ICMR puts domestic and foreign made COVID-19 testing kits under scanner

Due to the complaints received by states over the faultiness of COVID-19 testing kits from China, ICMR on Wednesday decided to put testing on hold for two days.

New Delhi: The Indian Council of Medical Research (ICMR) has kept imported RT-PCR, rapid (antibody) testing kits from China and indigenously manufactured COVID-19 testing kits under the scanner, a source said.

Officials from ICMR on Wednesday told ETV Bharat that the department will take a call on whether these kits will be used or not, only after it receives a report from its team on grounds.

The faulty kits for COVID-19 testing have posed a problem for the central government, the Union Health Ministry has scaled up rapid testing for all Influenza Like Illness (ILI) and Severe Acute Respiratory Illness (SARI) patients as India comes close to the end of a 40 days lockdown period.

However, on Monday, ICMR got a compliant from West Bengal over the faulty testing kits. On receiving the similar feedback of faultiness from three other states on Tuesday, it decided to put testing on hold for two days.

ICMR procured the testing kits from two Chinese vendors based in China namely Guangzhou Wondfo Biotech Co. Ltd. and Zhuhai Livzoh Diagnostics Inc.

"Too many variations have been reported in results of rapid (antibody) test kits and RT-PCR (reverse transcription-polymerase chain reaction) test kits, the variation in detection of RT-PCR positive cases varies from 6 percent to 71 percent," said Dr Ratan R Gangakhedkar. The kits are US-FDA approved. Significantly, India at present has 77 domestic manufacturers for such test kits and for PPEs.

"We are also examining the domestically manufactured test kits," officials said.

Complaints regarding Chinese kits were earlier reported in several other countries including Spain and the Netherlands.

Reportedly, 5 lakh testing kits came from China last week and many more batches of kits are expected in the coming days. Further, while addressing a press briefing after a cabinet meeting on Wednesday afternoon, Union Minister Prakash Jawdekar said that ICMR has forwarded a protocol for using Rapid antibody test to all states. Later, ICMR in a statement said that antibody rapid test are largely to be used as a tool for surveillance.

"Globally also the utility of this test is evolving and it is currently being used for detecting and the formation of antibodies in individuals. These tests result are also dependent on field conditions," the ICMR said. It further said that as noted by ICMR this antibody test cannot replace the RT-PCR test to diagnose COVID-19 cases.

"ICMR has assured assistance to collect data from various states to assess the scope and extent of the utility of these rapid antibody test in field conditions and ICMR shall keep advising the state on a regular basis. States have also been advised to follow the prescribed protocol for this test and used for the purpose for which they are meant," the ICMR said.

As on Tuesday, a total of 4,62,621 samples have been tested across India, ICMR said.