Tuberculosis is the world’s top infectious killer. In 2017, it killed 1.6 million people. The same year, ten million more were infected. India contributes 27% of the global TB burden as per the World Health Organisation (WHO) Global TB Report. In 2017, a number of people afflicted with TB in India was 2.79 million out of the 10.04 million globally. TB deaths in India were at 4.23 lakhs out of the global death toll of 16.74 lakhs. India also contributes about 25% of the global deaths due to multi-drug resistant TB.
However, the country has set an ambitious deadline to eliminate TB by 2025, a whole five years ahead of the UN’s deadline. But are these declarations in line with the preparations on the ground? When it comes to drugs, diagnostics and counseling (yes, counseling is a crucial component of the WHO treatment protocol for TB), India is “woefully short”, according to Medecins Sans Frontieres’ (Doctors Without Borders) 29-country survey ‘Out of Step 2017.’
Timely diagnostics is crucial to the identification and treatment of TB patients. Each undiagnosed patient can transmit the disease to others. Malden Davies, quoting a study by the Global Coalition of TB Activists, found that it took between a month to over two years for patients to get a proper diagnosis.
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The method most commonly used to diagnose TB in India is sputum smear microscopy, where a patient’s phlegm is smeared on a glass slide and examined under a microscope. It is widely used because it is inexpensive and straightforward. It doesn’t require a laboratory so it can be done in community centres. But it is less sensitive. It misses up to half of the cases. Blessina Kumar, CEO of the Global Coalition of TB Activists, calls this test method archaic and inaccurate.
The WHO-mandated GeneXpert or CBNAAT (Cartridge Based Nucleic Acid Amplification Test) universally for TB suspects and patients in 2010. The test is highly sensitive, takes only two hours to produce a result and tells doctors if the patient has a drug-resistant form of the disease. But it is also expensive and costs between Rs 900-1200 per test. However, India has bought only 1135 CBNAAT machines spread across the 644 districts as of August 2018. Most of these machines are concentrated in and around the metropolitan cities and state capitals.
CBNAAT also requires 24×7 electricity and air-conditioning. It is faster, more accurate and WHO mandated, yet we have very few for a country like India. The reason is cost, explains Dr Jitendar Sharma, CEO of Andhra Med Tech Zone, “At 4.5 lakh rupees per unit, 24×7 electricity and air-conditioning and re-agents (like sputum box) and dedicated staff to run the machine, it worked out to Rs 4,000 per test initially. Now, the cost has stabilised at 900-1,200 rupees per test. But that is too high in a public health setting. Low- and middle-income countries have a record of low to no maintenance of equipment and frequent breakdowns. CBNAAT is no different. The result – a further spike in the test cost. Patients are adversely affected with every breakdown.”
Enter TrueNat. TrueNat is an indigenous test developed by MoIBio Diagnostics Private Limited Goa for rapid detection of multi-drug resistant TB. It is automated, uses battery-operated devices to extract DNA and read specific gene patterns from the patients’ sputum sample. Any resistance to the main treatment drug, Rifampicin, is detected by this machine. TrueNat was suggested by the Indian Council of Medical Research in 2015-16 after comprehensive pilot studies. For interested readers, technical specifications can be found here.
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Andhra Pradesh government has recently adopted it for the entire state for TB testing. It has introduced a creative public procurement model. Instead of buying the machines, they have rented them and pay for the re-agents (like sputum collection box). The pricing is outcome-based, which means the payment for price per test will increase only if there is a decline in TB incidences. So the perverse practice of over-pricing tests in the initial years is done away with.
Additionally, AMTZ provided the incubation site for manufacturing TrueNAT. They also protected the innovators so that there is no hostile take-over bid by big multi-nationals. Currently, a test costs Rs 600. Dr Sharma is confident that there will be a further cost reduction.
The machine is innovated and scaled up, does that mean the test is accessible to TB patients and the most at-risk citizens? The jury is still out on that since Andhra government has just rolled out the machine and test.
One way of bringing diagnostics closer to patients is through a link cadre. Enter the mobile Specimen Collection and Transport (SCT) agents. It is a human resource cadre that Karnataka Health Promotion Trust (KHPT) has introduced in the state of Karnataka and Telengana. KHPT is a leading non-profit in the health and equity space with work in Asia and Africa.
Depending on staff at the diagnostics centre and distance of the health centres (where these diagnostics centres are located), it takes about ten days for the test results to actually reach back to the patient. These delay happens even when advanced machines and tests are present, reports Malden Davies.
SCT agents physically collect samples from the designated TB units at the the health centres and carry them to the testing centres with CBNAAT and TrueNat facility. They bring back the results and hand over the same to the patients. They do all this within a day, shares Dr Prakash Kudur, director of KHPT’s TB programme. This means the patient/citizen can access the diagnostics sooner. “The SCT cadre is agnostic to public or private hospital. If there is a sputum sample, the SCT agents will collect. The fast access to diagnostics and test results means, accurate identification of the exact form of TB and treatment initiation. This gives a fighting chance for cure and survival,” explains Dr Kudur.
TrueNAT and the link cadre of SCT are all innovations to bring TB diagnostics closer to the patients and citizens. Accurate and accessible diagnostics is the first step to TB treatment and cure.
Biraj Swain is a Senior Fellow with the Kalam Institute of Health Technology. She works on international development and human rights in South Asia, East Africa and the UN. She can be reached at biraj_swain@hotmail.com.