The Spanish government admits it had to return 9,000 faulty rapid testing kits

MadridIn recent days there has been a growing controversy surrounding the rapid tests given out by the Spanish government for the detection of the coronavirus. On Thursday the Spanish government admitted that the first shipment from China, totalling 9,000 testing kits which were trialled in Madrid hospitals, failed to work effectively, eventually prompting a recall. Fernando Simón, Spain’s Director of the Centre for Coordination of Alerts and Emergencies, commented on the controversy following a story in Madrid daily El País which claimed that the initial batch of rapid tests supplied by the Chinese company Bioeasy have a sensitivity of only 30%, according to medical staff, when they ought to work in 80% of cases.

When the news came to light, the Chinese embassy in Madrid announced that Bioeasy does not have an official licence yet, adding that the latest massive batch of products purchased by the Spanish government has yet to leave China. In this instance, however, the products do meet the required standards. On Wednesday Spain’s Health Minister, Salvador Illa, announced the purchase of 5.5 million rapid tests from China. However, several days ago he announced the delivery of other rapid tests —also from Chinese— which were largely supplied to medical staff in Madrid, patients in a critical condition and the elderly in nursing homes.

Illa was speaking before the Congress of Deputies’ Health Commission at the request of the conservative opposition who sought to clarify the situation. The minister declared that the Chinese material was imported by a Spanish distributor which was considered "trustworthy", but that the quality control of the product had not given the desired result, meaning that the government had asked for the defective tests to be replaced. The minister justified the decision with the following assertion: "Imagine if we’d turned down 650,000 rapid tests. Would it have been better not to buy them? Now you’d be criticizing the government for letting an opportunity go by". Illa reiterated that the Spanish Medicines and Health Products Agency had no reason to be suspicious of the company, and sources close to the Moncloa added that business dealings with the manufacturer of the tests had the backing of the European Union. The faulty testing kits were part of an initial purchase of 659,000 units, 50,000 of which were never distributed, according to Illa.

Speaking of the tests, Simón stated that they had been "tested" by the National Centre for Epidemiology and also by hospitals in Madrid before being more widely used. He went on to say that the "tests showed that the specifications of the batch in question did not correspond with what was initially stated on their quality certification". This meant the shipment had to be returned, Simón declared, before adding that the company would exchange them and provide replacement tests. He did not name the firm involved, refusing to say whether it was Bioeasy, even when journalists insisted on the WhatsApp group used to send in questions which are then conveyed by the Secretary of State for Communication. The Moncloa subsequently revealed that Bioeasy was indeed the company involved in the faulty shipment, while providing copies of the documentation relating to their EC approval.

According to El País, several microbiology laboratories belonging to major hospitals have found that the new testing kits fail to detect as many positive cases as they ought to. The experts who studied the rapid tests made by the Chinese company Bioeasy concluded that they will have to continue to use the current test. This was confirmed by the Carlos III Health Institute, which is operated by the Ministry of Health.

Meanwhile, Simón stressed the importance of rapid tests, since they offer a "significant chance" of reducing the workload of labs, which are currently performing between 15,000 and 20,000 PCR tests a day, which is seen as the most reliable test. However, he said that "the most important point" was that Spanish biotech companies are working flat out to ensure that rapid tests will be manufactured in Spain "before long".

When questioned on this point, Foreign Minister Arancha González Laya stated in an interview with Radio Euskadi that all the material purchased by Spain met the "necessary quality standards". Pedro Sánchez’s government has paid €430 million for goods from two large suppliers who will guarantee the 5.5 million additional rapid tests, which Spain hopes will give a clearer picture of the spread of the disease. González Laya insisted that Spain has made sure "all the material: respirators, ventilators, gloves and rapid tests are approved, have the necessary quality certificates and are suited" to the Spanish health system.

A "war" to get supplies from China

Speaking in an interview with Telecinco, the spokesperson for the Spanish government, Maria Jesús Montero declared that, "it is an unknown market, there are many intermediaries offering bargains which are nothing of the sort. There are many speculators, including the intermediaries and the manufacturers themselves, which means it’s extremely important that, whatever one buys, one has to be very careful, so we don’t get caught out. Which is why we have chosen to buy with an eye to the future, to deal with a more stable group of companies in order to avoid the scams that flood the market". She went on to add that "we are engaged in a real war to obtain ventilators and rapid tests".

In an interview with ARA, Ramon Brugada, the head of cardiology at the Trueta Hospital in Girona, declared that although the tests provided by China are less reliable, they are much faster. They are used because they can detect some of the positive cases, although the negatives need to be re-tested with the current PCR tests. However, at present the Trueta Hospital has been unable to use the tests.