In a first, a single test that will be able to detect tuberculosis and multidrug-resistant tuberculosis was launched Wednesday by Pune-based Mylab Discovery Solutions private limited.
After leading diagnostics innovations for Covid-19, Hasmukh Rawal, MD, Mylab, told mediapersons that they had received Central Drugs Standard Control Organisation CDSCO, TB Expert Committee and ICMR approval for the first indigenous TB Detection kit to detect tuberculosis which simultaneously detects multiple drug resistance to Rifampicin and Isoniazid in a single test.
The kit has been named PathoDetect MTB RIF and INH drug resistance kit. The kit is an RT-PCR-based kit for accurate detection and will be used with Mylab Compact device systems – which will allow automated testing of multiple samples within two hours. “This will be instrumental in supporting the country’s goal to eliminate TB by 2025 from India,” Rawal said.
Presently there are two different tests to be conducted: one to detect TB and the other to check drug resistance – against only one drug (Rifampicin). With this kit, there will be no liquid handling and it is a cartridge-based system. It can process eight samples per run and the machine weighs less than 50 kg. Rawal said that it is ultraportable and reduces the need for expertise of sample handling and processing
The entire project was estimated at a cost Rs 275-300 crore and according to Rawal, the test kit will cost Rs 650. This PathoDetect kit combined with the Mylab Compact device platform will fill the current gaps in tuberculosis testing, a disease which causes more deaths every year than what was seen during the second wave of Covid-19. Annually, 20 lakh new cases of TB are detected and around 4.9 lakh deaths are reported every year due to the disease. Dr Gautam Wankhede, Director, Medical Affairs, Mylab said that data indicates 25% of the global cases of TB were in India and there is a 5-18 per cent death rate in drug resistance.
“The kit has been approved after rigorous and large-scale field trials and recommended by the TB Expert Committee under the aegis of ICMR,” Rahul Patil, CEO at Mylab said.
Multicentre evaluation study and field feasibility testing studies were carried out for the PathoDetect MTB RIF and INH drug resistance kits and Compact device systems. The centres of trials included reputed TB research centres in the country, including National Jalma Institute of Leprosy and other Mycobacterial Diseases(JALMA), Agra, National Institute of Tuberculosis and Respiratory Diseases (NITRD), New Delhi, National Institute for Research in Tuberculosis (NIRT), Chennai, National Institute of Research in Tribal Health (NIRTH), Jabalpur, Regional Medical Research Center (RMRC), Bhubaneswar and Bhopal Memorial Hospital and Research Centre that evaluated the performance of the kit against the currently used diagnostic assays for tuberculosis.
With automation, the complete testing process can be done even in rural areas with the mobile molecular lab. The test kits have been designed to work in ambient temperatures compared to existing PCR options which needed 2-8 degrees cold storage. “Mylab Compact device systems do not require special infrastructure for operations and feasibility studies done on mobile vans in rural areas, which indicates them to be very robust,” Rawal said. The TBConnect App — an Integrated TB Workflow app from diagnostics to treatment — will also directly push results to the central grid and needs no manual upload.
Cy-Tb POC Test for Latent TB
“Mylab and Serum Institute of India have come together to create a unique Cy-Tb solution which is Fast, Accurate, and Cost Effective,” Rawal said. The Drug Controller General of India has granted market authorisation to SII’s Cy-TB kit which can be used as skin test for diagnosis of latent tuberculosis.