New Delhi: Manufacturers of Chinese antibody testing kits for Covid-19 have said they are willing to cooperate in any investigation by the Indian Council of Medical Research (ICMR) into allegations of “malfunctioning”.
In press statements issued late Thursday, Guangzhou Wondfo Biotech Co Ltd and Zhuhai Livzon Diagnostics Inc, the two Chinese companies that have supplied the kits to India, also stated that users need to strictly follow the guidelines on “storage and stability”.
The clarification came days after India, Tuesday, briefly halted the use of antibody tests — a quick diagnostic tool that doesn’t require a laboratory and is being seen as key to easing lockdown restrictions — amid complaints of discrepant results. India is currently using rapid antibody tests from China, South Korea, Germany and France, alongside those from domestic manufacturers.
Expressing “shock” over reports of the rapid test kits malfunctioning, Livzon Diagnostics said, “We have shown great concern on this issue, and we are willing to coordinate with the related Indian government departments for investigation.”
The company added that the ICMR had placed orders with them after it was assured of their quality, saying the results yielded by the kits were also given a thumbs-up by the National Institute of Virology (NIV).
Wondo Biotech said it would “fully cooperate with the ICMR review and re-testing arrangements”. “Safety and product quality are our highest priorities,” it added.
The two companies, which are certified by the Chinese regulator National Medical Products Administration (NMPA), also stressed the need to follow the user manual when using the kits.
On 16 April, India received a total of 5.5 lakh rapid antibody testing kits from the Chinese companies — 3 lakh from Wondfo and 2.5 lakh from Livzon.
Two days later, on 18 April, a second batch of 3 lakh kits came in from China. All the kits were then distributed among the states.
The two firms noted that negative results from a rapid antibody test “do not rule out” infection, particularly for those who have been in contact with the virus, saying a conclusive diagnosis required follow-up antibody tests along with molecular testing.
Both companies noted that they had supplied testing kits to more than 70 countries and regions in Europe, Asia and Latin America, adding that certain authorised institutions in the US, Denmark and Sweden had evaluated the kits and come up with “excellent results”.
However, there have been reports from different countries, including the UK, about the failure of rapid diagnostic tests.
India to source more medical devices from China
The procurement of the testing kits was facilitated by the Indian Embassy in Beijing. The government plans to source more medical devices from China in the coming days, Indian Ambassador to China Vikram Misri had told ThePrint in an interview earlier this week.
“We are in touch with Chinese authorities regarding the procurement of the much needed medical equipment and products by our healthcare fraternity in India,” Misri had said.
“China happens to be the one of the largest producers of a number of these products.”
Over the past two weeks, around two dozen flights have departed for India from five cities in China carrying nearly 400 tonnes of medical supplies, including RT-PCR test kits, rapid antibody tests, PPE kits and thermometers among others.
“Around 20 more flights are expected to bring supplies from China in the coming days, and this is likely to be stepped up considerably in the next few months as our procurement efforts gain momentum,” Ministry of External Affairs spokesperson Anurag Srivastava had said Thursday.
Chinese Ambassador to India Sun Weidong tweeted Friday that China would “continue to support India fighting against Covid-19”.
China has opened “green channel” for Indian air cargo transport during the #epidemic and approved 35 cargo flights carring medical supplies such as PPEs, ventilators and testing kits to India in the need of the hour. We will continue to support India fighting against #COVID19.
— Sun Weidong (@China_Amb_India) April 24, 2020