Home-based COVID-19 testing kits could soon be a reality with the Indian Institute of Technology (IIT) Delhi and the National Chemical Laboratory (NCL) Pune working on an alternative testing method which can not only be performed by individuals at home but will also deliver quick results.
The collaborative project with the NCL, which comes under the aegis of the Council of Scientific and Industrial Research (CSIR), has also received financial support from Microsoft India and is expected to be ready in a month's time.
According to the team, the project aims to develop an ELISA (Enzyme Linked Immunoassay) based diagnostic serological assay against COVID-19. If successful, it will create an economical, commercial process for manufacturing the antigens used in ELISA and home-based diagnostic kits to offer an effective, quick, robust and affordable diagnostic solution to manage the COVID-19 outbreak.
"Testing continues to be a challenge in managing COVID-19 and is likely to remain so for the years to come. Currently, Real-time Polymerase Chain Reaction (RT-PCR) tests detect genetic material to perform coronavirus testing. However, such tests can be performed in laboratories only, require several hours, have low rates of specificity and sensitivity and pose risks related to specimen collection and sample handling," Anurag S Rathore, Professor, IIT's Department of Chemical Engineering, told PTI.
"Additionally, these tests cannot be performed by individuals at home. These risks can be minimized by developing IgG and IgM based ELISA assays and home-based testing kits," he added.
IgG is the most abundant immunoglobulin to be produced in response to an antigen and is maintained in the body after initial exposure for long term response. IgM is the first immunoglobulin to be produced in response to an antigen and is primarily detected during the early onset of disease.
"Coronaviruses are composed of several proteins including the spike (S), envelope (E), membrane (M), and nucleocapsid (N). This assay we propose will utilizes the microplate-based enzyme immunoassay technique," said Rathore, who is also the institute's Dean, Corporate Relations.
"The technology for purposed ELISA assay for detection of coronavirus and robust and economical expression systems for production of N and S protein antigens can be transferred to national diagnostic centres and private companies specializing in developing home based kits or point-of-care devices, respectively," he added.
While Rathore did not comment on what will be the approximate cost of the test kit, he said, "it will be considerably cheaper than tests being performed now. However, we will have some concrete results in a month's time and we will be able to analyse only then".
IIT Delhi is the first academic institute in the country to get a nod from the Indian Council for Medical Research (ICMR) for its COVID-19 test kit. The institute has given non-exclusive open licence to Bengaluru-based biotechnology firm Genie Laboratories for commercialising the test, but with a price rider of Rs 500 per kit.
The kits are being manufactured at a facility at the Andhra Pradesh MedTech Zone (AMTZ) in Vishakhapatnam, and are expected to be available in the market next month.
According to the team, the current testing methods available are "probe-based" while the one developed by the IIT team is a "probe-free" method, which reduces the testing cost without compromising on accuracy.
Using comparative sequence analyses, the IITD team identified unique regions (short stretches of RNA sequences) in the COVID-19 and SARS COV-2 genome.
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