The Study on the Effectiveness of Detecting Drug Resistance to Rifampicin and Isoniazid in M. tuberculosis Using Real-time PCR with the SANITY 2.0 Machine

Abstract

          Tuberculosis is an infectious disease that poses a significant public health challenge, especially the problem of drug-resistant tuberculosis, particularly resistance to rifampicin (RIF) and isoniazid (INH), which are the primary drugs for treatment. Bamrasnaradura Infectious Diseases Institute has implemented molecular testing using an automated machine with the MTB/MDR test kit (Sanity 2.0) to compare with the Line Probe Assay (LPA) method, which is recommended by the World Health Organization, to evaluate the effectiveness of detecting tuberculosis and RIF and INH resistant tuberculosis in 50 tuberculosis patient samples. For tuberculosis detection results, the MTB/MDR test kit (Sanity 2.0) and LPA showed concordant results: 5 samples were negative and 45 samples were positive for TB, representing sensitivity, specificity, and accuracy of 100%. For drug resistance detection, the results showed that samples susceptible to both drugs matched in 25 samples (55.6%), samples resistant to only RIF matched in 1 sample (2.2%), samples resistant to only INH matched in 8 samples (17.8%), and samples resistant to both RIF and INH matched in 10 samples (22.2%). There was a discordant result in 1 sample (2.2%), where the LPA method showed resistance to INH only, while the MTB/MDR test kit (Sanity 2.0) showed resistance to both drugs. Analysis using the Kappa coefficient (K) for RIF and INH resistance results yielded values of 0.94 and 1.00 respectively, indicating excellent agreement between the two testing methods. When considering the waiting time aspect, it was found that the MTB/MDR test kit (Sanity 2.0) requires less time but costs more than testing with the LPA method. From this study, it can be concluded that testing with the MTB/MDR test kit (SANITY 2.0) can be used for molecular biological analysis, which will expedite patient identification, allowing patients to receive immediate treatment.