There are two types of tests being conducted in India to determine whether a person is COVID-19 positive — the antigen test, which includes the RT-PCR (Reverse-Transcription Polymerase Chain Reaction) test, and the antibody test, where blood samples are checked for antibodies that fight the viral infection.
The antibody test helps to identify the presence of antibodies even in asymptomatic individuals who otherwise do not show any signs of infection.
A few months after recovering from COVID-19, the same test can be conducted to determine the antibody count in the patient. With the ongoing vaccine drive, the test can also help to identify an individual’s immune response before and after taking the doses.
“But, there are only two types of facilities available to conduct these tests. One is a semi-quantitative test available at the lab level. This shows the exact values of the antibodies. However, the equipment required to conduct the test is very expensive and cannot be moved to remote locations. The second type of test is the lateral flow Enzyme-Linked Immunosorbent Assay (ELISA) technique, which is like a pregnancy test kit that is easily accessible. Here, the results are qualitative and only determine whether antibodies are present or not,” says Navakanta Bhat, the co-founder of PathShodh Healthcare, an IISc (Indian Institute of Science), Bengaluru, incubated startup.
As a middle ground, Navakanta, along with Vinay Kumar — the other co-founder of the company, has launched an antibody test kit that provides semi-quantitative—or estimated amounts of antibodies present—results within five minutes and is portable, like a glucose test kit.
In an interview with The Better India, they share how the test kits were developed and approved for sale.
Innovating the solution
Intending to develop an affordable solution, in June 2020, the duo started researching and developing the device.
By the end of the year, they developed a test kit that comes in two parts. One is the handheld analyser which reads the blood sample and gives a detailed report. The other is a test strip where a drop of blood from one’s fingertip is inserted into the device.
“The technology of the device is based on the measurement of electrochemical redox activity of antibodies specific to the coronavirus. The handheld device provides the results within five minutes, the results of which can be downloaded on your mobile phone. The analyser works on a rechargeable battery and can store up to 1 lakh real-time test results,” says Navakanta.
Once the working prototype was finalised, it was sent to four labs across Bengaluru where over 500 samples were tested. Then it underwent an independent validation test at Transitional Health Science and Technology Institute in Faridabad, a lab recognised by Indian Council of Medical Research (ICMR).
“Here the tests are conducted alongside already existing methods to check its effectiveness. Finally, there was a testing audit done by the Central Drugs Standard Control Organisation (CDSCO),” says Navakanta, adding that they have also received approval and a manufacturing license from the CDSCO.
The team will begin the manufacture and sale of the test kits from next week. According to Vinay, PathShodh Healthcare has a manufacturing capacity of 1 lakh units per day. However, it can be scaled up by augmenting the infrastructure.
This first-of-its-kind COVID-19 test will be priced below Rs 500 and the devices can be procured by hospitals, clinics and doctors.
To know more visit the official website.
Edited by Yoshita Rao