Tuberculosis has over 10 million cases in the world and over 1.3 million deaths associated with it each year, tuberculosis (TB) is one of the most serious infectious diseases in the world. Mycobacterium tuberculosis complex (MTBC) which is a group of closely related species that can infect both humans and animals causes Tuberculosis. TB mainly affects the lungs (pulmonary TB) but it can also result in Extrapulmonary disease which affects other organs like the kidneys, brain, spine and the lymphatic system. Today, TB remains a significant global health concern despite the advancements in diagnosis and treatment. India bears almost 25% of the total TB burden of the world.

According to Global Tuberculosis Report 2025 published by WHO.

·         10.7 million new cases of tuberculosis were reported worldwide in 2024.

·         1.23 million TB deaths globally in 2024.

·         390K cases of MDR (Multi-Drug-resistant TB) were detected in 2024.

·         150K MDR deaths estimated in 2024.

Resistance to both isoniazid and rifampicin is known as Multidrug-Resistant Tuberculosis (MDR-TB), and it has become a significant global public health issue. Poor drug quality, ongoing transmission within communities and inadequate or ineffective treatment are the main causes. Over 410,000 cases of MDR or rifampicin-resistant tuberculosis (MDR/RR-TB) are reported globally each year, which complicates disease management and highlights the need for better diagnostics and efficient treatment approaches.

Breaking the Cycle: Stopping the Spread of Tuberculosis

A comprehensive strategy is needed to prevent tuberculosis. AS MTB is spread through respiratory droplets, good ventilation and airflow in homes, workplaces and healthcare facilities help prevent its spread. In clinical settings the most crucial points are using personal protective equipment and early isolation of suspected cases. Contact tracing and screening of those who have been exposed is also very important. Addressing undernutrition and cutting back on alcohol and tobacco use also strengthens prevention.

Why Molecular Leads Go Beyond the Smear

For more than a century, sputum smear microscopy and mycobacterial culture have been used to diagnose tuberculosis (TB), but they have serious drawbacks. Up to 55% of active TB cases are missed by smear microscopy, especially in cases of paucibacillary disease. The gold standard, culture, can take two to eight weeks, which prolongs the window of community transmission and delays therapy.
This is completely altered by real-time PCR. In just three to five hours, a single molecular run can identify MTBC, identify resistance mutations and verify sample quality. One extracted sample, one run and a comprehensive clinical response is the power of the syndromic molecular panel. For individuals with compromised immune systems, paediatric cases or extrapulmonary.

Molecular testing is the diagnosis for tuberculosis (TB), where bacterial loads are low and smear sensitivity collapses. Prevention is also fuelled by early detection: each confirmed MDR-TB case found quickly results in fewer days of undetected transmission, quicker contact tracing and a smaller resistant cluster that communities can contain.

Breaking Barriers in Tuberculosis Diagnostics with Cutting-Edge PCR

Together, the two complementary, CE-IVD marked molecular assays provided by 3B BlackBio Dx Ltd. cover the entire TB diagnostic pathway, from drug resistance profiling to detection.

TRUPCR® MTBC One Step Nested Kit

The TRUPCR® MTBC One Step Nested Kit is designed for the rapid detection of the Mycobacterium tuberculosis complex (MTBC) from a variety of clinical specimens, including sputum, bronchoalveolar lavage (BAL), cerebrospinal fluid (CSF), pus, tissue and blood. The assay demonstrates a high analytical sensitivity with a limit of detection of ≥10 CFU/mL for MTBC. It also includes a built-in internal control to detect PCR inhibition in each run, ensuring reliable results. The method was validated using 181 clinical samples with Mycobacteria culture serving as the reference standard.

✓ 97.41% Sensitivity
✓ 98.46% Specificity

TRUPCR® RIF/INH MTB Drug Resistance Detection Kit

The TRUPCR® RIF/INH MTB Drug Resistance Detection Kit goes a step further. Once it detects MTBC, it quickly determines whether the strain is susceptible or resistant to rifampicin and isoniazid. These two drugs are the most important first-line treatments for TB. The kit uses a nested real-time PCR method. It targets the key genomic areas that cause drug resistance in M. tuberculosis. This approach provides a clear result in terms of resistance or susceptibility in a single run. The limit of detection for both rifampicin and isoniazid resistance is 120 CFU/mL.

ü  100% RIF Sensitivity

ü  100% INH Sensitivity

ü  100% MDR Specificity

These advances show how integrated molecular diagnostics are changing tuberculosis management. They enable faster detection, precise differentiation and early identification of drug resistance. These factors are essential for effective disease control.

Publications

·         Sethi V, Raghuvanshi S, Kotwal A, et al. (September 03, 2022) Multidrug-Resistant Musculoskeletal Tuberculosis: An Aggressive Clinical, Radiological and Molecular Confirmation with Genotypic Drug Susceptibility Testing Approach. Cureus 14(9): e28720. doi:10.7759/cureus.28720

·         Isolation of Mycobacterium monacense from chemoport: A rare case report and review of literature (R. Dandamudi, L. Nambaru, & S. J. Rajappa, Trans.). (2017). Indian Journal of Case Reports, 3(2), 74-76.

·         Isoniazid Resistance Level and Associated Resistance Conferring-mutations in Rifampicin Resistant Mycobacteriumtuberculosis. (Naomee Shareef1, Shaheda Anwar2, Abu Naser Ibne Sattar2, ASM Rayahanul Hoque3, Mohammad Jobayer4, Ahmed Abu Saleh2). Bangladesh Medical Res Counc Bull 2023; 49: 120-125