Abstract
Background: The most practical test for identifying tuberculosis (TB) in developing countries remains smear microscopy. However, due to its low sensitivity, a new point-of-care diagnostic method has been developed. The purpose of this study was to assess the performance of TB-Loop-mediated isothermal amplification (TB-LAMP) test on sputum samples of suspected TB cases. Methods: Suspected pulmonary TB patients (527) from Jamot Hospital and without any history of anti-TB treatment were consecutively included in the study. Smear microscopy, TB-LAMP, GeneXpert® MTB/RIF, and liquid culture using BACTEC 960 Mycobacteria Growth Indicator Tube (MGIT) were performed on sputum samples collected from these patients. The sensitivity and specificity of TB-LAMP were compared with smear microscopy and GeneXpert® MTB/RIF. MGIT culture was the gold standard. Results: TB-LAMP and smear microscopy showed sensitivities of 82.6% (95% confidence interval [CI], 76.9–87.2) and 53.6% (95% CI, 46.8–60.3), respectively, and specificities of 96.0% (95% CI, 93.2–97.7) and 99.0% (95% CI, 97.1–99.7), respectively. The sensitivity and specificity of TB-LAMP were similar to GeneXpert®, (89.9%; 95% CI, 85.0–93.3 and 97.0%; 95% CI, 94.4–98.4). Conclusion: TB-LAMP is more sensitive than currently used microscopy. It presents a favorable diagnostic tool for TB in peripheral laboratories with limited equipment, such as those in developing countries.
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