Evaluation of GeneXpert MTB/RIF assay for direct diagnosis of pulmonary tuberculosis.

OBJECTIVES: To evaluate the performance of GeneXpert MTB/RIF assay for direct diagnosis of pulmonary tuberculosis (PTB).   METHODS: This is a cross-sectional study conducted between October 2013 and February 2016 at Abbassaia Chest Hospital and Ain Shams University Hospital, Cairo, Egypt. Inclusion criteria were adults between 18 and 60 years with suspected PTB and classified into 5 clinical categories based on their clinical, radiological, and laboratory findings:  confirmed TB, probable TB, possible TB, unlikely TB, and not TB. Two sputum samples from each participant were analyzed by GX and the results were compared by conventional culture. RESULTS: In total, 218 participants were enrolled: 71 had confirmed TB; 112, highly probable TB; 20, probable TB; 10, unlikely TB; and 5, no TB. The sensitivity and specificity of the GX assay were 93% and 98.3% respectively. GeneXpert was positive in 93% of confirmed TB and 2.2% of probable TB cases.  CONCLUSIONS: GeneXpert is a rapid and promising technique with good sensitivity (93%) and specificity (98.3%), but it cannot be used as a standalone PTB diagnostic tool. There is a need for more GX evaluation studies in countries with low TB incidence.