ROLE OF MOLECULAR DIAGNOSTIC TEST IN DIAGNOSING PULMONARY AND EXTRAPULMONARY TUBERCULOSIS
Journal Title: Journal of Evolution of Medical and Dental Sciences - Year 2018, Vol 7, Issue 23
Abstract
BACKGROUND Mycobacterium tuberculosis remains one of the most significant causes of death from an infectious agent. The rapid diagnosis of tuberculosis and detection of Rifampicin resistance are essential for early disease management. The Gene-Xpert MTB/RIF assay is novel integrated diagnostic device for the diagnosis of tuberculosis and rapid detection of RIF resistance in clinical specimens. This study is to assess the role of molecular diagnostic test, the Gene-Xpert in diagnosing Tuberculosis. Aims and Objectives1. Application of newer molecular diagnostic test, Gene-Xpert for the diagnosis of tuberculosis in suspected TB patients. 2. To find out sensitivity and specificity of Gene-Xpert. 3. To find out the incidence of drug resistance in newly detected TB with the help of Gene-Xpert. MATERIALS AND METHODS This is a prospective observational study which was conducted in Government Medical College, Kozhikode. A total of 100 patients were included who met the inclusion criteria. Patients were diagnosed to have TB by AFB culture, smear positivity and also clinically. These diagnosed TB patients were grouped into culture positive and negative, smear positive and negative and GeneXpert positive and negative; sensitivity and specificity of Gene-Xpert in diagnosing pulmonary and extrapulmonary TB was found out. The incidence of drug resistance in newly detected TB was also found out. RESULTS The performance of the Gene-Xpert assay for rapid diagnosis of tuberculosis and detection of Rifampicin resistance in pulmonary and extrapulmonary specimens obtained from possible tuberculosis patients was determined. 100 patients who satisfied the inclusion criteria were selected and 62 pulmonary and 38 extrapulmonary specimens of these patients were studied. 49 (41 culture positive and 8 culture negative for M. tuberculosis) of the 100 patients were diagnosed to have tuberculosis. The sensitivity and specificity of Gene-Xpert was found to be 75.5% and 100% respectively. In pulmonary specimens, sensitivity and specificity were 79.3% and 100% respectively. In extrapulmonary specimens, sensitivity was 70% and specificity was 100%. In smear positive and negative tuberculosis, sensitivity was 100% and 62.5% respevtively. The Gene-Xpert also detected 2 RIF resistant specimens and 35 RIF susceptible specimens. Incidence of RIF resistance in newly detected TB patients was 4.08% (2/49). CONCLUSION Gene-Xpert sensitivity is higher than AFB smear, both in pulmonary and extrapulmonary specimens. Simultaneous detection of Rifampicin resistance is especially beneficial in patient with MDR and HIV associated Tuberculosis. Early detection of TB and RIF resistance helps to initiate the appropriate therapy, thus improving the quality of TB care. However, Gene-Xpert will not replace conventional microscopy, AFB smear, culture and drug sensitivity. So, this test may be done in the context of a comprehensive algorithm including microscopy, AFB smear, culture and drug sensitivity
Authors and Affiliations
Sheela Mathew, Manjunath M. Pradhani, Beena Philomina
Keywords
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- EP ID EP439357
- DOI 10.14260/jemds/2018/627
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