Jun 30 2017 : The Times of India (Chennai)
New tool gives TB patients a breather, cuts test cost 50%
Umesh Isalkar & Ekatha Ann John
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PuneChennai:
TNN
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Scientists from the Indian Council for Medical Research (ICMR) are working on an indigenous DNA-based sputum test for tuberculosis (TB) and drug-resistant TB, which will bring down the cost of the TB test by at least half.The diagnostic tool, TruNat, which has shown promise in preliminary studies, is now being tested for feasibility in 50 districts in 10 states, including Maharashtra and Tamil Nadu.
“If the new kit passes the test, the cost of diagnosis would come down by as much as 50%,“ ICMR director-general Sou mya Swaminathan told TOI.
Currently , TBMDR-TB detection using the US-made GeneXpert system costs the government `1,600 per test.
The `Make in India' diagnostic tool for TB detection -TruNat -costs only `450 and is on par with the imported technology, experts said.
“Once the results of the preliminary studies are out by August, we will scale it up following the go-ahead from the Union health ministry ,“ Swaminathan said. “The aim is to weave this indigenous molecular test in the primary healthcare set-up as it gives the same kind of TB diagnosis as GeneXpert and shows resistance to rifampicin -a key first-ling drug -within the same time span.“
While the indigenous device will not replace the imported system, it could be an effective alternative in the rural areas as it is portable and battery-operated.
N S Gomathi from the Chennai-based National Institute for Research in Tuberculosis (NIRT) said a recent multicentric validation study in India had shown promising results. “However, the test ne eds to be studied further to demonstrate its simplicity and operational feasibility in field settings,“ she said. Gomathi is coordinating the feasibility study .
Experts who TOI spoke to said that though GeneXpert is portable, there are practical difficulties. It has an attached UPS and requires an air-conditioned set-up, which may not always be available in rural settings. “ As part of the ongoing study , we are factoring in various parameters like power fluctuations and whether people can interpret the reading on the device, which is the size of a landline phone,“ Gomathi said. When contacted, Raghuram Rao, deputy ad ditional director general (TB), Union ministry of health, said the only edge GeneXpert has over TruNat is that it can churn out results of four sputum samples at a time, while the latter can test only one sample in one go. “TruNat is, however, easier to use, portable and has higher sensitivity than smear microscopy ,“ he said. Maharashtra state tuberculosis officer Sanjeev Kamble said the feasibility study of TruNat is currently underway in five districts of the state, including Mumbai, Aurangabad, Hingoli, Kolhapur and Thane.
While the conventional smear test done under RNTCP may not always be accurate, the DNA-based tests are done for those who test negative in preliminary screening, despite showing TB symptoms.They are also done for children and others with co-morbid conditions, such as HIV .
India has 22 lakh TB cases, the highest in the world, of which up to 3% are estimated to be multi-drug resistant. The number of “missed“ TB cases in India is about 10 lakh. Early diagnosis and treatment of TB is important to prevent the transmission of disease and to improve TB treatment outcomes, expert said.
“If the new kit passes the test, the cost of diagnosis would come down by as much as 50%,“ ICMR director-general Sou mya Swaminathan told TOI.
Currently , TBMDR-TB detection using the US-made GeneXpert system costs the government `1,600 per test.
The `Make in India' diagnostic tool for TB detection -TruNat -costs only `450 and is on par with the imported technology, experts said.
“Once the results of the preliminary studies are out by August, we will scale it up following the go-ahead from the Union health ministry ,“ Swaminathan said. “The aim is to weave this indigenous molecular test in the primary healthcare set-up as it gives the same kind of TB diagnosis as GeneXpert and shows resistance to rifampicin -a key first-ling drug -within the same time span.“
While the indigenous device will not replace the imported system, it could be an effective alternative in the rural areas as it is portable and battery-operated.
N S Gomathi from the Chennai-based National Institute for Research in Tuberculosis (NIRT) said a recent multicentric validation study in India had shown promising results. “However, the test ne eds to be studied further to demonstrate its simplicity and operational feasibility in field settings,“ she said. Gomathi is coordinating the feasibility study .
Experts who TOI spoke to said that though GeneXpert is portable, there are practical difficulties. It has an attached UPS and requires an air-conditioned set-up, which may not always be available in rural settings. “ As part of the ongoing study , we are factoring in various parameters like power fluctuations and whether people can interpret the reading on the device, which is the size of a landline phone,“ Gomathi said. When contacted, Raghuram Rao, deputy ad ditional director general (TB), Union ministry of health, said the only edge GeneXpert has over TruNat is that it can churn out results of four sputum samples at a time, while the latter can test only one sample in one go. “TruNat is, however, easier to use, portable and has higher sensitivity than smear microscopy ,“ he said. Maharashtra state tuberculosis officer Sanjeev Kamble said the feasibility study of TruNat is currently underway in five districts of the state, including Mumbai, Aurangabad, Hingoli, Kolhapur and Thane.
While the conventional smear test done under RNTCP may not always be accurate, the DNA-based tests are done for those who test negative in preliminary screening, despite showing TB symptoms.They are also done for children and others with co-morbid conditions, such as HIV .
India has 22 lakh TB cases, the highest in the world, of which up to 3% are estimated to be multi-drug resistant. The number of “missed“ TB cases in India is about 10 lakh. Early diagnosis and treatment of TB is important to prevent the transmission of disease and to improve TB treatment outcomes, expert said.
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