Chinese firm to replace ‘unreliable’ Covid-19 rapid test kits sent to Spain
- Shenzhen Bioeasy Biotechnology will ship new kits to make sure ‘patients get the best diagnostics’; manager dismisses reports as ‘untrue’
- It comes after Spanish research institute said it found nose swabs developed by the company had an accuracy rate of less than 30 per cent
In a statement addressed to Spain’s Ministry of Health on Friday, Shenzhen Bioeasy Biotechnology said it would send new kits to make sure “patients get the best diagnostics” and to “ensure the test kits’ sensitivity and specificity”.
“As it [is a] rapid test kit, following the protocol is very important,” the company added.
It came after the Spanish Society of Infectious Diseases and Clinical Microbiology, one of Spain’s leading research institutes, posted on its website that it had found nose swabs developed by the Chinese company had an accuracy rate of less than 30 per cent.
Spanish daily El País reported earlier that the country had ordered 340,000 test kits from the company, and that Madrid’s city government had decided to stop using the Bioeasy kits.
Spain’s health ministry said it had asked the national supplier to replace the test kits.
“The government purchased the products from a national supplier, which were imported from China and CE marked,” the health ministry said in a statement on Thursday, referring to the certification marking showing a product meets the health, safety and environmental protection requirements to be sold in the European Union.
“The Ministry of Health verified the reliability of the national supplier,” it added.
An EC declaration of conformity signed by the Shenzhen-based company – stating its products met the CE requirements – was attached to the statement.
Bioeasy manager Zhu Hai on Friday dismissed as “untrue” reports suggesting the company’s test kits had a low accuracy rate, telling the South China Morning Post that a more detailed explanation would be given via official Chinese government channels.
In its statement, the company also emphasised that its test kits were up to standard.
“The production export of our CE products to Spain has been done according [to] regulations,” the statement said. “All Bioeasy Covid-19 rapid test [kits] are officially CE-IVD approved, so we are free to [export] and sell in [the EU].”
IVD refers to in vitro diagnostic medical devices.
The company also said it had exported more than 420,000 test kits to at least 10 countries, including Italy, Qatar and Ukraine. In particular, it had exported 337,000 tests to South Korea, with another 5 million under production.
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