Govt Interventions Like R&D Grants Needed To Boost Manufacturing Antigen Test Kits: Expert

According to Manav Teli, executive director of Lord's Mark Industries, government interventions such as streamlining regulatory processes, offering research and development grants, and facilitating partnerships between manufacturers and healthcare institutions are some of the ways to boost antigen test kit manufacturing.

Lord's recently partnered with Hindustan Antibiotics Limited to distribute low-cost rapid antigen kits throughout the country. Malaria, cardiovascular disease, hepatitis C virus (HCV), HIV, syphilis, hepatitis B surface antigen (HBsAg), dengue, typhoid, Covid, chikungunya, ovulation, and pregnancy are all detected by the company's rapid test kits. The fim recently launched its 20,000 square feet in-vitro diagnostics (IVD) manufacturing facility at Vasai near Mumbai.

The facility manufactures IVD and point-of-care diagnostic solutions such as analysers, reagents for clinical biochemistry, haematology, serology, immunology, rapid testing kits (ICMR-approved antigen kits), and lab consumables. “India had imported RT-PCR kits from Korea in 2020 worth Rs. 4,280 per test kit, India had the capability to produce 3,000 RT-PCR kits per day just after 15 days on April 7, 2020. In another 4 months, the production scaled up to 12 lakh per day and today it stands at 15 lakh per day which is above the national consumption pattern today. There is a need for indigenous manufacturing of antigen test kits in India.

As of today, antigen and RT-PCR tests are concerned, India has achieved the level of self-sufficiency in domestic production and exports and even at the technology front also,” Teli informed. Teli went on to say that while there are many antigen tests on the market today, reliable test results are dependent on three important factors: assay architecture (how the test is designed), process controls (how can the instrument ensure that each and every test follows the reaction scheme correctly), and measuring technology (lateral flow, Elisa, and enhanced chemiluminescence, among others). "Serological tests detect human antibodies, which are far more stable than viral RNA." Serology specimens are thus more resistant to operational challenges during collection, transport, storage, and testing.