Given the information on the quality of the rapid tests, it is necessary to clarify that the Government, through the Ministry of Health, began several weeks ago the contacts with several companies for the acquisition of diagnostic tests, of which there are several systems in the market. The Government purchased a consignment from a domestic supplier, which imported them from China and whose product is CE marked.
Spain is guided by EU regulations and, therefore, if a product has European approval, it can be marketed and purchased throughout the community space.
Furthermore, by the Carlos III Health Institute (ISCIII) The documentation provided by the company regarding the clinical studies carried out by the Chinese manufacturer was analyzed. It was also verified that there was no alert from the Spanish Agency for Medicines and Health Products (AEMPS) about this product.
The first tests of the rapid test were carried out in parallel in a Madrid hospital and in the ISCIII and as soon as a low sensitivity was detected, an immediate order to withdraw was given; and the supplier who is going to replace it with another type of test was contacted.
This operation, which is not related to the purchase of medical supplies announced yesterday by Minister Salvador Illa, began before the Chinese authorities provided new lists of their suppliers to the Government of Spain. However, those listings include preferred and validated manufacturers. In no case is there any information about the Chinese company that, according to the embassy, does not yet have the corresponding license in China.
The Ministry of Health did verify the reliability of the national supplier.