Faulty Rapid Antibody Testing kits provided by two Chinese manufactures under ICMR scanner

Two Chinese manufactures of rapid antibody test, Guangzhou Wondfo Biotech Co., Ltd. and Zhuhai Livzon Diagnostics Inc are now the subject of investigations by the Indian Council of Medical Research (ICMR) as the much-touted, rapid testing antibody kits of these two compes delivered results with wide variations and low accuracy rates.

In a shock announcement during the daily health briefing held in New Delhi, which gives updates on India's effort against the COVID pandemic, ICMR announced that states had been advised to immediately pause tests using the rapid antibody kits for a period of 2 days, till ICMR completed its validation of these kits. Both these compes combined exported close to 7 Lakh kits to India.

"Chinese manufactures, Guangzhou Wondfo Biotech Co. provided about 5 lakh kits to India which was imported by 13 leading diagnostic firms in the country. Similarly, Zhuhai Livzon Diagnostics Inc. provided 2 lakh kits to four suppliers in India. Some kits of these two manufacturers have been found faulty by ICMR," an ICMR official informed on the condition of anonymity.

The apex medical research body recently received these rapid antibody testing kits from China through multiple sorties conducted by Air India and other commercial Indian jetliners and the active involvement of Indian Missions in these Chinese cities for urgent procuring of the kits. These kits were earmarked to map the trend or surveillance of Covid19 in a particular area or hotspot.

However, these tests were not to be used for diagnosis purposes.

On Tuesday, Dr. R Gangakhedkar, ICMR scientist informed: "States advised not to use rapid testing kits for two days. There is a lot of variations in the kits. Rapid antibody testing kits will be tested and validated by on-ground teams and will give advisory in the next 2 days."

Gangakhedkar added that this step has been taken after receiving a complaint from a state. "The rapid test kits have been distributed to states. In the last two days, we got several complaints from a state that these kits' results are not satisfactory. Now, we asked three more states and got to know that positive samples are showing a lot of variation -- from 6 per cent to 71 per cent. This is not a good thing," he said.

"We cannot ignore these findings. We have decided to send members from our eight institutes to the field in the next two days. The kits will be tested and validated by on-ground teams and we will give advisory in the next two days," he added.States like Madhya Pradesh, Rajasthan, Gujarat, and Maharastra have got the rapid testing kits and they had initiated testing through these kits, which are on pause pending ICMR approval.

Meanwhile, the Chinese Embassy in India's Spokesperson took note of media reports of the faulty testing kits and released a statement on Twitter addressing the issue. " Noticed reports concerning rapid testing kits. China attaches great importance to the quality of exported medical products. Will keep close communication with Indian concerned agency and provide necessary assistance," tweeted Ji Rong, Spokesperson for the Chinese Embassy in India.

This is not the first time that exports from Chinese medical compes have been found to be below standards. Earlier, in the month, similar reports of faulty Chinese testing kits emerged from Spain, Turkey, and the Netherlands. Last week a report in the New York Times said that the UK paid a massive sum of close to Rs190 Crore for Chinese Anti Body tests...a majority of those tests also turned out to be faulty.

( With inputs from ANI )

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