Programmatic Impact of Implementing GeneXpert MTB/ RIF Assay for the Detection of Mycobacterium Tuberculosis in Respiratory Specimens from Pulmonary Tuberculosis Suspected Patients in Resource Limited Laboratory Settings of Eastern Nepal

BACKGROUND: In Nepal, introduction of GeneXpert MTB/RIF assay (Xpert assay) as an initial confirmation test for tuberculosis (TB) has been considered to have impact as a significant decrease in number of clinically diagnosed pulmonary tuberculosis (PTB) cases than previous years. This study aims to find out the distribution profile of suspected tuberculosis cases according to patients age, gender, treatment history and HIV status as well as to evaluate the utility of the Xpert assay over conventional acid-fast bacilli (AFB) staining method for the proper diagnosis of M. Tuberculosis in respiratory specimens from the tuberculosis (TB) suspected patient samples. METHODS: The prospective cross-sectional analytical study was conducted in National Anti-Tuberculosis Center (NATA) center- Biratnagar and Primary Healthcare Center (PHC) - Manglabare, Morang District, of eastern Nepal from January 2014 to August 2014. Laboratory investigation was done by conventional AFB staining followed by Xpert assay. RESULTS: A total of 1549 sputum samples were initially analyzed. AFB staining resulted in 1441 AFB smear negative samples and 88 AFB smear positive samples, whereas 20 samples were directly processed for Xpert assay. The male: female smear positive ratio was 2.8:1 and was higher among age groups (21-40) years. Tuberculosis among HIV patients was found 22.22%. Xpert assay demonstrates that out of 1441 smear negative AFB cases, 258 were found to have TB positive, whereas out of 88 smears positive AFB cases 12 were found to have TB negative. The sensitivity of the Xpert assay in patients classified as AFB smear positive was found 85.4% and the specificity in smear negative patients was 81%. CONCLUSION: The study concluded that implementation of Gene Xpert MTB/RIF assay is a helpful tool for early and rapid detection of tuberculosis with greater sensitivity and specificity over traditional AFB staining techniques.