Spanish health authorities said on Thursday that they have returned a shipment of rapid diagnostic tests purchased from a Chinese manufacturer after these were found to be unreliable in detecting the SARS-CoV-2 coronavirus.
Health Minister Salvador Illa said the government has sent the tests back to a company named Shengzhen Bioeasy Biotechnology after Spanish microbiologists reported that the first 9,000 tests correctly identified positive cases only 30% of the time, when experts recommend a sensitivity of at least 80%. The story was first reported by EL PAÍS on Wednesday, and the Health Ministry has since confirmed it.
The discovery will further delay attempts at testing a larger segment of the population in order to detect and isolate positive cases and slow down the pace of transmission, following World Health Organization (WHO) guidelines.
Spain is now second in the world in number of coronavirus deaths, with 4,366 reported on Friday morning. Reported cases reached 57,600 although the real number could be much higher: in the hard-hit regions of Madrid and Catalonia, only seriously ill people and health professionals are being tested as hospitals struggle with a shortage of human and material resources.
Spain purchased 640,000 tests, which arrived on Monday, but four Madrid hospitals that used them found that the tests gave back negative results on patients who were known positives. The Carlos III Health Institute, a public health research center, said that the new rapid tests had a sensitivity of just 30% and could not be used as a reliable tool of detection.
A logistics expert said it is possible that the government, faced with the tremendous current difficulty of securing the tests through the usual distribution channels, may have resorted to an unspecialized intermediary to purchase the material.
Fernando Simón, head of Spain’s health emergency coordination center, said that given the difficulty of importing rapid testing kits, “we are working intensely with Spanish biotechnology companies so we can produce them in Spain within a short space of time.”
The leader of Spain’s main opposition party, Pablo Casado of the Popular Party (PP), said on Twitter that Prime Minister Pedro Sánchez “must explain why the government did not validate the tests he bought that do not work, and whether these were bought from an unlicensed company, as China says. If so, we are dealing with a lack of responsibility that must have consequences.”
Sánchez debe explicar por qué el Gobierno no ha validado los test que ha comprado y que no funcionan, y si se han adquirido a una empresa sin licencia, como dice China. Si es cierto, estamos ante una auténtica irresponsabilidad que debe tener consecuencias.https://t.co/dsdICmY07o— Pablo Casado Blanco (@pablocasado_) March 26, 2020
For now, hospitals will continue to use the polymerase chain reaction (PCR) system, which is very reliable but takes around four hours and requires highly specialized equipment and personnel.
The Health Ministry said that it did not purchase the material directly from China, but through a Spanish distributor who was not named. Earlier, the Chinese embassy in Spain had issued a statement on Twitter saying that Shengzhen Bioeasy Biotechnology does not have a license to sell its products and that it was not on the “list of classified suppliers” that China showed to Spain. The embassy also said that its donations of healthcare equipment to Spain did not include products from this company.
The Spanish Health Ministry said that it conducted checks on the supplier’s reliability and produced a letter from Bioeasy asserting that the company meets all the requirements for export to Europe. The company said in the letter that it is important to respect the kits’ protocols and that it will resend new material “to ensure sensitivity and specificity and help Spain fight Covid-19.”
On Sunday, health authorities announced the purchase of “640,000 rapid tests from China on top of another six million imported from European countries.” The ministry also said that day in a statement that “the first 8,000 tests have been distributed.” That figure was in fact 9,000, according to later statements by Fernando Simón, who said the tests had been distributed in the Madrid region.
Hospitals tried out the tests and the results were included in a document drafted by the Spanish Society of Infectious Diseases and Clinical Microbiology (Seimc), which recommended not using the Chinese tests.
After insisting that the product met EU requirements, Fernando Simón did not conceal his disappointment at the bad news about the rapid tests, which had represented “a significant hope” in the race to conduct widespread coronavirus tests and lighten the load of hospital microbiology labs, which are currently analyzing between 15,000 and 20,000 samples a day using the PCR method. This diagnostic test, which identifies the genetic code of the coronavirus, is more reliable, but can take up to six hours to process.
English version by Susana Urra.