TB diagnosis in India – Challenges and opportunities

Dr Sanjay Sarin

India ranks #1 in the world and constitutes 1/5th of the global TB burden. Every year, in India close to two million people develop the disease with nearly 40 per cent of them being infectious. Almost 1,000 people die of this curable disease in India every day. TB primarily affects people in their most productive years of life with almost 70 per cent of the patients being in the 15-54 years age group. The disease continues to be a key deterrent to social and economic development with a staggering annual economic burden in excess of $ 3 billion in direct and indirect costs1. It is estimated that about 170 million workdays are lost annually in the country due to this disease2.

India along with China contributes nearly 50 per cent to the global burden of Multiple Drug Resistant TB (MDR-TB). The rate of MDR-TB infections in India in new and retreatment cases is 2.1 per cent and 15 per cent respectively. Out of nearly 65000 notified MDR-TB infections in 2011, only 3,384 patients have been put on treatment3. According to the WHO’s MDR-TB and XDR-TB report (2011), though significant efforts are being made, more needs to be done to achieve the goal of universal access by 2015.

In India also, the government is taking significant steps to curb the menace of TB. In fact the DOTS programme in India has been a major success and is cited as a best case example across the world. However, the scourge of drug resistant TB and HIV-TB co-infection is threatening to reverse these gains. It is therefore imperative to have a comprehensive strategy inclusive of both diagnostic and therapeutic interventions to fight this epidemic. Improvements in existing approaches and implementation of new diagnostic tools for rapid and improved diagnosis of TB, MDR/XDR-TB and HIV-TB co-infection are needed. The strategy should include all the key stakeholders such as national TB programmes (NTPs), technical partners, civil society representatives, product developers, donors as well as the corporate sector.

The last few years have seen the introduction of many new WHO diagnostic technologies starting with the liquid culture in 2007, followed by the line probe assay, LED microscope and more recently cartridge-based nucleic acid amplification technology such as the GeneXpert. Efforts are also being made to ensure the introduction of these technologies into the country TB diagnostic algorithms. It is important to note that all these technologies are complementary and are not necessarily substitutes for each other. In fact, WHO has developed new diagnostic algorithms which have appropriately included the above mentioned newly approved diagnostic technologies from a screening and treatment monitoring perspective.

In addition to this, WHO recently issued a negative guidance on serology-based TB tests and subsequent to that Government of India has banned the sale and manufacturing of these tests in India4.

According to the WHO TB serodiagnostics tests policy statement5, “It is strongly recommended that these commercial tests not be used for the diagnosis of pulmonary and extra-pulmonary TB as currently available commercial serodiagnostic tests (also referred to as serological tests) provide inconsistent and imprecise findings. There is no evidence that existing commercial serological assays improve patient outcomes, and high proportions of false-positive and false-negative results may have an adverse impact on the health of patients.”

Serology-based TB tests have been a big bane in India and a major reason behind delayed diagnosis and subsequent unfavourable treatment outcomes of TB patients. The banning of these tests is a big step in the positive direction and should certainly be helpful in the introduction of WHO approved diagnostic technologies in the private sector. In view of the fact that more than 70 per cent of the Indian population seeks treatment in the private sector it is critical to engage the private sector to not only utilise the available capacity but to also build meaningful linkages with the national TB program. In addition to engaging the laboratories in the private sector, it is also important to align the physician community on the benefits of WHO approved technologies, as prescribing the approved TB diagnostic tests will be key to improving the lot of TB suspects in the country.

BD through its Global Health Initiative is helping create long-term health solutions to fortify overburdened and under-resourced healthcare systems in three primary ways:

1. Increasing access to critical and state-of-the-art disease monitoring technologies
2. Building capacity and improving quality of care in resource constrained settings and
3. By investing in new and market appropriate technologies for the developing world

BD has been actively engaged in building public-private collaborations, as well as partnerships with the industry to advance the cause of improved TB diagnosis in India. BD is working with key stakeholders to build a platform for wider private sector participation in TB disease management. BD is instituting a mechanism of sustainable pricing coupled with technical assistance for capacity building in TB diagnosis through good laboratory practices programmes, developing centres of excellence and participating in industry forums to strengthen the voice for improved TB diagnosis and better patient outcomes.

BD is working with both Revised National TB Control Programme and FIND (Foundation of Innovative New Diagnostics) to develop capacity for TB culture and drug susceptibility testing in 33 laboratories across India. BD also worked with FIND and Alliance Biosafety to establish a centre of excellence in biosafety in Bangalore to address biosafety issues associated with laboratory diagnosis of drug-resistant TB.

BD believes that improvements in laboratory technologies are critical towards strengthening the continuum of TB care including diagnosis and monitoring in the country eventually leading to overall strengthening of healthcare systems. These improvements will not only address current crises, but can also support future healthcare needs in emerging economies such as India.

References:

1. RNTCP annual status report, 2011.
2. Tuberculosis situation in India – www.tbassnindia.org (accessed feb 2013),
3. WHO Global Tuberculosis Report, 2012.
4. TB: Centre bans ‘inaccurate’ serology tests, The Indian Express, Pune, June 20, 2012
5. WHO, Tuberculosis Serodiagnostics Tests, Policy Statement, 2011