Bengaluru, May 19 (PTI): PathShodh Healthcare, a start- up incubated at the Society for Innovation and Development, Indian Institute of Science (IISc), said on Wednesday it has secured regulatory approval for semi-quantitative electrochemical ELISA test for COVID-19 IgM and IgG antibodies.
PathShodh said in a statement it has received the licence to manufacture the test for sale from the Central Drugs Standard Control Organisation after due diligence validation at the Translational Health Science and Technology Institute, Faridabad, as per the requirements of the Indian Council of Medical Research.
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), it said.
The S1 protein has a Receptor Binding Domain (RBD) which latches on to the ACE2 receptors on the host cells before infection, according the startup.
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.
PathShodhs 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, the statement said.
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', 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.
'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 Bhat.
This test has been developed by leveraging PathShodhsLab-on-Palmplatform anuPath, which interfaces with disposable test strips functionalised withan immunoreceptor specific toCOVID-19 antibodies.
The results are automatically displayed by the handheld reader.
Therefore, there are no subjective errors due to manual readout of test results, as in the current lateral flow assay test kits.
The other features of this technology include on-board memory to store more than one lakh real-time test results, touch screen display, rechargeable battery, Bluetooth connectivity to smart phone 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 technology can detect COVID-19 antibodies all the way down to the nanomolar concentration, and 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. PathShodhs current production capacity is about one lakh tests per month, and we can scale this up further by augmenting the manufacturing infrastructure,' he said.
PathShodh is also developing a COVID-19 rapid antigen test on the same platform.
'This could become a first-of-its-kind COVID-19 diagnostics solution with the capability to perform both rapid antibody and rapid antigen tests on a single platform,' it claimed.
The funds for developing and commercialising this technology were provided by the Department of Science and Technology, government of India, under its initiative on Centre for Augmenting WAR with COVID-19 Health Crisis (CAWACH).
The technology development was also supported by Society for Innovation & Entrepreneurship at IIT Bombay and IKP Knowledge Park, Hyderabad.
The Society for Innovation and Development at IISc provided the seed funding for this development, it was stated.
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