New Delhi: The list of manufacturers of rapid antibody test kits, released by the ICMR, includes two Chinese firms whose importer licenses were cancelled by the Central Drugs Standard Control Organisation after kits supplied by them showed wide-variation under field conditions. Also Read - Delhi Airport Gears up as Domestic Flights Resume Today; No Quarantine For Asymptomatic Passengers
The apex health research body, however, in its guidance clearly stated that these rapid antibody tests are not recommended for diagnosis of COVID-19 infection. Also Read - First Flight From Delhi’s IGI Airport Lands at Pune as Domestic Air Travel Resumes After Two Months | LIVE Updates
The licences of Chinese companies Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics were cancelled by the Central Drugs Standard Control Organisation (CDSCO) last month. Also Read - Maharashtra Cabinet Minister And Former CM Ashok Chavan Tests Positive For COVID-19
The names of the two companies find a mention among the firms whose test kits have been validated at NIV Pune till now.
The ICMR earlier had said that such test kits are to be used only for surveillance purpose.
According to the guidance issued on Wednesday, the ICMR stated these tests can be done on blood/serum/plasma samples, the results of which are available within 30 minutes and the test comes positive after 7-10 days of infection.
“The test remains positive for several weeks after infection. A positive test indicates exposure to SARS-CoV-2 while the negative test does not rule out COVID-19 infection,” it said.
“These tests are not recommended for diagnosis of COVID-19 infection,” the ICMR stressed.
The health research body stated that till date, 42 antibody-based rapid tests have been validated at National Institute of Virology, Pune, and the following (list put out in the document) were found to be satisfactory, 10 of which are manufactured in India.
“These rapid antibody test kits have been validated in the laboratory. However, the performance of the kits may be subject to variation under field conditions,” the ICMR underlined.
The list of firms includes Abbott Laboratories Zydus Cadilla, HLL Lifecare Limited, India and SIDAK Life Care Pvt. Ltd among others besides Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics.
(With PTI Inputs)