Utility of Line Probe Assay for the Early Detection of Multidrug-Resistant Pulmonary Tuberculosis.

Abstract

Background:Despite endorsement of the line probe assay (LPA) for the diagnosis of drug-resistant pulmonary tuberculosis patients, there is limited data available on the performance of LPAs in India, especially from high burden states like Maharashtra, for the early diagnosis and detection of drug resistance, in order to initiate timely and appropriate treatment.Objective:To evaluate the utility of the line probe assay (LPA) for the early diagnosis of drug-resistant pulmonary tuberculosis as compared to the ‘Gold standard’ 1% proportion method (PM).Materials and Methods:A total of 687 patients suspected of pulmonary tuberculosis were screened. One hundred samples (95 sputum and 5 BAL), positive for Acid Fast Bacilli (AFB) by Ziehl Neelson (ZN) smears, were included in the study. Digested and decontaminated specimens were subjected directly to the LPA (Genotype MTBDR@ plus assay) and were processed in parallel using the conventional culture on the Lowenstein-Jensen (LJ) medium followed by drug susceptibility testing (DST) using the PM.Results:All the 100 samples gave interpretable results on LPA with a turnaround time of 24-48 hours as opposed to six to eight weeks taken by the 1% proportion method. Sensitivity for the detection of rifampicin, isoniazid, and multidrug resistance (MDR) was 98.1, 92.1, and 95%, respectively, with a specificity of 97.8% for rifampicin and 98.33% for MDR detection. It also had the additional advantage of allowing a study of mutation patterns.Conclusions:High performance characteristics and a short turnaround time makes LPA an excellent diagnostic tool, for an early and accurate diagnosis, in a high MDR- TB-prevalent region, as reflected from our data.