The researchers at the Bengaluru-based Indian Institute of Science (IISc) have developed a new Covid-19 antibody test machine.
The IISc developed a semi-quantitative electrochemical ELISA test for Covid-19. The test can determine levels of Covid-induced IgM and IgG antibodies.
“PathShodh Healthcare, a start-up incubated at the Society for Innovation and Development (SID), Indian Institute of Science (IISc), has made a significant breakthrough in developing a first-of-its-kind, semi-quantitative electrochemical ELISA test for COVID-19 IgM and IgG antibodies,” IISc said in a statement.
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) – has issued a licence to manufacture the test for sale, and the scientists who are behind the project say they plan to deploy the product in the market in the next couple of weeks.
“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). 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,” the statement said.
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.”
This test has been developed by 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. Therefore, there are no subjective errors due to manual readout of test results, as in the current lateral flow assay test kits. 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 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.
“The capability to quantify the Covid-19 antibody concentration will be crucial in estimating the declining antibody response over time and hence it’s 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,” says Navakanta Bhat, Dean, Division of Interdisciplinary Sciences and Professor, Centre for Nano Science and Engineering (CeNSE), IISc.
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,” IISc said.