Defective Antibody Rapid Test Kits Provided by Two Chinese Manufacturers with ICMR Scanner | India News



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NEW DELHI: Two Chinese rapid antibody test manufacturers, Guangzhou Wondfo Biotech Co., Ltd. and Zhuhai Livzon Diagnostics Inc are now under investigation by the Indian Council of Medical Research (ICMR) as the most rapid antibody test kits Promoted from these two companies obtained results with wide variations and low precision rates.
In a surprising announcement during the daily health briefing in New Delhi, providing updates on India’s effort against the COVID pandemic, ICMR announced that states had been advised to immediately stop testing using the kits. Rapid antibodies over a 2 day period, until ICMR completed their validation of these kits. Both companies combined exported about 7 Lakh kits to India.
“Chinese manufactures, Guangzhou Wondfo Biotech Co. provided around 5 lakh kits to India, 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 from these two manufacturers have been found defective by ICMR, “an ICMR official told ANI on condition of anonymity.
The Apex Medical Research Agency recently received these China Rapid Antibody Test Kits through multiple departures by Air India and other Indian commercial aircraft and the active involvement of Indian missions in these Chinese cities for the urgent acquisition of kits. These kits were assigned to map the trend or vigilance of Covid19 in a particular area or access point.
However, these tests were not used for diagnostic purposes. On Tuesday, Dr. R Gangakhedkar, an ICMR scientist reported: “States advised against using rapid test kits for two days. There are many variations on the kits. Test teams will test and validate antibody rapid test kits and advise in the next 2 days. ”
Gangakhedkar added that this step has been taken after receiving a complaint from a state. “Rapid Test Kits have been distributed to states. Over the past two days, we received several complaints from one state that the results of these kits are not satisfactory. Now we asked three more states and came to know that the samples Positive shows a lot of variation, from 6% to 71%. This is not a good thing, “he said.
“We cannot ignore these findings. We have decided to send members of our eight institutes to the field in the next two days. The equipment will be tested and validated by the teams on the ground and we will give advice in the next two days.” added. States such as Madhya Pradesh, Rajasthan, Gujarat and Maharastra obtained the rapid test kits and started testing through these kits, which are paused pending ICMR approval.
Meanwhile, the spokesman for the Chinese Embassy in India noted media reports about the faulty test kits and issued a statement on Twitter addressing the problem. “Reports noted on rapid test kits. China attaches great importance to the quality of exported medical products. It will maintain close communication with the Indian agency concerned and provide the necessary assistance,” Ji Rong, spokesman for the Chinese embassy in India, tweeted.
This is not the first time that exports by Chinese medical companies have fallen below standards. Earlier in the month, similar reports of faulty Chinese test kits emerged from Spain, Turkey, and the Netherlands. Last week, a report in the New York Times said the UK paid a massive sum of about Rs190 Crore for tests against the Chinese body … most of those tests also turned out to be flawed.
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