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The COVID-19 crisis deepens

In spite of almost having reached the 1 million tests per day figure, it is a herculean task to keep track of the disease progression.

The worldwide COVID-19 crisis has spawned hundreds of diagnostic testing kits and regular announcements. Conducting less than 100 COVID-19 tests each day at the time of initial outbreak in January, the Indian government was facing intense criticism for lack of testing. Then, India had only one laboratory testing COVID-19, at the Indian Council of Medical Research’s National Institute of Virology, Pune. Now the government conducts 900,000 tests per day in 1564 labs in the country; 998 labs in the government sector and 566 private labs, some of them being drive-through.

RT-PCR and rapid antigen. With a manufacturing capacity of 1 billion RT-PCR kits, on an average, daily testing of 600,000 samples is being done. The balance are the more affordable and quicker rapid antigen tests. Many Indian states, which decide their own testing protocols, have been increasingly turning to this method. Maharashtra, Delhi, and Telangana are major users of antigen tests.

PCR tests are diagnostic. They indicate if the person is infected with COVID-19. Antibody kits are more an epidemiological tool. They indicate if the blood has antibodies that are triggered to fight the virus. But for a bunch of reasons—cost, easy use, accessibility—antibody kits were considered the first line of defense in India’s COVID-19 strategy, at least in the first few months of the pandemic. While molecular testing detects whether someone has the virus, antibody tests determine if someone is infected.

Testing developments
Following the country’s foray into PPE and ventilators manufacturing, in March-April, Delhi-based Medsource Ozone Biomedicals, Chennai-based Helini Biomolecules, Malaysia-based ADT Biotech, Pune-based MyLab, Bhopal-based 3B BlackBio Biotech,  South Korea’s Seegene and SD Biosensor, and China’s BGI received approvals for RT-PCR test kits.

On the rapid test front, the ICMR gave approvals to Ambala-based Alpine Biomedicals, Pune-based Immunoscience and Delhi-based Nulife Care. Earlier, Delhi-based Vanguard Diagnostics, Surat-based Voxtur Bio, Chennai-based CPC Diagnostics and government-run HLL Lifecare had received approvals alongside China’s Zhuhai Livzon Diagnostics.

India is also developing key ingredients used in the COVID-19 test kits since early July. The two critical items—fluorescence probes and polymerase chain reaction mix—are developed by VNIR Biotechnologies Pvt. Ltd, a spinoff by Jawaharlal Nehru Centre for Advanced Scientific Research, an autonomous institute under the department of science and technology (DST). A typical PCR-based test kit includes three critical components—oligos, enzymes, and molecular probes. Oligos and enzymes are partly available in India, while the molecular probes are completely imported.

The Indian Institute of Technology (IIT) Delhi has launched a low-cost and probe-free, test kit, which use an alternative testing method. With this IIT Delhi has become the first academic institute to develop a COVID-19 testing method. The institute has kept a price rider of Rs 500 per kit.

The government has approved a rapid antigen test, Pathocatch on July 23. The product is developed and manufactured by Pune-based Mylab Discovery Solutions, in partnership with Gujarat-based LabCare Diagnostics.

ICMR has also validated Indo-South Korean, SD Biosensor (manufacturing its kits in Gurugram, Haryana), among 14 companies of rapid antigen test kits that have approached the regulatory body for approval so far. Seven of the other companies are Indian while others are from South Korea, Taiwan, Singapore, and Belgium.

While the kits of Camtech Diagnostics (Singapore), Agappe Diagnostics (India), Rapigen Inc of South Korea, POCT Service Pvt Ltd (India), and HLL Lifecare (India) are in transit; the response is awaited for Coris Bioconcept (Belgium), J Mitra & Co. Ltd (India), Medsource Ozone Biomedicals Pvt. Ltd (India), Panion & BF Biotech, and Formosa Biomedical Technology Corp (both from Taiwan).

Thermo Fisher Scientific has a current capacity of supplying 150,000 RT-PCR test kits per day. At present, Thermo Fisher makes the kits at its central facility in the US and these are imported into India.

Roche Diagnostics, received the government’s approval for the IgG-based antibody test kits launched the kit in India in June.

Abbott’s SARS-CoV-2 IgG test demonstrates specificity and sensitivity to detect IgG antibodies of greater than 99 percent, fourteen days or more after symptoms started.

The month of July witnessed the inauguration of the country’s first mobile RT-PCR testing lab. The Indian Institute of Science (IISc) has developed this Mobile Infection Testing and Reporting (MITR) lab, which has now been handed over to the Rajiv Gandhi University of Health Science. This lab has the capacity of conducting 9000 tests.

Mumbai-based Vishat Diagnostics has received approval for the antigen kit manufactured by Coris BioConcept. The company plans to launch the testing kit, COVID-19 Ag Respi-Strip, at a price of Rs 425.

India and Israel have collaborated to develop a new kind of coronavirus rapid testing kit that is expected to be able to deliver results in 30 seconds. Israel’s ministries of foreign affairs, defense and health have been working with India’s chief scientist, K Vijay Raghavan and Defence Research and Development Organization (DRDO) to develop this kit.

South Korea’s LabGenomics has bagged a deal to supply advanced RT-PCR test kits to Siemens Healthineers in India. The company has signed a 5.8 billion won (USD 4.8 million) for LabGun COVID-19 ExoFast, that can detect the virus infection in 35 minutes and India is the first country to have access to it.

On August 26, ICMR validated Delhi-based Oscar Medicare’s indigenous point-of-care (POC) rapid test kits to detect coronavirus antibodies, which can deliver results in 20 minutes. The company is planning to launch 200,000 test kits in September. The rapid testing kit will be priced around Rs 200.

The import-export dilemma resolved
As the number of daily COVID tests are rising globally, a superfluity of RT-PCR testing kits had both domestic manufacturers and multinational importers criticize the government policies. The government had imposed zero import duty and an export ban on the surplus testing kit stock.

With most domestic manufacturers importing components to assemble finished products, there were initially certain quality issues evident from the low acceptance of Indian test kits. Facing the glut, a number of domestic companies, under the umbrella of the Association of Indian Medical Device Industry (AIMED) urged the government to lift the export ban.

In the first week of August, the Indian government allowed restricted shipment of these kits. The Indian manufacturers are now set to export their products to the markets of Latin America, East Asia, and Eastern Europe. The Directorate General of Foreign Trade (DGFT) has fixed export quotas for 23.8 million viral transport media kits (VTM kits) and 10 million RT-PCR kits including swabs for August.

A lose-lose situation
Almost six months into the pandemic, the IDSP (The Integrated Disease Surveillance Programme) survey shows that given India’s large, young population, 80 percent of those recorded to have had the disease show no symptoms. And 30 percent of the remaining 20 percent get a fever.

COVID-19 surveillance is tricky. Someone with no symptoms to start with might end up developing symptoms later. It seems a no-win situation at the moment!

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