GUJARAT'S 1st TB LABORATORY

Research Projects

No Titles and Scope of Project Sponsoring Agency if any
01 Development and evaluation of rapid, low cost and affordable TB diagnostics. 2017-2020.

Scope: TB Diagnosis (Traditional) - (Sputum examination, culture of sputum or other body fluid, the tuberculin skin test and radiology) are either insensitive or time consuming.

Point of care user friendly: easy interpretation
Cost effective: affordable (USD 1 compared to USD11 for Xpert)
More rapid: 20 minutes compared to 8 to 12 weeks for routine culture
Test can be performed in the clinic & rural settings
Not requires refrigeration for storage, transport

Objectives:
a. Development of lateral flow assay for detection of TB antigen from sputum and other body fluids.
b. Development of lateral flow urine strip test for detection of TB antigen in HIV-co-Infected TB patients.
c. Development of Pocket device for semi-quantitative detection of TB antigen in urine.
d. Development of TB Rapid Tests: IgA and IgG/IgM in tears and plasma (with higher sensitivity & specificity).
e. Test for distinguishing latent TB infection from active TB disease.
f. Scale up of developed tests in IIT Bombay or nearby region.
g. Field evaluation of all developed tests in India and international testing sites.

Budget: ₹2.30 Crore
IMPRINT INDIA [MHFW & MHRD]
[2.30 Crore]
02 Evaluation of molecular platform for drug resistant TB 2015-2017.

Genedrive is a nucleic acid amplification test available on the market for tuberculosis diagnosis. In this study, the clinical sensitivity was substantially lower than that of sputum smear microscopy. An analytical study revealed cross-reactivity with some other mycobacteria and biosafety concerns.

Background: The Epistem Genedrive assay rapidly detects Mycobacterium tuberculosis complex from sputum and is currently available for clinical use.

Methods:
• Analytical limit of detection (LOD) tested with genomic DNA.
• Complete system tested by spiking M. tuberculosis cells into water and negative sputum.
• Specificity checked using respiratory pathogens & non-TB mycobacteria.
• Clinical evaluation used Xpert MTB/RIF assay and culture as reference.
Epistein – UK
03 Development of molecular POCT for diagnosis of TB and HPV.

This POCT is based on RPA (recombinase polymerase amplification) for detection of TB, HPV, Malaria, Dengue etc.

HPV Assay:
• Detects genome DNA of HPV 16 & HPV 18
• Sample: Cervical swab
• For POCT use – clinics, camps, outpatient settings

Detection Method: real-time isothermal amplification
Fluorescence Channel: FAM
TAT: 20 min
Sample extraction: Not required
Controls: Internal & external
LOD: 500 copies/ml
Institutional
04 Point of care diagnostic kit development for diagnosis of Mycobacteria. BIG-BIRAC

A. Collaborations

  • Bahcesehir University (BAU), Istanbul, Türkiye

  • Department of Pathology, National Institute of Sciences and Nutrition, Mexico

  • IIT Mumbai

  • Gujarat University, Ahmedabad, Gujarat

  • Veer Narmad South Gujarat University, Surat, Gujarat

  • Sardar Vallabhbhai Patel National Institute of Technology (SVNIT), Surat, Gujarat

  • Vanita Vishram University, Surat, Gujarat

  • Uka Tarsadiya University, Bardoli, Gujarat


B. Awards and Recognitions

  • NABL accreditation for clinical microbiology testing – 2010

  • RNTCP accreditation for TB diagnosis – 2012

  • H1N1 testing facility approved by State Health Department – 2016

  • NTEP accreditation for TB molecular diagnosis – 2019

  • COVID-19 testing laboratory approved by ICMR – 2020

Details of Seminars, Conferences, Workshops, Training Courses etc., Conducted during the last 3 years
Year Description Uploaded Files / URL
2025 Global TB Clinical and Educational Summit – Oct 14–17, 2025
2025 Introduction of new Molecular POCT at C-CAMP Bangalore
2025 Participation in stakeholder meeting at Veer Narmad South Gujarat University, selected as host institution under NITI Aayog (FITT) national study on research innovation and entrepreneurship in state public universities
2025 Training on Biomedical Waste Management for Lab & Research Staff
2025 Attended 11th Annual Conference of Asian Council of Science Editors
2024 Seminar on Importance of Droplet Digital PCR by BIO-RAD
2024 Expert Talk on Tuberculosis Diagnosis and Research at Gujarat Technology University, Ahmedabad
2024 Training on Internal and External Quality Control for Lab Staff
2024 Invited as Resource Person for World TB Day Awareness Programme at Department of Bioscience, VNSGU, Surat
2023 AMR Masterclass: Isolation and Importance of Clinically Significant Anaerobes in Clinical Microbiology Lab (American Society for Microbiology)
2023 Training on Various Diagnostic Methods at Laboratory for Postgraduate Medical Lab Students