Diagnosis and treatment of pulmonary tuberculosis in one day: Way forward for END TB Strategy 2015.

Abstract

According to Revised National Tuberculosis Control Program (RNTCP), diagnosis of pulmonary tuberculosis (TB) in India requires examination of two sputum samples collected over 2 days, that is, "spot" and next day "morning" samples. To assess the feasibility of diagnosing pulmonary TB by examining two spot sputum samples in 1 day and to compare this approach with the current RNTCP protocol. A total of 375 subjects having cough >2 weeks were enrolled into the study. Three sputum samples were collected from each of the study participant; first spot (S1), second extra-spot (S2) sample 1 h after collection of the first sample, and third morning (M) sample collected next day morning. These specimens were subjected to standard sputum smear microscopy for acid-fast bacilli as per RNTCP guidelines. For 1-day protocol, results of "S1 and S2" samples and for 2-day protocol results of "S1 and M" samples were considered. The number of sputum-positive pulmonary TB cases diagnosed with standard 2-day protocol was 119, whereas the experimental 1-day protocol diagnosed 120 cases (<i>P</i> = 0.7). Comparing with standard 2-day protocol, this new 1-day protocol had sensitivity 98.32%, specificity 100%, positive predictive value 100%, and negative predictive value 99.17%. Single-day method can be adopted as the standard diagnostic approach for pulmonary TB after large-scale multicenter randomized controlled trials.