The process of the antibody test

For other diagnostic companies in the running, however, ICMR’s approvals process has been slow, complex and confusing. “We’ve submitted our documents to them thrice. We still haven’t heard back. Time is of the essence, and both supplies and price points need to be managed,” says Tarshant Jain, co-founder of OZO life, a UK-based diagnostic firm.

What has especially stumped Jain is that while OZO’s kit made it to the first list of approved tests published by ICMR on 28 March, it was delisted in a subsequent list put out on 4 April. Without explanation, Jain claims.

OZO isn’t alone in its frustration. NIV’s stringent and opaque testing criteria have scared off diagnostic chains that have developed in-house antibody kits. “With NIV, I get one shot at approval. They don’t even share data on the accuracy level of the test. It’s just pass or fail,” says the diagnostic lab chain founder mentioned earlier.

Without feedback on the accuracy levels or access to Covid-19 patient blood samples, says the founder, it’s impossible to manufacture tests at scale. “We have enough capacity to manufacture up to 100,000 tests. But we’re getting stuck in bureaucracy,” the founder continues, adding that more NIV testing labs should be pressed into action to fast-track the process.

The approval

Instead of waiting for NIV’s approval, the lab chain is now focused on getting US FDA approvals for a kit being worked on by its US-based subsidiary. “If they have [EU’s] CE-IVD and US-FDA approval, NIV is not going to re-validate these tests. They can directly get permission from the Drugs Controller General of India [DCGI] to import and use. ICMR just lists these tests,” explains Samiran Panda, director of the National Aids Research Institute, one of four NIV labs with permission to test Covid patient samples.

Even though they started later, says the founder, the US labs got quick access to blood samples and were able to generate the antigen required to make these antibody kits.

The foreign certification route, however, leaves a wide and rather disingenuous accountability gap. What if a CE-IVD approved rapid test gives a high number of false positives or negatives? Spain, for example, procured kits from a CE-IVD certified Chinese company, Shenzhen Bioeasy. According to reports, the accuracy of these kits was below 30%.

Such levels of inaccuracy could defeat the very purpose of these kits. It could overwhelm hospitals with misdiagnosed patients or worse, allow infected persons to spread the virus undetected. While Shenzen Bioeasy has publicly defended the quality of its tests, the incident has made diagnostics chains and distributors wary of faulty products.

“Ultimately, it’s the lab that’s going to be responsible for any mess. We just can’t take that chance,” says the owner of a Gurugram-based diagnostic chain. The company is currently in talks with four foreign suppliers to source rapid testing kits for India.

To be on the safe side, labs that are importing kits, are conducting their own internal trials before putting them on the market.

“We have ordered 5,000 test kits each from four manufacturers. This is an unprecedented disease. There are no yardsticks. We just have to try everything out,” says A Velumani, founder of the Thyrocare chain of labs. Chinese export restrictions have meant that these kits will only arrive by 15 April, with Velumani saying Thyrocare requires another 15 days to validate these kits.

Home comforts

Indian distributors are right to worry about shoddy tests. But without relying on imports—of either the kits or the raw material that goes inside them—India is severely restricted in the number of rapid tests it can roll out.

A select few, like Vanguard’s Tiwari and RGCB’s Pillai, have a head start, but that won’t last very long. Pillai, the scientist spearheading RGCB’s efforts, says it was sheer luck RGCB had cultivated the antigenic material (required to build the test) in January. “We have enough resources to produce 75,0000 to 100,000 tests a day,” says Pillai. Pillai, though, admits that a lack of sufficient antibodies could hamper production going forward.

In addition to the limited quantity of the raw material, Pillai is also waiting for a shipment of colloidal gold from Mumbai. This has been delayed due to the lockdown. Colloidal gold is a detection agent of the antibody test.