Vanguard’s lucky. So far, the Indian Council for Medical Research (ICMR)—the apex body in charge of India’s Covid-19 strategy—had a rather conservative approach to testing. But that is simply no longer an option as the spread of the virus continues.
Already, the infection rate is doubling every four days. Densely populated cities like Mumbai are now feared to have entered the dreaded community transmission phase. States like Maharashtra and Kerala have clamped down on all movement to and from “ hotspots”—areas with a wide prevalence of the disease. Within these zones, states need a quick surveillance and segregation mechanism to figure just how quickly the virus is spreading.
A new phase of response demands a new testing regime. One that’s nimbler, quicker, and less expensive than PCR tests. Rapid antibody tests, like those produced by Vanguard, check all those boxes.
Potentially, rapid tests, which are often pin-prick, point-of-care devices, provide the strategic advantage of screening people en masse. “The first thing is to try and confirm positive cases. We are seeing a large number of asymptomatic cases and we don’t know why. The rapid test can be useful here,” says Radhakrishnan Pillai, a director at the Rajiv Gandhi Center for Biotechnology (RGCB). As Pillai explains, the rapid test is a surveillance tool that provides a scientific way to quarantine people instead of blanket lockdowns. RGCB is developing its own kit.
Unlike Vanguard and RGCB, manufacturing kits locally isn’t an option for most manufacturers. There is little to no access to antigens and other chemicals required to do so. “No one in India makes these chemicals. If we started now, it would take us weeks to culture antibodies,” says the founder of a chain of labs. Instead, Indian companies are looking to procure them from abroad.
According to information sourced by The Ken, multi-chain Indian pathology labs like Thyrocare, Core Diagnostics, and Transasia are trying to import rapid test kits to run validation tests on them internally. Most of these tests come from China, and can potentially be self-administered, like pregnancy test kits.
Rapid test kits, though, are hard to come by. “Only those companies that were able to import these kits in from China now have access. And the prices have gone through the roof,” says an entrepreneur familiar with the supply chain issues for rapid kits. The test kits available are priced between Rs 3,000-4,000 ($39-52), close to what PCR kits cost.
An ongoing geopolitical fist fight over rapid kits is only exacerbating things. After Spain complained of the “poor quality” of test kits delivered by a Chinese company, the Chinese government has banned the export of rapid kits without going through a round of domestic approvals. This move has only hindered access to these rapid antibody kits.
ICMR is currently evaluating 26 different rapid antibody kits and has demanded supplies of 1 million kits from each vendor. As of 9 April, none of these suppliers has delivered kits to India because of strict import controls.
Even those labs that were able to import these kits prior to the lockdown have struggled to validate these tests because of a lack of blood samples. Both NIV and ICMR have become regulatory bottlenecks here, says the founder of a chain of labs, who wished not to be identified because he is waiting on NIV’s approval for his kits.
To circumvent this, some companies are trying to avoid the ICMR-NIV bureaucracy altogether. “We are waiting for our US subsidiary to get US-FDA approval for their rapid antibody kit,” says the founder mentioned above.
As the lockdown clock winds down, rapid testing could hold the key to testing millions. But for that, existing bottlenecks around approval need to be addressed, while questions on pricing, quality control, and usage need answering. Companies, meanwhile, are still in early phases of development, let alone delivery.
Regulation vs clarity
Vanguard is an outlier—it received approvals in a flash. Maybe because of its 2-year-old partnership with Mylab, which produced the first “Make-in-India” PCR testing kit approved by ICMR. Tiwari says that the new antibody kits have been tested against Mylab’s PCR kits to ascertain their level of accuracy. Tiwari did not share the exact results, citing “internal parameters”. (We wrote about Mylab’s PCR test here).