PathShodh Healthcare, a start-up incubated at the Society for Innovation and Development (SID), Indian Institute of Science (IISc), has developed a semi-quantitative electrochemical ELISA test for Covid-19 IgM and IgG antibodies.

PathShodh has received the licence to manufacture the test for sale from the Central Drugs Standard Control Organisation (CDSCO), after due diligence validation at the Translational Health Science and Technology Institute (THSTI), Faridabad, as per the requirements of the Indian Council of Medical Research (ICMR).

The novelty of the technology is based on the measurement of electrochemical redox activity of IgM and IgG antibodies specific to the SARS-CoV-2 Spike Glycoprotein (S1).

PathShodh’s technique, which is protected through US and Indian patent applications, is also a major departure from the qualitative rapid antibody tests in the market, which are primarily based on the lateral flow ELISA technique.

Funding

The funds for developing and commercialising this technology were provided by the Department of Science and Technology , under its initiative on Centre for Augmenting WAR with Covid-19 Health Crisis. The technology development was also supported by SINE at IIT Bombay and IKP Knowledge Park, Hyderabad. The Society for Innovation and Development (SID) at IISc provided the seed funding.

“The capability to quantify the Covid-19 antibody concentration will be crucial in estimating the declining antibody response over time and hence its possible impact on immunity against recurrence of infection. On a related note, this technique will also play a very big role in elucidating seroconversion response to Covid-19 vaccines, and thereby play a supporting role in vaccination programmes in the future,” said Navakanta Bhat, Dean, Division of Interdisciplinary Sciences and Professor, Centre for Nano Science and Engineering (CeNSE), IISc, who is also the co-founder of PathShodh Healthcare.

This test has been developed leveraging PathShodh’s Lab-on-Palm platform “anuPathTM”, which interfaces with disposable test strips functionalised with an immunoreceptor specific to Covid-19 antibodies. The results are automatically displayed by the handheld reader. The other unique features of this technology include on-board memory to store more than 1 lakh real-time test results, touch screen display, rechargeable battery, Bluetooth connectivity to smartphone and cloud storage, capabilities to map the patient data to Aadhar number and the possibility of connecting test data through APIs to Aarogya Setu.

According to Vinay Kumar, CEO and co-founder of PathShodh, “This novel technology can detect Covid-19 antibodies all the way down to the nanomolar concentration. It can work with venous or capillary (finger-prick) whole blood sample as well as serum sample. We plan to deploy the product in the market in the next couple of weeks. PathShodh’s current production capacity is about 1 lakh tests per month, and we can scale this up further by augmenting the manufacturing infrastructure.”