ARTICLE | Clinical News

Xpert MTB/RIF TB test: Pivotal trial data

May 2, 2011 7:00 AM UTC

Researchers at the FIND (Foundation for Innovative New Diagnostics) and colleagues reported data from an international pivotal trial in 6,648 patients with suspected TB or multidrug-resistant TB showing that Cepheid's Xpert MTB/RIF TB assay detected 90.3% of culture-confirmed cases of TB compared to 67.1% for microscopy (p<0.0001). Xpert MTB/RIF had 76.9% sensitivity for detecting patients with smear-negative, culture-positive TB and 99% specificity for detecting patients without TB. The test also had 94.4% sensitivity and 98.3% specificity for patients with rifampin-resistant bacteria. Compared to microscopy, co-infection with HIV did not significantly reduce the sensitivity of the Xpert MTB/RIF assay. Data were published in The Lancet. ...