ShanMukha Innovations, a start-up incubated by the Society for Innovation and Development at 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,” said Prof. Sai Siva Gorthi, Principal Investigator, lead inventor of the technology.
The Central Drugs Standard Control Organisation had approved the manufacturing license for SickleCert kits for ShanMukha Innovations as a Class C in-vitro diagnostic medical device in November 2022.
In February this year, 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.
The startup said that the tests yielded an accuracy measure of 97.6%, with a sensitivity of 96.9% and a specificity of 98.6%.
The field studies also confirmed the operational feasibility of the tests for point of care use as well its cost effectiveness.
The formal Health Technology Assessment report is being compiled by the Department of Health Research and would be shared with the National Health Mission for updating the national guidelines for sickle-cell anemia, the start-up said.
Sickle-Cell Anemia 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.
As sickle cell anemia is an inherited condition, a person with sickle cell trait only inherits one defective gene, whereas people with the disease inherit two defective genes, one from each parent.
The Government of India has announced an ambitious National Sickle Cell Elimination Mission to eradicate the disease from the country by 2047 in the recent Budget. The Mission plans to screen seven crore people over the next three years as a first step.