Diagnostics

Need For Improved Diagnostic Tools

For a low resource setting like India, there is a dire need to have affordable, portable and rapid tests for TB diagnosis. Sputum smear microscopy, a conventional method for detecting Mycobacterium tuberculosis (M.tb), is more than 100 years old. Culturing M.tb takes about 3-6 weeks to yield results. For drug susceptibility tests, this may take even longer. This leads to a prolonged delay in diagnosis, ultimately resulting in delayed treatment which could exacerbate the course of the disease. The global introduction of a diagnostic Nucleic Acid Amplification Test (NAAT),has brought about a revolution in TB diagnosis as it not only rapidly detects TB but also resistance to rifampicin.

The goal of this domain would be to develop and ensure access to new and improved diagnostics to detect active disease at the point of care, diagnose latent TB infection, predict disease progression, and rapidly screen drug resistant TB and paediatric TB.

Role of ITRC

ITRC will accelerate the development of an indigenous point of care accurate diagnostics suitable to Indian conditions. This could help improve access to rapid and early diagnosis of TB and save millions of dollars in foreign exchange as all modern diagnostic tests for TB are currently imported. ITRC could also help validate and approve the entry of TB diagnostics controlling the use of sub-optimal diagnostics, thus ensuring that patients receive effective and accurate diagnostic technologies.

Objectives

ITRC will accelerate the development of an Indian point of care accurate diagnostics suitable to Indian conditions. This could help improve access to rapid and early diagnosis of TB and save millions of dollars in foreign exchange as all modern diagnostic tests for TB are currently imported. ITRC could also help validate and approve the entry of TB diagnostics controlling the use of sub-optimal diagnostics, thus ensuring that patients receive effective and accurate diagnostic technologies.

• To develop and validate new cost effective preferably POC diagnostic tests/biomarkers including a non-sputum based point of care tests
• To do field feasibility studies to evaluate the validity, clinical impact, and cost-effectiveness of new molecular tests aimed at the microscopy center level in India
• To validate molecular testing at the DMC level to inform national policies to decentralize and replace smears for rapid case detection
• To identify and develop lower cost CXR technologies with computer assisted diagnosis (CAD) capability and validate the new strategies for X-ray technology, fixed or mobile in partnership with the industry.
• To Improve the diagnostics R&D ecosystem in the country by creating:
  • sample and strain banks for product developers
  • target product profiles and market analyses
  • mentorship opportunities in TB space
  • a National Essential Diagnostics List and ensure the inclusion of TB in this list
  • locally manufactured, quality assured EQA panels for Quality assurance and accreditation of labs for TB
  • models to make validated, RNTCP endorsed TB tests more affordable and accessible to the private sector in India

Deliverables

• A new rapid point of care diagnostic test/kit for TB /MDR-TB –highly sensitive cost-effective,
• A rapid point of care diagnostic test replacing sputum microscopy that will improve TB detection, and enable screening of high-risk communities
• A validated better triage test for early diagnosis of TB.
• A cost effective Next generation sequencing platforms that would replace current imported, expensive MDR TB detection tests
• A centralized facility to collect, processes, stores, and distributes bio specimens to support future scientific investigations.

Progress So Far

A detailed report of the current status of national and international leads in diagnostics has been developed. Through a series of intensive discussions with experts and other stakeholders, an indigenous Nucleic Acid Amplification Test (NAAT) has been identified for validation and testing. This test is highly sensitive and specific for detecting TB and provides results within an hour compared to the conventional methods that can take days to report results. The test can be used at DMC level and can replace smear in future. In terms of cost effectiveness, the indigenous test can bring about a revolution in transforming the diagnostics landscape for not only India, but also for low and middle income countries.

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ITRC: India TB Research Consortium