The ICMR on Wednesday issued guidance on rapid antibody test kits for COVID-19 and listed their manufacturers, which include two Chinese firms whose importer licenses were cancelled by the CDSCO after kits supplied by them showed wide-variation under field conditions.
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. The licences of Chinese companies Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics were cancelled by the Central Drugs Standard Control Organisation (CDSCO) last month. 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. Positive test indicates exposure to SARS-CoV-2 while 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.
The ICMR listed kits which were validated along with the batch number. Responsibility for batch to batch consistency lies with the manufacturer, it said. The Centre on April 27 had said it has "not lost a single rupee" with respect to the supplies of the COVID-19 rapid antibody test kits while cancelling the shipment of the equipment from two Chinese companies after those were found to be "under performing".
In an advisory sent to chief secretaries of all states and UTs, the ICMR had said it "evaluated the kits of Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics in field conditions. The results have shown wide variation in their sensitivity, despite early promise of good performance for surveillance purpose". The testing technique is used to detect antibodies in the blood of people who may have had coronavirus infection.