Patho-TB test for the rapid diagnosis of pulmonary tuberculosis

BACKGROUND: Despite recent technologic improvements in identifying mycobacterium tuberculosis, we are still facing problems in rapid diagnosis of tuberculosis. The objective of this study is to determine the diagnostic value of a new rapid screening test (Patho-TB™) for diagnosis of pulmonary tuberculosis. METHODS: Between September 2006 to August 2007, 178 patients were enrolled in the study who were finally classified into two groups; a group of documented pulmonary tuberculosis (n = 67) and a group of non-tuberculous pulmonary infection (n = 111). Patho-TB™ test, Ziehl-Neelsen staining and culture were done on all specimens. RESULTS: Of all, 43 patients with pulmonary tuberculosis were sputum smear positive for acid fast bacilli and the rest were smear negative. Mean age of the patients was 59.8 ± 16.1 years and 44% of them were men. The results of Patho-TB™ test were positive in 40 of smear positive and 20 of smear negative tuberculous patients and 33 cases of non-tuberculous control group. The sensitivity, specificity, positive and negative predictive values and accuracy of Patho-TB™ test were estimated 89.5%, 70.2%, 64.5%, 91.7% and 77.5%, respectively. CONCLUSIONS: According to the present study it would be suggested that Patho-TB™ test could be a rapid and inexpensive method for diagnosis of pulmonary tuberculosis, given by its high sensitivity and negative predictive value. Concerning the high number of false positive results, using a confirmatory diagnostic procedure is mandatory.