Xpert MTB/RIF TB test: Pivotal trial data

Researchers at the FIND (Foundation for Innovative New Diagnostics) and colleagues reported data from an international pivotal trial in 1,730 patients with suspected drug-sensitive or multidrug-resistant pulmonary TB showing that Cepheid's Xpert MTB/RIF assay had 98.2% sensitivity for patients with smear-positive, culture-positive TB and 99.2% specificity for patients without TB. The test also had 97.6% sensitivity for patients with rifampin-resistant bacteria and 98.1% sensitivity for patients with rifampin-sensitive bacteria. Data were published in the New England Journal of Medicine. Cepheid plans to start an additional pivotal trial of the assay next year. ...