ShanMukha Innovations, a start-up incubated by the Society for Innovation and Development on the Indian Institute of Science (IISc), has developed SickleCert, India’s first indigenous diagnostic kit for Sickle-Cell Anemia.
“The technology we have developed provides an affordable and efficient solution to screen large populations as a point of care test. With a tiny amount of blood from a finger prick, the test provides highly accurate results in 15 minutes. In batch mode over 40 samples can be tested in an hour enabling a large volume of screenings to be completed in a much shorter time span,” mentioned Prof. Sai Siva Gorthi, Principal Investigator, lead inventor of the expertise.
The Central Drugs Standard Control Organisation had authorized the manufacturing license for SickleCert kits for ShanMukha Innovations as a Class C in-vitro diagnostic medical system in November 2022.
In February this yr, multi-centric subject research have been efficiently carried out as prescribed by the Indian Council of Medical Research (ICMR) throughout tribal districts in Madhya Pradesh and Maharashtra.
The startup mentioned that the checks yielded an accuracy measure of 97.6%, with a sensitivity of 96.9% and a specificity of 98.6%.
The subject research additionally confirmed the operational feasibility of the checks for level of care use as effectively its value effectiveness.
The formal Health Technology Assessment report is being compiled by the Department of Health Research and could be shared with the National Health Mission for updating the nationwide pointers for sickle-cell anemia, the start-up mentioned.
Sickle-Cell Anemia is attributable to a faulty gene, Haemoglobin S, which causes versatile pink blood cells to turn into stiff sickle-shaped cells, obstructing blood movement and rising the chance of organ injury.
As sickle cell anemia is an inherited situation, an individual with sickle cell trait solely inherits one faulty gene, whereas individuals with the illness inherit two faulty genes, one from every mother or father.
The Government of India has introduced an bold National Sickle Cell Elimination Mission to eradicate the illness from the nation by 2047 within the current Budget. The Mission plans to display screen seven crore individuals over the following three years as a first step.