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The government will soon publish a finger-prick diagnostic test made in India for the detection of sickle cell anemia under the National Mission to Eliminate Sickle Cell Anemia.
With the aim of eliminating sickle cell anemia from India by 2047, the Indian Council of Medical Research (ICMR) has approved the first ‘Made in India’ sickle cell rapid test kit.
The mission aims to cover seven crore screening to identify people with sickle cell disease in the next three and a half years till the 2025-26 financial year.
Sickle cell disease (SCD) is an inherited blood disorder in which red blood cells become sickle-shaped. In this condition, the human body has trouble producing enough healthy red blood cells and undergoes numerous blood transfusions, which increases the chances of developing chronic infections.
The central and state governments will purchase the finger prick test kit – made by Maharashtra-based Voxtur Bio – to screen tribes and other vulnerable populations under the programme.
Similar to a pregnancy test kit, its ease of use and instant results (within 10 minutes) can help India achieve its goals faster. The device – unlike other tests available where samples are taken and sent to laboratories for evaluation – could be a game-changer in India’s battle against the genetic blood disorder.
“The rapid test kit saves time, eliminates the need for skilled manpower and additional resources required to draw blood, transport samples to laboratories and then produce reports later,” Dr. Veeraal Gandhi, Chairman and Managing Director, Voxtur Bio, told News18.
“With our test kit, results are available all the time without the need for skilled laboratory technicians and clinicians to interpret results.”
Also, the company claims to be the first to roll out Covid-19 antibody test kits or semi-quantitative ferritin test kits in India. “We were pioneers in the manufacture of rapid test kits. However, the sickle cell kit was developed by us in the shortest possible time,” said Gandhi, adding that his company started developing the kit in December and by March had already applied for a license.
In February, while presenting the Union Budget 2023, Finance Minister Nirmala Sitharaman also announced the mission of eradicating sickle cell anemia, which gives an additional impetus to the project.
How it works?
The group, which has been evaluated by ICMR, claims to have 100 percent privacy, sensitivity, and accuracy.
The kit is designed to diagnose four types of sickle cell conditions most common in India – sickle cell trait (HbAS), sickle cell disease (HbSS), HbC sickle cell disease (HbSC) and sickle cell HbCTrait (HbAC).
The kit works similar to a pregnancy test but requires two drops of blood (mixed with an assay) to be dispensed onto the tray on the test card.
“Within 10 minutes, a control bar will appear in front of any four attributes. If it does not appear, the test will be considered invalid,” Gandhi explained.
Thalassemia Test Kit Coming Soon
Gandhi, who is also the vice president of the Association of Diagnostic Manufacturers of India (ADMI), told News18 that his company is working on a similar product for another genetic blood disorder — thalassemia.
While he did not disclose more information about the product and expected launch timelines, Gandhi said that after Covid-19, diagnostics have moved from laboratories to homes.
“Now, the idea behind product development is to find a high-tech device that is more accessible to patients. In short, the industry is now working to streamline testing.”
In India, sickle cell rapid test kits will be sold to the centre. However, the company will export the product to other markets, including Africa, the Mediterranean regions, sub-Saharan regions, Central America, and other destinations.
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