Rapid testing kits by two Chinese companies that were found faulty last month were included in a revised list of kits approved by the Indian Council of Medical Research (ICMR) on Wednesday but the apex research body said it was looking at dropping the two firms.
The Covid-19 IgM/IgG antibody rapid test kit from Zhuhai Livzon Diagnostics (CEIVD) and SARS-CoV-2 antibody test (Lateral flow method) from Guangzhou Wondfo Biotech were found to be showing unusually high variations in their results in various states. The apex research body had prohibited their use.
The ICMR said all 15 kits validated by the National Institute of Virology in Pune were included.
“We are looking at getting the names of the two companies dropped from the list to avoid any confusion. However, the sensitivity and specificity of a test kit varies from batch to batch which is why lot testing is done for quality assurance. As we have said these kits are not meant for diagnostic purposes and can show variation in the field settings,” said Dr Rajnikant Srivastava, spokesperson, ICMR.
The body also put a disclaimer in the document, saying “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. Above listed kits are validated with the mentioned batch number only. Responsibility for batch to batch consistency lies with the manufacturer.”
Four days after procuring and distributing kits from these two companies to states on April 21, ICMR had asked states to not use them after unusually high variations (between 6 and 71%) were seen in field settings. After a week-long investigation, on April 27, ICMR had prohibited their use. The import license of these two companies was also cancelled by the Central Drugs Standards Control Organisation soon after.
