A day after the Centre asked states to stop using the test kits procured from China to detect COVID-19, domestic manufacturers of rapid antibody test kits have approached the Indian Council of Medical Research (ICMR) to provide help for quick validation of their pilot and manufactured batches, The Economic Times has reported.
For this, the manufacturers have asked for known samples of COVID-19 positive patients and a dedicated testing body, said the report.
According to domestic diagnostic companies, they need access to inactivated known positive and negative samples of COVID-19 to build their own in-house panels. Once ready, these panels would become useful during the development and maintenance batch-to-batch consistency after manufacturing, the companies told the publication.
Every produced batch should be validated and approved by the National Institute of Virology (NIV) or an equivalent testing body before releasing into the market, domestic diagnostic companies said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
For testing, which is one of the key elements in fighting COVID-19, India procured around five lakh rapid antibody test kits from the two Chinese firms -- the Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics. However, the ICMR on April 27 asked states and union territories to stop using those test kits due to the "wide variations" in their performance.
Currently, there are nine Indian companies who have their antibody test kits validated by NIV, Pune, said the report.
In India, many IVD (in vitro diagnostic device) companies have the capability and capacity to develop and manufacture high-quality rapid card tests, Veena Kohli, managing director of Vanguard Diagnostics was quoted as saying.
Vanguard Diagnostics makes rapid kits used for the detection of antibodies and antigens — which are developed before the antibodies are formed — against dengue and malaria, the report suggested.
Union Health Minister Harsh Vardhan, on April 28, said the country would be self-reliant in producing RT-PCR and antibody testing kits by May-end that will enable it to conduct one lakh tests a day.
Out of at least half a dozen candidates (companies) supported for vaccines, four are in an advanced stage and regulatory platform at one place has been constituted for speedy clearances, he was quoted as saying in a statement.
(With inputs from PTI)Follow our full coverage on COVID-19 here.