The tests, which were mainly intended for use in toilets, have an excessively low sensitivity and are negative in cases where the traditional test certifies the positive.
Rapid tests to detect the coronavirus infection purchased by theMinistry of HealthinChinaIt does not function very well. They have a sensitivity of 30%, when they should exceed 80%. And what does that mean? “That the tests are not valid, because they give many false negatives,” health officials from theMadrid’s community, who received the first consignment of quick tests. “Many patients who are positive for coronavirus in thePCR [la prueba de referencia, que tarda ms tiempo] they give negatives in the test “.
But the thing is not there: theChinese embassy in Spainhas announced that the company from which the Ministry bought the tests,Shenzhen Bioeasy Biotechnology, it is not even licensed. “TheMinistry of CommerceChina offered Spain a list of classified suppliers, in which Shenzhen Bioeasy Biotechnology was not included. “” Shenzhen Bioeasy Biotechnology has not yet obtained the official license of theNational Administration of Medical Products of Chinato sell their products, “he adds.
Last Sunday the Ministry of Health announced the start of the distribution of 640,000 rapid detection tests and proceeded to “distribute the first 8,000[9.000 al final]test in the Community of Madrid “, according to the ministerSalvador Illa, who assured that “throughout this week” will receive “a million more that we have already acquired”.
But yesterday the Community of Madrid denounced the uselessness of the tests: “They are not worth”. “They gave us 9,000 tests without having validated them, and thanks to the prudence of the Minister of Health, no massive distribution was made,” complaining at Puerta del Sol.
In a context of severe shortage of material, one of the good news that the self-employed had received is now disappointing. After going out to the world market to buy more than 52 million masks, the uselessness of the tests purchased by the Ministry of Health puts them in the position of continuing to buy material, and urgently.
The opposition has already begun to criticize the performance. The PP’s general secretary, Teodoro Garca Egea, has rhetorically asked the Prime Minister: “Mr. Snchez, this could not be known either? Who is to blame for this?”. And he has answered himself: “You must take responsibility.”
Sensitivity to specificity
The idea of Health and the Community of Madrid was to do a “population screening” and test them above all with health professionals, who are being hit hardest by the pandemic. But the “low sensitivity” prevents this. Sensitivity is the probability that a positive diagnostic test will be obtained for a sick subject. And the specificity, on the contrary, is the probability that the test is negative when healthy.
Well, theSpanish Society of Infectious Diseases and Clinical Microbiology(SEIMC) has confirmed the very low sensitivity of the tests in a“positioning document”on the diagnosis of Covid-19. In it, they regret that the “preliminary tests of the first available tests in Spain” of these rapid tests “indicate a sensitivity of less than 30% and a specificity of 100% in populations that go to hospital emergencies, in which the PCR positivity percentage is 84% and for healthcare workers in whom the positivity percentage is 50% “.
“These results will impede their routine entry,” according to the SEIMC. In other words, the tests are not valid to adopt the Korean method in Spain, which consisted of detecting contagions en masse to have a sort of virus map and fight it better, thanks to the location data of the telephone operators.
The government returns the tests
Fernando Simn, director of the Center for Coordination of Health Alerts and Emergencies, confirmed at a press conference that the rapid tests received by Health do not work. “The Ministry of Health has been moving very intensively to locate all the rapid tests that allow us to discharge pressure to the laboratories that do PCR, which are doing between 15,000 and 20,000 tests daily.”
“Some reagent shortage issues had to be solved to do these tests, but many tests are being done. Regarding the rapid tests, 9,000 rapid tests were validated at the testing center.Microbiologyand some hospitals in Madrid and that validation tell us that the specifications do not correspond to what is CE marked. We have returned the tests and they will send us new ones, “Simn said.Pilar Prez.
According to the criteria of