DST funded start-up's ELISA test to make better estimation of COVID antibody concentration

Ministry of Science and Technology (MoST) on Saturday, May 22, said, a technology backed by the Department of Science and Technology (DST), the Electrochemical ELISA test, allows quick and accurate estimation of COVID-19 antibody concentration in clinical samples. A Bengaluru-based start-up designed a novel, point-of-care Electrochemical ELISA test that enables quick and accurate estimation of total antibody concentration of COVID 19 in clinical samples, according to the ministry. The results are available in five minutes using the handheld computer.

The ministry said, "PathShodh Healthcare, the start-up incubated at the Society for Innovation and Development (SID), Indian Institute of Science (IISc), has made a very significant breakthrough to develop the first of its kind, semi-quantitative Electrochemical ELISA test for COVID-19 IgM and IgG antibodies. While Qualitative analysis detects constituent elements in the sample, the semiquantitative analysis gives an approximate estimation of their concentrations. PathShodh has received the license to manufacture for sale from the Central Drugs Standard Control Organisation (CDSCO), after validation at Translational Health Science and Technology Institute (THSTI), Faridabad, as per the requirements of Indian Council of Medical Research (ICMR)."

Electrochemical ELISA test for faster COVID result

The technology's novelty, according to the ministry, is focused on the measurement of IgM and IgG antibodies unique to SARS-CoV-2 Spike Glycoprotein electrochemical redox activity (S1). The Receptor Binding Domain (RBD) of the S1 protein binds to the ACE2 receptors on the cells prior to infection. As a result, when compared to other antibody tests targeting Nucleocapsid (N) protein, antibody tests targeting S1 spike protein are more indicative of an immune response to infection.

The ministry noted, "PathShodh's technique is also a major departure from the qualitative rapid antibody tests in the market, which are primarily based on lateral flow ELISA technique. The technology has been protected through US and Indian patent applications." 

Prof. Navakanta Bhat, Dean, Division of Interdisciplinary Sciences and Professor, Centre for Nano Science and Engineering, IISc, who is also the co-founder of PathShodh Healthcare, explained, "The capability to quantify the COVID-19 antibody concentration will be very crucial in estimating the temporal decay of antibodies, 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 programs in future."

The test kit is divided into two parts. The first is a handheld analyzer that reads a blood sample and generates a comprehensive report. The other is a test strip, which is used to inject a drop of blood from one's fingertip into the instrument. The results of the portable device are available in five minutes and can be downloaded to your mobile phone.

COVID-19 testing device

The statement added, "It has been developed, leveraging PathShodh's Lab-on-Palm platform "anuPathTM", which interfaces with disposable test strips functionalized with immunoreceptors specific to COVID-19 antibodies. As the results are automatically displayed by the handheld reader, there are no subjective errors due to the manual readout of test results. The other unique features of this technology include onboard 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."

The method is helpful not only as a regular serosurvey device to establish prior infection, but also as a quantifier of antibodies to tackle such critical questions as the rate of fading of antibodies, and in particular, understanding of biological responses that are dependent on the number of antibodies, such as vaccine efficacy, said Ashutosh Sharma, Secretary, DST. 

"This novel technology can detect the COVID-19 antibodies all the way down to 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," said Dr Vinay Kumar, CEO, and co-founder of PathShodh. 

(with inputs from ANI)

Picture Credit: @PIB_India