A COVID-19 test developed by PathShodh Healthcare, a start-up incubated on the Society for Innovation and Development (SID), Indian Institute of Science (IISc),
has obtained the license to fabricate the test for sale from the Central Drugs Standard Control Organisation (CDSCO).
The test is touted to be the first-of-its-kind, semi-quantitative electrochemical ELISA test for COVID-19 IgM and IgG antibodies, obtained the licence after due diligence validation on the Translational Health Science and Technology Institute (THSTI), Faridabad, as per the necessities of the Indian Council of Medical Research (ICMR), an IISc launch mentioned.
According to the discharge, the novelty of the know-how is predicated on the measurement of electrochemical redox exercise of IgM and IgG antibodies particular to the SARS-CoV-2 Spike Glycoprotein (S1). “The S1 protein has a Receptor Binding Domain (RBD) which latches on to the ACE2 receptors on the host cells before infection. Hence, antibody tests targeting the S1 spike protein are more representative of immune response against infection compared to those that target the Nucleocapsid (N) protein,” it defined.
PathShodh’s approach, which is protected by way of US and Indian patent purposes, can be a serious departure from the qualitative speedy antibody assessments out there, that are based on the lateral stream ELISA approach, it added.
“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. 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,” the discharge quoted Navakanta Bhat, Dean, Division of Interdisciplinary Sciences and Professor, Centre for Nano Science and Engineering (CeNSE), IISc, and co-founder of PathShodh Healthcare, as saying.
Vinay Kumar, CEO and co-founder of PathShodh, mentioned, “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.”
The test has been developed by leveraging PathShodh’s Lab-on-Palm platform “anuPathTM”, which interfaces with disposable test strips functionalised with an immunoreceptor particular to COVID-19 antibodies. The outcomes are mechanically displayed by the hand-held reader, eliminating subjective errors as a consequence of guide readout of test outcomes. The different distinctive options of this know-how embody on-board reminiscence to retailer greater than 1 lakh real-time test outcomes, contact display screen show, rechargeable battery, Bluetooth connectivity to good cellphone and cloud storage, capabilities to map the affected person information to Aadhaar quantity and the opportunity of connecting test information by way of APIs to Aarogya Setu, the IISc launch mentioned.
PathShodh Healthcare is an ISO 13485 licensed firm, the primary start-up from IISc to get this certification. The firm can be growing a COVID-19 speedy antigen test on the identical platform. This might turn out to be a first-of-its-kind COVID-19 diagnostics resolution with the potential to carry out each speedy antibody and speedy antigen assessments on a single platform. The funds for growing and commercialising this know-how had been offered by the Department of Science and Technology (DST), Government of India, underneath its initiative on Centre for Augmenting WAR with COVID-19 Health Crisis (CAWACH). The know-how improvement was additionally supported by SINE at IIT Bombay and IKP Knowledge Park, Hyderabad. The Society for Innovation and Development at IISc offered the seed funding for this improvement, the discharge mentioned.
