India’s indigenous Monkeypox test kits ready, only government clearance is awaited

Molbio Diagnostic’s director said that the approval for test kits is expected soon from ICMR. (Creative commons)

“The Monkeypox test kit is ready. We have been approached by the Ministry of Health and have been asked to keep the documents ready for submission with the ICMR,” Molbio Diagnostics Founder and Director Sriram Natarajan told South First.

He expects the ICMR approval to come soon.

Awaiting approvals 

The company had begun its research and development (R&D) on a Monkeypox test kit as soon as the disease outbreak was reported in other countries.

“We are a multi-disease testing platform and whenever we see a new outbreak we start R&D. As the Monkeypox outbreak occurred in other countries and WHO confirmed its genome sequencing, we came up with the test kit,” Natarajan said.

Logo of India’s apex medical body, ICMR.

The test kits are, however, yet to be checked out in clinical samples.

“We have not had the access to carry out tests on clinical samples. We have informed the apex body in India, ICMR, about it and they have asked for documents, after which it will be taken up for approval,” Natarajan added.

Hitting the market

According to Natarajan, once the approval comes the company is confident of providing the minimum number of required test kits within a week or 10 days. “We can even expand the quantity if needed,” he added.

Though the Monkeypox outbreak may not be as severe as Covid-19 and might not need a large production of test kits, “the company is geared up for all situations”, he said.

Easily accessible

TrueNat real-time polymerase chain reaction is the world’s only point-of-care platform used by the World Health Organisation (WHO) to detect tuberculosis.

As there are around 5,000 machines being used even in remote areas across the country,  the approval will ensure access to the test kits.

Monkeypox samples. (Creative Commons)

The TrueNat platform comprises fully automated, battery-operated, rugged and portable machines that are ready-to-use at room temperatures. They use stable, long-shelf-life reagents and consumables.

Molbio’s TrueNat can test over 25 different diseases and over 30 additional diseases are said to be in the pipeline.

“The platform also has test kits ready for Nipah virus, cholera virus and several others. If there is any such outbreak we can immediately supply the test kits,” added Natarajan.