India’s first finger-prick COVID-19 diagnostic kit – Approved by ICMR
A simple finger-prick diagnostic test to detect COVID-19 antibodies in blood samples will be soon extensively available at nursing homes, hospitals as well as private labs. Anand Sekhri, CEO of Oscar Medicare, said that ICMR had authorized Delhi-based Oscar Medicare’s indigenous point-of-care (POC) rapid antibody test kits, which is possibly the only company to have got the funding from the Department of Biotechnology.
The failure of Chinese ‘faulty’ COVID-19 testing kits and government canceling their permits lead to the focus on the ‘gold standard’ RT-.PCR (real-time polymerase chain reaction) testing, and antigen screening. Specialists say that POC antibody tests have significance for emergency testing for diagnosis, specifically in remote areas, where laboratories may not be accessible and also could be hassle-free for people who feel uncomfortable with nasal swabs.
As antibody tests should not be used as the sole basis to diagnose the disease, the government has not yet permitted POC testing for COVID-19. Previously, ICMR had claimed there is a requirement to raise the outreach of testing by introducing rapid POC diagnostic tests.
Oscar Medicare is among the largest producers of pregnancy kits. Additionally, it manufactures diagnostic kits for
HIV, HCV, dengue, and malaria. Anand Sekhri said that they are intending to launch 2 lakh test kits in September, and have already consolidated with suppliers across the nation. The diagnostic kits have the highest levels – 98% level of sensitivity and 99% specificity to detect antibodies as well as the immune response to the virus. The test provides result in just 20 minutes, and the est is similar to that of a glucometer, which s used to detect diabetes.He added that if permitted by the government, this kit can even be used at home. The capacity of the company is to produce 5 lakh test kits daily, costing around Rs 200 per kit.
The company claims that Dhiti Life Sciences, a group company, produced the raw material, ‘Corona fusion antigen’ used in its test kits, a first in the country.
According to the experts from the industry, there are a few rapid POC kits out in the market and sold online. However, their integrity is under a cloud. Currently, private laboratories are using ELISA/CLIA (chemiluminescence immunoassay) technology with kits from Roche, Abbott, Siemens Healthineers, etc.
Rapid antibody blood tests depend upon disease prevalence. In reduced disease populations, outcomes of antibody tests might not be exact to make an informed decision whether or not an individual truly has antibodies to the virus or has had prior infection. There is a need to observe disease prevalence as well as the sensitivity of these kits, and afterward use them as a screening device, said Ajay Phadke, head at SRL-Dr Avinash Phadke Labs.
After validation of the 104 antibody-based rapid test, ICMR claimed on August 14 that these are not recommended for clinical diagnosis of COVID-19 or for registration of human subjects for any clinical tests. Till now the diagnostic kits of Voxtur Bio, VANGUARD Diagnostics, HLL Lifecare, Lab Care Diagnostics, NuLifecare have been accepted.
Dr. GSK Velu, CMD of Trivitron Medical Care said that, for COVID-19 screening, point-of-care testing has limited relevance as PCR as well as lab-based antibody tests are of the gold standard, and various other tests can also supplement in remote areas.
Central Drugs Standard Control Organisation had canceled the licenses of Chinese companies – Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics, and over quality problems, China’s Biomedomics and Korean firm, SD Biosensor were suspended in the month of May.
The experts added that the antibodies may not be detected in the early days of an infection when the body’s immune reaction is still developing. This restricts the test’s effectiveness for diagnosing COVID-19, and this is one-factor serology examinations should not be used as the sole basis to detect the diseases.
India’s first finger-prick COVID-19 diagnostic kit – Approved by ICMR
Author: Sruthi S
