FDA approves Cellestis' latent TB (tuberculosis) test:
This article was originally published in Clinica
Executive Summary
The US FDA has approved for sale Cellestis' blood test for latent tuberculosis (TB) infection. The QuantiFERON-TB test is based on the measurement of IFN-gamma secreted from stimulated T cell lymphocytes previously exposed to Mycobacterium tuberculosis infection. The assay involves an overnight culture of whole blood with tuberculin and control antigens, followed by detection of IFN-gamma in a rapid, single-step, sandwich ELISA. The accurate identification of individuals with latent TB infection is crucial to the goal of TB elimination, says the Australian biotechnology firm.