive results from the Mantoux skin test.

The trial suggested that the new test might also be useful for monitoring the success of TB chemotherapy, according to Sequella, Inc. (Rockville, MD, USA), which developed the test. A small number of patients successfully treated for TB reverted to a negative test within six months after treatment, although their Mantoux tests remained positive.

"We chose to focus our efforts first on development of an accurate diagnostic for TB because we cannot effectively develop a drug for the treatment of TB without being able to easily and precisely diagnose this disease,” said Carol A. Nacy, CEO of Sequella.




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