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ICMR scientist develops world’s first rapid, cost-effective kits to diagnose haemophilia, von Willebrand disease

This simple strip-based test can be performed at a Primary Healthcare Centre. It holds the potential to change the diagnostic landscape of bleeding disorders like haemophilia and von Willebrand disease (vWD), not only in India but in several other developing countries, which either lack proper diagnostic facilities or where existing facilities are not up to acceptable standards

April 26, 2022 / 08:09 PM IST
Representative image.

Representative image.

For the first time, scientists at ICMR-National Institute of Immunohaematology, Mumbai, have developed simple, rapid and cost-effective diagnostic kits for the diagnosis of haemophilia and von Willebrand disease (vWD).

These low-cost, Make In India kits can be used effectively even in Primary Healthcare Centres, where diagnosis can be offered without the need for skilled technical personnel or expensive equipment.

It is estimated that India is home to one lakh haemophilia patients.

Both these blood-related diseases require specialised laboratories and trained manpower for diagnosis, and these tests are available only at a few tertiary-level hospitals.

Dr Bipin P. Kulkarni, of NIIH, Mumbai, spoke to Moneycontrol on this path-breaking invention. Edited excerpts:

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Congratulations on the invention. Please tell us more about it?

These are point-of-care kits, which can detect bleeding disorders -- haemophilia and von Willebrand disease (vWD) disease. There are two separate kits that have been designed for these two diseases, and both kits work on the same principle. This entire project is the brainchild of Dr. Shrimati Shetty, who was working as principal investigator previously; now she has retired.

What was the need for such kits?

For conventional diagnosis of haemophilia and vWD, the patient needed to visit a laboratory; these are not common laboratories, but are specialised laboratories that undertake detailed investigation of haemophilia and vWD.

In the conventional setting, it requires trained laboratory staff and equipment to diagnose these diseases, and involves a decent cost too. These facilities are not available in the remote areas of our country. Why only India, it won’t be available in any third world country.

Patients have to travel long distances just for diagnosis, and then for follow up. This is a genetic disorder. So, once a patient is born with this disease, it will be there for the entire life. So, for the patient if the laboratory is not in the locality, it becomes a real problem.

What is the process of using these diagnostic kits? And how soon can they provide the results compared to a laboratory?

On a small strip, 2 micro litre blood plasma sample needs to be dropped to test for haemophilia, vWD. Within 10 minutes you can get the results. Even in a laboratory setting, the investigation can take 2-3 hours. These kits help in differentiating between haemophilia and vWD. That makes the treatment easy. Conventional tests could cost between Rs. 2,000 to Rs. 9,000.

Tell us about the MoU signed with companies, and how soon can these kits be available in the market?

After going through all the procedures laid down by the IPR Department, ICMR has collaborated with Bhat Bio-Tech India (P) Ltd (BBI), Bangalore, for commercialisation of these kits. Before transferring the technology to BBI, we have conducted complete clinical studies on haemophilia and vWD Rapid Card Test kits and the kits have successfully passed all study parameters. The firm has recently been granted manufacturing license by DCGI. The kits are expected to enter the market in the next 3-4 months.



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Ayushman Kumar Ayushman covers health and pharma for MoneyControl
first published: Apr 26, 2022 08:07 pm
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