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.
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)
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