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Ready, go, go. After days of questions, he escapes and takes a first fixed point regarding serological tests. Commissioner Domenico Arcuri launched the tender “in a simplified and extremely urgent procedure” for the purchase of kits, reagents and consumables for’150 thousand tests that will be used for sample research on the spread of the coronavirus. The tender, published on the institutional websites of the Ministry of Health and the Extraordinary Commissioner and the Department of Civil Protection, will conclude in a very short time: Bids must be submitted before April 22. and before April 29 the supply contract will be signed. The president of the Sanita Superior Council announced that it was about to begin Franco Locatelli at a press conference on Civil Protection.
To ensure maximum reliability of the tests, explains the Commissioner’s office, “the evaluation of the proposals will be based on a set of essential quality requirements listed promptly in the call, which will be verified in the coherence of the offers with respect to the object of the offer by an examining Commission, within which there will be, among others, two components designated by the Scientific Technical Committee. “The” fundamental objective “is explained, “is to determine the extent of infection in the Italian population, useful for a gradual reduction of measures to contain contagion.” “The sample survey on seroprevalence – says the Minister of Health Roberto Speranza – It will allow us to understand the level of spread of the virus in the country and plan the next steps and return to activity. It is one of the five points of our health strategy. “
The requirements The serological tests that can be presented by the companies that respond to the call for tenders must meet 8 requirements. Among these, the “sinsurability not less than 90%“Y” response speed with the ability to process at least 120 tests per hour. “And other essential features are the kit type, which must be of the type Clio and / or Elisa for the detection of specific IGg (neutralizing antibodies to Sars Cov 2) and related reagents; validation of tests by qualified laboratories or regulatory agencies that operate nationally or internationally; a test specificity of not less than 95%; the adequacy of the evidence to a large-scale application (trusting the analysis to a large audience of accredited laboratories in the area, without the need for additional training); the speed of transport and delivery of the supply, as of May 3, 2020. The last required characteristic is the willingness to supply additional quantities of the indicated products, indicating the relative conditions and time. Fast transport and delivery of the serological kit supply, “from May 3, 2020”. The offers presented by the companies will be evaluated by one tender commission appointed by the extraordinary commissioner and made up of six experts. The score obtained from each individual offer admitted in the evaluation phase will be determined based on an algorithm.
The two methods: There are two reference methods with different but equally reliable characteristics and yields for serological tests that are so important because rknowing the antibodies in the blood They can find out if the infection has occurred and determine if the infection occurred about a month earlier. Thanks to these tests it will be possible to have “an image of the circulation of the virus in the country, but not an immunity license,” said the president of the Istituto Superiore di Sanità (ISS), Silvio Brusaferro.
“If there is a lot of evidence, there are two reference methods to quantify the presence of antibodies: the method based on chemiluminescence and the method Elisa“Said the virologist Francesco Broccolo, from the Bicocca University of Milan and director of the Cerba laboratory in Milan.
Chemiluminescence (ChLia) is based on a chemical reaction that when antibodies, or immunoglobulins (Ig), bind to the antigen, that is, to a substance that the immune system considers foreign, emits light that is detected by a sensor.
The second method is called Elisa (English acronym “Enzyme-Linked Immunosorbent Assay”) and is a colorimetric method. Also in this case, the antigen attaches to a surface and when it binds to the antibody, this becomes recognizable thanks to an enzyme that causes a color change. “Both methods, Broccolo found, are reliable and highly automated – that is, they allow you to do many tests in one day.” The antibodies recognized in the peripheral venous blood with both methods are immunoglobulins G (IgG), which indicate that the infection has occurred for more than a month.
Possible competitors – Today’s news is that Roche It has developed a serological test that it aims to make available by early May; other running companies are Abbott, Beckmann Coulter, DiaSorin, Snibe, Pantec. Different from these quantitative tests are the rapid ones, which consist of a kind of nitrocellulose tablet in which the presence of the antibodies is revealed by the appearance of a color bar: “They are simple and inexpensive tests, but whose sensitivity,” he concluded. the expert – is less than that of the ChLIa and Elisa methods. “
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