India's first-ever sickle-cell anaemia diagnostic kit was unveiled on Monday by a Bengaluru-based technology start-up, a company statement said.
The technology, developed by ShanMukha Innovations, a start-up incubated by the Society for Innovation and Development (SID) at the Indian Institute of Science (IISc), provides an affordable and efficient solution to screen large populations as a point of care test for sickle-cell anaemia.
The technology called High Performance Optical Spectroscopy (HPOS) consisting of test kits (SickleCert) and portable analyzer (HaemoCube) was developed by researchers at IISc, the statement said.
"With a tiny amount of blood from a finger prick, the test provides highly accurate results in 15 minutes," says Sai Siva Gorthi, Principal Investigator and Associate Professor at the Instrumentation and Applied Physics Department, IISc.
Gorthi, the lead inventor of the technology, said over 40 samples can be tested in an hour in batch mode, enabling a large volume of screenings to be completed in a much shorter time span.
A companion smartphone application enables digital data recording, analysis and integration with various registries, Ayushman Bharat Health Account (ABHA) and other cloud-based patient health record systems.
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The tests yielded an accuracy measure of 97.6 per cent, with a sensitivity of 96.9 per cent and a specificity of 98.6 per cent, the company statement said.
Sickle-cell anaemia is caused by a defective gene, Haemoglobin S, which causes flexible red blood cells to become stiff sickle-shaped cells, obstructing blood flow and increasing the risk of organ damage.
"This solution is a shining example of collaboration between IISc, ShanMukha Innovations, ICMR, DHR, CDSCO and the Ministry of Health to nurture an indigenous technology and shape it to align with the National Mission," said Arun B, Director, ShanMukha Innovations.
The Central Drugs Standard Control Organisation (CDSCO) had approved the manufacturing licence for SickleCert kits for ShanMukha Innovations Pvt Ltd as a Class C in-vitro diagnostic medical device in November last year.
In February, multi-centric field studies were successfully carried out as prescribed by the Indian Council of Medical Research (ICMR) across tribal districts in Madhya Pradesh and Maharashtra.
Earlier this month, Union Finance Minister Nirmala Sitharaman announced a mission to eliminate sickle-cell anaemia by 2047.
"The mission will entail awareness creation, universal screening of seven crore people in the age group of 0-40 years in effective tribal areas and counselling through collaborative efforts of central ministries and state governments," Sitharaman had said in her Budget speech.
The disease is prevalent in tribal and general populations in Maharashtra, Madhya Pradesh, Chhattisgarh and Odisha.
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