Tuberculosis or TB is considered to be one of the biggest health crisis in India. What’s often missed is the fact that TB cases suffer from delayed and inaccurate diagnosis. Accurate diagnosis of TB is critical for the treatment and infection control. Timely and correct diagnosis curtails the cycle of TB transmission and helps in commencing TB treatment at the earliest.
However, an inaccurate diagnosis in the public or private health centre, not only causes suffering to the patient but also feeds into India’s TB epidemic.
Diagnosis of TB in India is often delayed – sometimes as long as two months. Patients often end up visiting three different healthcare providers before a diagnosis is made. In addition, lack of universal testing for drug-resistance means that patient with drug-resistant forms of TB are not diagnosed correctly and often mismanaged. This results in increased drug-resistant TB transmission that can cause extensive suffering, loss of life and inadvertent poverty.
India’s healthcare system is divided into public and the private healthcare sectors. Both the sectors use different diagnostics for TB detection.
Sputum smear microscopy – the most widely used method of TB diagnosis – is used in the public sector and misses more than half of all cases. Its inaccuracy leads to misdiagnosis and results in faster TB transmission as the patients are not put on appropriate treatment.
In the private sector, where more than half of TB patients are managed, the quality of care is highly variable, and there is rampant use of inappropriate diagnostics. There are well-documented examples of over-treatment and use of irrational drug regimens.
In May 2012, the Government of India (GoI) banned the manufacture, sale, distribution and import of sero-diagnostic (blood-based antibody tests) kits for TB diagnosis. The ban followed a negative policy recommendation issued by the World Health Organisation in 2011.
International Standards for TB Care (ISTC), widely endorsed by several agencies, including the National Programme and Indian Medical Association (IMA), discourage the use of TB blood tests.
However, the private sector has started misusing another blood test – Interferon Gamma Release Assay (IGRA) – to diagnose active TB. These are actually intended for detecting latent TB. The use of IGRAs to detect active TB results in unacceptably high rates of false-positive results, because IGRAs cannot separate latent TB infections from active TB disease, and a large proportion of the Indian population is infected latently.
Although WHO endorsed rapid diagnostic test, GeneXpert is now included in the public program but it is yet to reach scale. Currently, the test is mainly used for drug-resistance testing in select, high-risk groups. Without scaling up such tests, it will be impossible for India to address its growing burden of drug resistant TB.
Impact of ineffective diagnostics
The overuse of methods like sputum smear microscopy and the underuse of others- such as rapid molecular tests- pose problems. This situation leads to a delayed diagnosis of TB and drug-resistant TB, causes the patient to suffer and perpetuates the cycle of TB transmission. It also leads to rising medical costs and causes debt and poverty among the families of the TB affected. In effect, we are creating a crisis that can be easily avoided.
What can be done?
There is an urgent need to create and implement a robust national policy on TB comprising three main components. First, a stringent mechanism is urgently needed to regulate the use of sub-optimal TB diagnostic technologies. Second, India needs to rapidly uptake and roll out of WHO endorsed new TB diagnostic technologies. We also need to create parameters for strict evaluation of new incoming technologies so that no ineffective technologies are allowed to exploit the vast need in the private sector- the world’s largest market for TB diagnostics.
Finally, we need increased investment in home grown solutions to aid accurate and early TB diagnosis. Our investment in Research and Development continues to be limited. India needs to spur its scientific prowess to solve its growing health concerns. This will ensure we create diagnostics that are affordable and more suitable to our conditions.
We have to recognise that India cannot defeat its TB epidemic until we provide the millions of affected people quick and accurate diagnosis, including access to drug resistance tests. The regulation of diagnostics and the introduction of new technologies is an essential step in India’s fight against TB. Until we do so, TB will continue to make Indians suffer and die, placing an enormous social and economic burden on India. It is essential that the people of India, especially its most disadvantaged, be protected from TB.
– Sarman Singh is a TB expert and professor at All India Institute of Medical Sciences, New Delhi. This blog is contributed by Survivors Against TB – a community-based movement led by a group of TB survivors who are working to strengthen India’s fight against TB.
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