Rapid Molecular Detection of Mycobacterium Tuberculosis (MTB) inPulmonary and Extrapulmonary Samples.

Project Name:- Rapid Molecular Detection of Mycobacterium Tuberculosis (MTB) in Pulmonary and Extrapulmonary Samples

Project Officer:-

1. Principal Investigator:- Dr. Sumit Kumar Vishwakarma, Ramnath Prasad Institute of Higher Education Foundation East Champaran (Bihar).

2. Co-PI: Dr. Sandeep Dogra, Professor & HOD, Department of Microbiology, Govt. Medical College & Hospital Jammu (J&K).

3. Research Scholar:- Dr. Sheeta Sharma, Scholar, Ramnath Prasad Institute of Higher Education Foundation East Champaran (Bihar).

Co-Worker:-

Mr. Abhinash Kumar

Mrs. Antima Singh

Implementing NGO: RPIHE Foundation

Project Location: Rajouri District, Jammu & Kashmir (J&K)

Project Duration:- 10 Months

Project Cost: 66000

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1. Project Rationale

Tuberculosis (TB) is a major global health challenge, causing an estimated 1.5 million deaths in 2020 alone. The global public health response has been complicated by difficulties in diagnosing patients and linking them to care. The COVID-19 pandemic further exacerbated the problem, with the number of undiagnosed and unreported TB cases increasing to over 4 million in 2020. India has the highest incidence of tuberculosis in the world, with approximately 2.8 million cases annually.

Traditional diagnostic methods, like smear microscopy, often lack the sensitivity to detect all cases, particularly extrapulmonary tuberculosis (EPTB) and cases with low bacterial loads. Rapid, accurate molecular tests are crucial for timely diagnosis and for identifying drug-resistant strains. This project aims to address this gap by deploying a rapid molecular diagnostic system in a rural setting.

2. Project Objectives

The project, conducted over a ten-month period from May 2024 to February 2025, aimed to:

• To establish and operate a rapid molecular diagnostic facility using TrueNat technology for the detection of MTB in both pulmonary and extrapulmonary samples.

  
  

• To conduct a study to assess the rate of inconclusive TrueNat results and determine their root causes in a real-world setting.

  
  

• To improve the timely diagnosis of TB and reduce the number of undiagnosed cases by providing a more sensitive and rapid diagnostic method than traditional smear microscopy.

  
  

3. Material and Methods

This project was a retrospective study conducted by the Department of Microbiology, Government Medical College, Rajouri, in collaboration with the District Tuberculosis Centre, Rajouri, J&K.

• Study Population and Sample Collection: A total of 248 samples were collected over a ten-month period from May 2024 to February 2025. The samples came from patients with symptoms suggestive of pulmonary TB and also included extrapulmonary samples. Patients with symptoms such as a cough lasting more than two weeks, hemoptysis, fever, weight loss, and night sweats were included. Samples resembling saliva or blood-stained samples were excluded.

  
  

• Diagnostic Technology: The study utilized the TrueNat rapid PCR system. The TrueNat MTB assay is a chip-based, real-time PCR test that can detect MTB and rifampicin drug resistance using portable, battery-operated devices. It has been extensively evaluated and compared with other molecular diagnostic methods. The project's use of TrueNat aligns with the World Health Organization's (WHO) endorsement of TrueNat PCR as a rapid diagnostic test for TB, particularly for drug-resistant TB, pediatric TB, and EPTB.

  
  

• Data Collection: Patient details such as name, age, gender, address, and referring center were recorded. A total of 248 samples were collected, with a near-equal distribution of males (50.8%) and females (49.2%).

  
  

4. Project Outcomes and Findings

• Positive Cases: Out of the 248 samples tested, 44 (17%) were positive for MTB by TrueNat. This demonstrates the effectiveness of the rapid molecular test in identifying cases.

  
  

• Symptomology: The most common symptoms among the study population were cough (46.3%) and fever (35.8%).

  
  

• Demographics: The largest group of suspected EPTB patients was in the 50-59 and 60-69 age categories. The majority of TB cases were found in the 60-69 age group, with a male predominance.

  
  

• Diagnostic Superiority: The study highlighted the usefulness of the TrueNat over and above the traditional smear microscopy for significantly higher positive results.

  
  

5. Conclusion and Future Recommendations

The project successfully demonstrated that in resource-limited rural settings, where establishing sophisticated laboratories for culture is difficult, the TrueNat PCR system provides a very effective detection method. This indigenous, economical, and convenient tool facilitates early treatment decisions and helps to curb the transmission of tuberculosis. The study concludes that the use of TrueNat contributes to the 'End TB' strategy by providing a rapid, accurate diagnostic method with the added advantage of detecting multidrug-resistant cases.