New Delhi: Hours after India received 5 lakh rapid antibody test kits from China, India's apex medical research institute, Indian Council of Medical Research (ICMR) on Thursday evening issued guidelines on the use of these kits.
The ICMR has pointed out that these tests are not recommended for diagnosis of COVID-19 infection.
Officials in ICMR told ETV Bharat that till date, 23 antibody-based rapid test has been validated at NIV, Pune and 14 were found to be satisfactory.
These will be used for understanding the COVID-19 trend and not for diagnosing the infection, it said, insisting India was conducting enough tests as “24 people are tested for one positive case”.
“The kits are not for early diagnosis because antibodies will be visible only in 80 per cent of patients… But it will help us in finding if the infection is increasing or decreasing in hotspots,” said Raman R Gangakhedkar, head scientist, ICMR.
Nine of the test kits are manufactured in India including New Coronavirus (Covid19) IgG/IgM Rapid Test: Voxtur Bio Ltd, India, Make sure COVID-19 Rapid Test: HLL Lifecare Limited, India among others.
India on Thursday received 5 lakh rapid antibody test kits from two different companies in China including Wondfo Biotech Company, Zhuhai and Livzon Diagnostic Inc, Shenzen.
Interestingly, NIV-Pune has also validated 31 real-time PCR kits for the detection of SARS-CoV-2 RNA.
"As many as 14 kits have been found validated. All these kits are also approved by US-FDA."
Meanwhile, ICMR and its laboratories have tested a total of 3,02,956 samples and out of which 12,581 have been confirmed COVID-19 positive.
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