Evaluation of a IS6110-Taqman real-time PCR assay to detect Mycobacterium tuberculosis in sputum samples of patients with pulmonary TB

Aim Evaluate the IS6110-Taqman system performance in sputum samples from patients with pulmonary tuberculosis from health services in north-eastern Brazil as a diagnostic laboratory tool for pulmonary tuberculosis. Methods and Results 165 sputum samples from respiratory symptomatic patients were evaluated in the IS6110-TaqMan assay: 66 patients with pulmonary tuberculosis and 99 without TB. When the IS6110-TaqMan assay was evaluated using culture and/or clinical response to the specific treatment as the gold standard, IS6110-TaqMan assay obtained a sensitivity of 87 center dot 9% and specificity of 98%. The performance of IS6110-TaqMan assay was also evaluated with the sputum smear microscopy, resulting in a sensitivity of 79 center dot 7% and specificity 94 center dot 8%. Conclusions The IS6110-TaqMan was rapid, sensitive and specific for the diagnosis of pulmonary TB. Significance and Impact of the Study IS6110-TaqMan assay is a promising auxiliary tool for the diagnosis of pulmonary TB when used in conjunction with routine laboratory tests, clinical and epidemiological criteria of the patient, thus increasing the sensitivity and specificity of diagnosis.