The licenses of Chinese companies Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics were canceled by the Central Drugs Standard Control Organization (CDSCO) last month.
The names of the two companies are mentioned among the companies whose test kits have been validated at NIV Pune so far.
The ICMR had previously said that such test kits should only be used for monitoring purposes.
According to Wednesday’s guidance, the ICMR stated that these tests can be performed on blood / serum / plasma samples whose results 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 testing indicates exposure to SARS-CoV-2, while negative testing does not rule out COVID-19 infection,” it said.
“These tests are not recommended for the diagnosis of COVID-19 infection,” the ICMR emphasized.
The Health Investigation Agency stated that to date, 42 antibody-based rapid tests have been validated at National Institute of Virology, Pune, and the following (list listed in the document) proved to be satisfactory, of which 10 are made in India.
“These rapid antibody test kits are validated in the laboratory. However, the performance of the kits may be subject to variation under field conditions,” the ICMR emphasized.
ICMR listed sets that were validated along with the batch number.
The responsibility for batch to batch consistency lies with the manufacturer, it said.
The center on April 27 said it “has not lost a single rupee” in terms of supplies of COVID-19 rapid antibody test kits while canceling the shipment of the equipment from two Chinese companies after it was found that they was in progress ”
In an advisory sent to top secretaries of all states and UTs, the ICMR said it “assessed the sets for Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics under field conditions. The results have shown wide variation in their sensitivity, despite an early promise of good performance for monitoring purposes. ”
The test technique is used to detect antibodies in the blood of people who may have had coronavirus infection.