India, with its high tuberculosis (TB) and multi-drug resistant tuberculosis (MDR-TB) burden, has long been looking for an affordable, high-sensitivity test to be used in the most peripheral health facilities with least technical complexity, minimal infrastructure and training. To address the issue, the state health department has now come up with a cost-effective measure of using 'Make in India' initiative to identify TB cases.
The detection of MDR-TB in the state a couple of months back took a backseat following an acute shortage of testing kits because of less number of cartridges. The health department has now started using a commercial nucleic acid amplification tests (NAAT) for TB detection. Rifampicin-resistance line probe assay (LPA) and Xpert MTB/RIF (Xpert) have also been introduced and being scaled up within the Revised National Tuberculosis Control Programme (RNTCP). With the success of these technologies, promising indigenous LPAs have been developed for rapid TB diagnostics.
TrueNat MTB is an indigenous molecular test developed by MoIBio Diagnostics Pvt Ltd Goa for rapid detection of MTB using real-time micro PCR (polymerase chain reaction). Automated, battery-operated devices are used for extraction of DNA (Trueprep Auto device) amplification (TrueNat MTB chip) and reading the presence of specific genomic sequences (TruelabUnoDx real-time PCR analyser) using patients’ sputum samples. Any resistance to rifampicin (RR) is detected by doing a second RTPCR (Reverse transcription polymerase chain reaction) as a reflex test using the same DNA that identifies selected rifampicin- resistance associated mutations.
“Following earlier evaluations in India, the current multi-centric field study is being planned to demonstrate the performance of TrueNat MTB Rif. There are five sites in Maharashtra where 10 TrueNat machines have been installed in each district at two microscopic centres at Mumbai, Thane, Kolhapur corporation, Aurangabad and Hingoli,” said Dr Sanjeev Kamble, joint director of health (tuberculosis and leprosy).
“We have also evaluated the reports and working of the TrueNat machines in comparison to the present CB-NAAT (more popular as GeneXpert) machines and the reports of the diagnosis are found to be same. The TrueNat machines costs less (Rs 4.5 lakh) to the department as it is Indian. The cost for the diagnosis of a single person will be around Rs 300-400 whereas the cost of cartridges of CB-NAAT machines is between Rs 2,500 and Rs 3,000. One cartridge is used to test six people,” Dr Kamble added.
Tata Institute of Social Sciences (TISS), Mumbai, has also come forward to provide special counsellors to counsel for the TB programme. “TISS has given us 57 experts for the counselling of TB patients for the state programme. The counsellors will be assigned to work across the state and will be there to counsel the patients at district level. Counselling is an important programme as most of the patients stop taking medicines before completing the course of medicines which cause recurrence,” Dr Kamble further added.
Dr Sandeep Bharaswadkar, consultant state TB programme, World Health Organisation, said, “Currently, there are 72 CB-NAAT (more popular as GeneXpert) in the state and more than 40 CB-NAAT machines will be added to the programme. The evaluation and results of both the machines are same and we will soon decide about the new TrueNat machine procurement. These machines will be installed in all rural health hospitals across the state.”
Source: Pune Mirror