India gears up for rapid virus testing as rising hotspots ring alarm bells

Bengaluru-based Bione to launch test kits next week

Bengaluru-based biotech start-up Bione is set to put on the market by next week an antibody-based rapid test kit for Covid-19 that will give results at home in 10-15 minutes. Some other companies too are in the fray.

As several hot spots emerge in the country, the Indian Council of Medical Research (ICMR), the country’s apex health research body, on Thursday issued an interim advisory to use rapid test kits in the hot spots to screen the population.

Firms like Bione can play the role of a game changer in the coronavirus-testing landscape of the country.

The ICMR has so far approved about 12 rapid antibody test kits for Covid-19 diagnosis. Of these, around seven are from China, and the rest from the US and Singapore.  These kits hitting the Indian market is now a matter of time.

Sources said India had procured around 500,000 antibody-based test kits recently.

The test used now, called PCR (or polymerace chain reaction), uses a nasal or throat swab sample and identifies the virus. These tests take at least five hours to give results.

Pune-based MyLab developed Patho Detect in six weeks and it gives results in two and a half hours or so.

The rapid test, on the other hand, uses a blood sample and gives results based on detecting the presence of certain antibodies that react to the coronavirus protein.

Bione’s kit is an immunoglobin-based tool that can say if the affected person is in early or late stages of infection. A blood drop is collected using a lancet, and then the cartridge provided reads the results from the blood sample in five to 10 minutes. The kit will be priced at about Rs 2,000, depending on the import cost.

The Centre on Tuesday told the Supreme Court that there was a possibility that three of every 10 migrant workers who were going back to their villages might carry the virus.

Rapid blood-test-based kits could be used in public health centres in the villages, said Surendra K Chikara, founder and chief executive officer of Bione and a genomicist himself. Bione is readying its manufacturing infrastructure in Bengaluru. That, Chikara said, will take about three months.

In the meanwhile, it will import kits from partners globally who have the approvals of Europe's CE (Conformitè Europëenne) and the Food and Drug Administration (USFDA). Chikara claimed that for starters they can supply 100,000 kits per month (by importing). This can be scaled up once their own manufacturing facility is ready to go.

Once the screening is done, those found postive can be then recommended for the PCR test for confirmation. Used in hotspots like Nizammudin (Delhi), Worli and Dharavi in Mumbai, or Bhilwara in Rajasthan etc, the anti-body tests could help to detect people with minimal or no symptoms at lower costs and faster.

The imported kit based PCR test costs Rs 4,500. Indigenous kits from Mylabs etc would cost much less. A Mylabs kit can test 100 samples at one go (at a lab), bringing the cost down to around Rs 1,500 per test. However, availability of kits for PCR testing is a critical issue.

A senior government official said,"States are now trying to procure PCR test kits directly from private companies like Mylabs and Altona which have approvals in India as imported kits are drying out. ICMR too is running out of adequate kits and reagents, so are private labs which have issues with importing." He thus added that rapid test kits would be therefore welcome as PCR kits are in short supply and indigenous players cannot scale up supplies immediately.

Big Indian players like Biocon too are in fray to develop the rapid antibody based kits. Speaking to Business Standard recently Biocon chairperson Kiran Shaw had indicated that Syngene, Biocon's research arm, is making efforts to develop antibody based test kits. She felt that these are more effective or accurate that the PCR tests - they can quickly tell three things, one whether you are infected or not, whether you are infected and recovering and whether you have recovered.

US giant Abbott has a small portable rapid testing kit that can deliver results in 5-10 minutes. The test is now available in the US and the company does not have any guidance on when this can be brought to India.