Abstract
Tuberculosis (TB) is one of the major communicable diseases around the world and an estimated 9 million people were diagnosed based on the report from World Health Organization (WHO). With 12,338 new cases and 626 TB-related deaths in 2012, TB remains the highest incidence and mortality rate among all airborne contagious diseases in Taiwan. Conventional methods, sputum acid-fast bacilli (AFB) smear microscopy and culture of TB bacteria on liquid or solid media, can be inaccurate and time-consuming. The study aimed to determine the accuracy of the GeneXpert MTB/RIF system, a commercially available nucleic acid amplification technology, in diagnosing TB. A total of 1641 samples were collected in a medical center from January 2016 to December 2017. Lowenstein-Jensen (L-J) solid medium, Mycobacterium Growth Indicator Tube (MGIT), and GeneXpert MTB/RIF assay were performed to identify Mycobacteria. Additionally, culture based conventional drug susceptibility test (DST) was administered to measure the efficacy of this molecular method. The sensitivity and specificity of the GeneXpert MTB/RIF were90.1% (128/142) and 98.1% (1471/1499) respectively. The negative predictive value (NPV) was 99.1% (1471/1485) and positive predictive value (PPV) was 82.1% (128/156). The MTB/RIF assay also detected 1 rifampicin resistant specimen from the 1641 cases, and the results were confirmed by drug susceptibility testing. Besides, the turnaround time for TB confirmation test decreased from 2-3 weeks to 2-3 hours in this microbiology laboratory. In conclusion, the GeneXpert MTB/RIF system exhibits high sensitivity and specificity for detecting tuberculosis and has the potential to apply to other human infectious pathogens. The study shows that the laboratory requires an efficient and accurate tool for identifying communicable disease. Timely confirmation of communicable diseases can lead to earlier treatment for the suspected individual, decrease the chance of transmission in the clinical settings, and provide more effective public health interventions.
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