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Development, Evaluation & Scale-UP of non-invasive & low cost rapid TB diagnostics

Primary Information

Domain

Healthcare

Project No.

4404

Sanction and Project Initiation

Sanction No: F.No.3-18/2015-T5.T5.-1

Sanction Date: 29/11/2016

Project Initiation date: 18/03/2017

Project Duration: 36

Partner Ministry/Agency/Industry

Ministry of Health and Family Welfare

 

Role of partner: Scaling up of developed tests. Evaluation of developed tests at JALMA (AGRA, ICMR). Clinical validation of developed tests at National sites: RNTCP (SURAT), GTB Hospital, Surat and Interntational Site: Ethopia or Myanmar.

 

Support from partner: The proposed tests are being evaluated in 444 presumptive TB patients at National Jalma Institute of Leprosy and other Mycobacterial Diseases, Agra (ICMR). These tests are being tested for clinical sensitivity and specificity in comparison to AFB smear/microscopy, gold standard and gene xpert. All collaborators are facilitating place for evaluation as well as clinical validation of the tests.

Principal Investigator

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Professor Rohit Srivastava
Department of Biosciences & Bioengineering, Indian Institute of Technology Bombay, Mumbai

Host Institute

Co-PIs

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Dr. Vinay Saini
Department of Biosciences & Bioengineering, Indian Institute of Technology Bombay, Mumbai

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Prof M. Singh
Lionex Diagnostics and Therapeutics, Germany, Tel: 0049 531 2601266 (Web: www.lionex.de)

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Dr. Joan Miquel Balada Llasat
Associate Director, Clinical Microbiology & Assistant Professor, Clinical Pathology, Division 1492 E Broad St, Columbus, OH,43205 Office: 614 257-2785

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Dr. Dhanji P Rajani
in-charge of Microcare Laboratory and Tuberculosis Research Centre (RNTCP), Surat, Gujarat

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Dr. U D Gupta
Director-in-charge & Scientist-F), National Jalma Institute of Leprosy and other Mycobacterial Diseases Phone: 91-0562-2331756,2232222

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Dr. Lalit Anande
CMO at Sewri TB Hospital, Mumbai

 

Scope and Objectives

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 MPT64 from sputum and other body fluids. b. Development of lateral flow urine strip test for detection of LAM antigen in HIV-co-Infected TB patients. c. Development of Pocket device for semi-quantitative detection of LAM 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.

Deliverables

All these tests will be compared in the patient population to assess clinical sensitivity and specificity. Same patient can be tested are being compared to AFB smear/microscopy, gold standard and gene xpert.

Videos

 

Scientific Output

We have been working on evaluation of proposed TB rapid diagnostics. The following tests are being evaluated at National JALMA Institute for Leprosy and Other Mycobacterial Diseases ICMR Agra in Presumptive TB Patients. 1. Diagnosis of TB antibodies in serum OR plasma 2. TB Urine Strip Test Rapid detection of the LAM antigen, lipoarabinomannan, of the outer cell wall antigen of the bacterium. 3. Development of lateral flow assay for the rapid detection of antigen in sputum. 4. Pocket TB Test- Qualitative detection of IgG and IGM antibodies to MTB in serum or plasma within 20 min. This test is used for rapid diagnosis of active TB. Comparative Standards - Smear microscopy, MGIT culture or liquid culture and Gene Xpert. So far, we have completed evaluation in 203 presumptive TB patients for which we had shown results of 100 presumptive TB patients. Since these evaluation are being done under blind and rigorous process, The results of all tests would be disclosed after completing all analysis before the committee. In the mean time, we have started process to get permission from the ethics committee to start evaluation of these tests at the other suggested sites: 1. Sewri TB Hospital, Mumbai, GTB Hospital, Sewree, Mumbai, India, 2. Microcare Laboratory, RNTCP Lab, Surat, India, 3. Lokmanya Tilak Municipal General Hospital, Sion, Mumbai In this report, we are showing results of around 92 subjects (111 to 203 subjects) completed during November to December, 2018. We had already shown data of first 100 subjects in the last report.

Results and outcome till date

We have completed evaluation of rapid TB diagnostic test in sputum, serum and urine taken from 435 presumptive TB patients. Analysis in rest of the presumptive TB patients (targeted 444) supposed to be completed by August, 2019. These tests are being compared with conventional TB tests (sputum culture, microscopy and gene Xpert). In National Jalma Institute of Leprosy and other mycobacterial diseases (ICMR, Agra), we will be starting evaluation of other TB tests in PPD healthy contacts (number 70) to distinguish latent TB with active TB. Parallel, we have taken permission from IEAC to do evaluation of rapid TB tests in other proposed sites viz. GTB Hospital, Sewri Mumbai, Microacare Lab, RNTCP La Surat, and Sion Hospital, Mumbai. These evaluations can be started only after receiving fund from MHFW, & MHRD, New Delhi. Tests results for different rapid TB Diagnsotics have been shown in figures.

 

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Societal benefit and impact anticipated

In the longer term, we need a simple POC test that can be deployed in the community and health posts in INDIA. Using the tests, the field testing will be affordable and sustainable. Overall goal of the proposal is to improve assays (sensitivity & specificity) and patient care. This test will have great impact on public health by decreasing transmission due to early detection leading to early treatment of TB patients.

Next steps

We have been waiting for rest of the tests results from JALMA (AGRA, ICMR). Simultaneously, we will start evaluation of tests at other proposed sites: GTB Hospital, Mumbai RNTCP Lab, Surat Ethopia or Myanmar (International Testing Site). After completing evaluation, we will do scaling up of these tests in India with the help of partner company.

Publications and reports

One Publication in Conference Proceeding- Development and evaluation of rapid, low cost and affordable TB diagnostics. Supplement of the International Journal of Tuberculosis and Lung Disease (IJTLD) (VOLUME 22 NUMBER 11 NOVEMBER 2018 SUPPLEMENT 2) (PAGES S1 S645 ISSN 1027 3719)

Patents

Under Process

Scholars and Project Staff

We are in need of staff as proposed in our project but due recent fund crunch, we could not hire. Please do release fund asap.


Other Information

We are in need of fund as MHFW and MHRD didn't release complete fund for last two financial years and last year, respectively. Kindly do the needful to avoid any delay in study.

 

Financial Information

  • Total sanction: 2.3
  • Amount received: 1.05
  • Amount utilised for Equipment: 0
  • Amount utilised for Manpower: 1.55
  • Amount utilised for Consumables: 2.4
  • Amount utilised for Contingency: 0.01
  • Amount utilised for Travel: 0.1
  • Amount utilised for Other Expenses: 0
  • Amount utilised for Overheads: 0

Equipment and facilities

 

Homogenizer was purchased previously. Different Test Results are being shown in figures.