Faulty Chinese kits part of ICMR list, may be removed

Rapid testing kits by two Chinese corporations that had been discovered defective final month had been included in a revised checklist of kits authorised by the Indian Council of Medical Research (ICMR) on Wednesday however the apex analysis physique mentioned it was dropping the 2 corporations.

The Covid-19 IgM/IgG antibody speedy test package from Zhuhai Livzon Diagnostics (CEIVD) and SARS-CoV-2 antibody test (Lateral circulation technique) from Guangzhou Wondfo Biotech had been discovered to be displaying unusually excessive variations of their ends in varied states. The apex analysis physique had prohibited their use.

The ICMR mentioned all 15 kits validated by the National Institute of Virology in Pune had been 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,” mentioned Dr Rajnikant Srivastava, spokesperson, ICMR.

The physique additionally put a disclaimer within the doc, 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 corporations to states on April 21, ICMR had requested states to not use them after unusually excessive variations (between 6 and 71%) had been seen in subject settings. After a week-long investigation, on April 27, ICMR had prohibited their use. The import license of those two corporations was additionally cancelled by the Central Drugs Standards Control Organisation quickly after.