Diagnostic contribution of GeneXpert Ultra in pediatric pulmonary tuberculosis

Objectives: To evaluate the contribution of Ultra to the diagnosis of pediatric pulmonary tuberculosis (PTB). Methods: We analyzed prospective data from children and adolescents with presumed PTB whose specimens were tested with Ultra between January 2020 and December 2022. Diagnosis was based on clinical-radiological criteria, clinical response after a two-month treatment period, and microbiological analysis. Ultra was considered positive with a result of 'Detected' and 'Traces' in children under 10 years and in HIV-infected individuals. Fisher's exact test was used for group comparisons, and McNemar's test was used to compare Ultra results with the diagnostic presumption. The study was approved by the Ethics Committee (CAAE No. 02173518.2.0000.5264). Results: A total of 41 patients were included, of whom 63% (26/41) were diagnosed with PTB. Among these, 9/26 (34%) had positive results only through Ultra, with negative AFB and culture. The sensitivity and specificity of Ultra were 50% (13/26) and 100% (15/15), respectively. The PPV was 100% (13/13), and the NPV was 54% (15/28). Of these 28 (68%) patients with negative Ultra results, 13 (46%) were diagnosed with PTB, mostly by MoH-SS. Considering culture as the reference, the PPV and NPV were 67% and 100%, respectively. Conclusions: Ultra significantly contributed to the diagnosis of pediatric PTB, proving to be a promising tool for paucibacillary forms of the disease. However, it should not be used alone. Integrating laboratory tests with clinical evaluation is essential to improving diagnostic accuracy and the management of pediatric TB.