Evaluation of GeneXpert Ultra for Diagnosing Tubercular Pleural Effusion: Diagnostic Accuracy Study (Code-T0116)

Introduction: Tubercular pleural effusion (TPE) is a major cause of pleural effusion in tuberculosis-endemic regions. Diagnosing TPE remains challenging due to nonspecific clinical features and the limitations of conventional diagnostic methods. GeneXpert Ultra, a newer molecular diagnostic tool, has shown promise in detecting Mycobacterium tuberculosis (MTB) DNA with high sensitivity and specificity. This study evaluates the diagnostic accuracy of GeneXpert Ultra in the diagnosis of tubercular pleural effusion.

Aims and Objectives:

Primary Objective

• To study the role of GeneXpert Ultra in diagnosis of tubercular pleural effusion in suspected cases of Tubercular pleural effusion.

Secondary Objective

• To compare the diagnostic efficacy of GeneXpert Ultra in TB pleural effusion with a composite reference standard (CRS)
• To compare the diagnostic efficacy of GeneXpert Ultra in TB pleural effusion with GeneXpert.

Methods: A total of 100 patients with suspected pleural effusion were enrolled in this prospective study. Pleural fluid samples were collected and tested using GeneXpert Ultra, smear microscopy, culture, and histopathology. The sensitivity, specificity, positive predictive value, and negative predictive value of GeneXpert Ultra were calculated and compared with the reference standard of culture and histopathology.

Results: GeneXpert Ultra demonstrated high sensitivity (89%) and specificity (94%) for diagnosing tubercular pleural effusion. The positive predictive value was 92%, and the negative predictive value was 90%. In comparison, smear microscopy showed lower sensitivity, and culture had a longer turnaround time.

Conclusion: GeneXpert Ultra is a highly accurate, rapid diagnostic tool for diagnosing tubercular pleural effusion and can be a valuable alternative to conventional methods, especially in resource-limited settings.

Keywords: GeneXpert Ultra, Tubercular Pleural Effusion, Diagnostic Accuracy, Mycobacterium Tuberculosis, Pleural Fluid, Molecular Diagnostics.