SPAIN has ordered 600,000 rapid coronavirus testing kits from a Chinese manufacturer that ‘no licence’ to sell medical products.
The tests also ‘don’t meet the specifications given by the European Commission’, confirmed Fernando Simon – director of Spain’s Centre for Coordination of Medical Alerts and Emergencies.
A sample 9,000 of the new kits were tested at hospitals and the National Centre of Microbiology in Madrid following the arrival of Spain’s first batch of its order last Saturday.
Preliminary trials revealed the rapid tests have a sensitivity of under 30%, according to the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC).
This means that if 10 people with coronavirus take the test, seven will be false negatives.
The existing coronavirus test, termed PCR, has a sensitivity of 84%.
PCR testing takes up to four hours and requires qualified personnel and specialised laboratories to carry out. The government will U-turn on its plans to buy 6 million of the ‘rapid’ tests intended to be distributed nationwide.
“We have returned the tests and are expecting new ones,” Simon added.
It comes as the Chinese Embassy in Spain has Tweeted that Shenzen Bioeasy Technology ‘does not yet have an official licence’ to sell medical products in China.
The ‘high-tech enterprise’ manufacturing in the field of clinical diagnosis advertisers its Bioeasy Test Kits on its website with no warning about the company’s lack of authorisation.
The company has not yet responded to a request for comment.
The World Health Organisation (WHO) has urged testing is vital for control of the virus by isolating those infected as soon as possible.