Rapid Diagnosis of Extrapulmonary Tuberculosis by Ligase Chain Reaction Amplification
Abstract
Rapid Diagnosis of Extrapulmonary Tuberculosis by Ligase Chain Reaction Amplification Fredy Gamboa 1 , 2 , José Dominguez 1 , Eduardo Padilla 1 , José M. Manterola 1 , 3 , Elena Gazapo 4 , Joan Lonca 1 , Lurdes Matas 1 , 3 , Agueda Hernandez 1 , Pere Joan Cardona 1 , and Vicente Ausina 1 , 3 , * Servicio de Microbiologı́a, Hospital Universitario Germans Trias i Pujol, 1 and Departamento de Genética y Microbiologı́a, Facultad de Medicina, Universidad Autónoma de Barcelona, 3 Barcelona and Abbott Cientı́fica S.A., Madrid, 4 Spain, and Departamento de Microbiologı́a, Facultad de Ciencias, Pontificia Universidad Javeriana, Bogotá, Colombia 2 ABSTRACT A rapid amplification-based test for the diagnosis of extrapulmonary tuberculosis, the LCx Mycobacterium tuberculosis Assay from Abbott Laboratories, was evaluated. Results from the LCx M. tuberculosis Assay were compared with those from culture and the final clinical diagnosis for each patient. A total of 526 nonrespiratory specimens from 492 patients were tested. The specimens included urine; feces; lymph node exudates; pleural, cerebrospinal, articular, and ascitic fluids; tissue biopsies; gastric aspirates; purulent exudates; blood; and bone marrow aspirates. After combination of the culture results and the patient’s clinical data, a total of 135 specimens were collected from 122 patients with a diagnosis of extrapulmonary tuberculosis. The sensitivity, specificity, and positive and negative predictive values for the LCx M. tuberculosis Assay were 77.7, 98.7, 95.2, and 93.1%, respectively; these values rose in resolved cases of TB to 78.5, 100, 100, and 93.1%, respectively. For 37 (27.4%) specimens from patients smear positive for the disease and 98 (72.6%) specimens from patients smear negative for the disease, the sensitivities of the LCx M. tuberculosis Assay were 100 and 71.1%, respectively. Statistically significant differences ( P < 0.01) in sensitivities were found between culture and the LCx M. tuberculosis Assay. These differences were even greater among smear-negative specimens. The results demonstrate that the LCx M. tuberculosis Assay will provide rapid and valuable information for the diagnosis of extrapulmonary tuberculosis.