Bio Spectrum|June 2020
Accurate diagnosis of coronavirus infection is a very crucial tool to help identify and control the disease. During the ongoing COVID-19 pandemic, there is a lot of buzz regarding the possible errors in diagnoses with both reverse transcription-polymerase chain reaction (RT-PCR) tests and the faster antibody-based tests, all over the world.
RT-PCR testing, which is considered the gold standard for diagnosis of COVID-19, is vital, but it cannot always identify asymptomatic infections or infections in people who may have now recovered. This is where probably antibody tests can help because they look for antibodies even when an individual does not display the symptoms of the infection or has already recovered. But a low accuracy from these tests could diminish their usefulness as a catch-all screening tool.
Adding to this challenge, India is facing a bigger burden of not having enough diagnostic kits in hand. Specifically, there is a shortage of reagents, consumables and equipment required to carry out the diagnostic tests for COVID-19. Expressing his concerns, Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi says, “Our main issue is immediate access of positive covid serum samples to in vitro diagnostic (IVD) manufacturers. Without this, no company can produce a reliable rapid test for COVID-19.”
In order to overcome such issues, India is reaching out to South Korea, USA, Germany and China to arrange for more kits in order to increase the current testing capacity for COVID-19. Although this step might help India to some extent in its current containment plan, the real need can only be fulfilled by accelerating indigenous COVID-19 diagnostics manufacturing.
“The coronavirus outbreak has taken the country completely by surprise, exposing the weakness of public health systems in coping with such pandemics. While it is difficult to foresee what the next virus threat would be, the pandemic focused medical equipment, diagnosis kits could give us a future head start in the battle against any such infectious disease. India needs to collaborate with its world-class IT industry to crack the code of pandemic causing diseases. Presently, India is more dependent on imported diagnostics, however, there is an urgent need for the private sector to shift their focus towards creating cost-effective medical devices and kits for the country and the rest of the developing world”, says Chander Shekhar Sibal, Senior Vice President, Fujifilm India, New Delhi.
For ramping up the current testing capabilities, the government has recently procured COBAS 6800 testing machine from Swiss firm Roche, and has gotten it installed at the National Centre for Disease Control (NCDC), New Delhi. COBAS 6800 is a sophisticated machine enabled with robotics that minimizes the chance of contamination as well as the risk of infection to the health care workers since it can be operated remotely with limited human intervention. However, since the machine requires a minimum BSL2+ containment level for testing, it cannot be placed at just any facility.
At present, India has developed a capacity to conduct more than 1,00,000 tests per day but the majority are conducted through imported kits and machines. A recent episode of questionable testing while using Chinese diagnostic kits has reminded the government to put more focus on pushing India’s capacity to manufacture testing kits with ruthless efficiency. As a result, the licences of the Chinese companies Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics have been cancelled by the Central Drugs Standard Control Organisation (CDSCO), which were earlier approved by the Indian Council of Medical Research (ICMR).
Up till May 15, 45 real-time PCR kits have been validated by ICMR, out of which 21 were found to be satisfactory. 10 of these companies are from India. On the other hand, 42 antibody-based rapid tests have been validated, out of which 13 were found to be satisfactory and 10 of these kits are manufactured in India. Thus, a large number of companies are involved in developing the diagnostic kits but the sheer limitation of the raw materials and resources is hindering the bulk production and mass testing.
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