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BRAZILIA – President Jair Bolsonaro said this Monday on a social network that the federal government sent “all the material” for the Covid-19 tests to the states and municipalities, which, according to him, should explain whether these tests win sooner. to be used.
Bolsonaro made the statement when asked by a follower about news that stored and unused tests are about to expire.
The case was revealed by the newspaper “O Estado de S. Paulo”. According to the report, 6.86 million RT-PCR tests stored in São Paulo may expire until January 2021. The stock, the newspaper says, is kept by the Ministry of Health, not the states and municipalities.
“All the material was sent to states and municipalities. If any state / municipality did not use it, they must give their reasons, “said Bolsonaro when answering the follower’s question.
In a note released on Sunday, the Ministry of Health confirmed the existence of tests with an expiration date close to expiration, but did not report the number of kits and did not confirm the number disclosed by “O Estado de S. Paulo” (read the full text then). of the note).
The ministry also reported that: so far no tests have expired; the portfolio awaits studies on the feasibility of extending the validity of the tests acquired; and that the tests are distributed according to the demand of the states.
The National Council of Health Secretaries (Conass) has stated that it has warned the federal government on several occasions about the lack of materials to process PCR test samples.
Testicles
The RT-PCR test is considered the most accurate for the diagnosis of Covid-19. The analysis is based on samples from the nose and throat region and indicates the active virus, that is, the infection still ongoing.
The total of RT-PCR tests performed in Brazil fell in October for the second consecutive month, according to data from the Health Ministry collected and published by G1 last week. So far, just over 5 million of these exams have been performed on the public network.
In a note, the Health Ministry said it expects to receive “extended stability” studies for stored tests this week to verify the feasibility of extending the expiration date.
The ministry also claimed that the kits “are distributed according to the demands of the states.”
See the full notes published by the Ministry of Health and Conass this Sunday:
Ministry of Health
The Health Ministry reports that, as with other test batches used in other countries, extended stability studies for the tests that the pasta has in stock should arrive in Brazil this week.
The company Seegene, provider of the tests to the MS, is already in contact with the National Sanitary Surveillance Agency (Anvisa) to send the studies, as soon as the manufacturer makes them available.
These studies will be analyzed by Anvisa, which is the agency that grants the registration of product use.
Once this technical opinion has been granted, the Ministry of Health will prepare an informative note on the extension of the validity and safety of the use of the tests.
The Ministry of Health also clarifies that given the novelty and unpredictability of the disease in Brazil and in the world, it spared no effort to guarantee COVID-19 diagnostic tests to its population. The portfolio invested in the acquisition of tests and in the structuring of the public laboratory network in Brazil, as well as the implementation of 4 high-test platforms to provide laboratory support to states and municipalities when the production capacity of state laboratories will reach its limit.
It should be noted that the RT-qPCR tests are distributed according to the demands of the states and that the Ministry remains at the disposal of the entities to support the actions of follow-up, diagnosis, treatment and follow-up of the cases, in addition to encouraging actions of prevention. and early assistance in the SUS health services.
The folder has been guaranteeing the availability of RT-qPCR tests for the entire country, allowing the user of the Unified Health System (SUS) to go to the health service and have their test guaranteed, when prescribed by the health professional.
Brazil has examined more than 10,491,142 people, of which 5,043,469 are RT-qPCR tests, out of the 9,317,356 million RT-qPCR tests distributed to State Public Laboratories.
It is also important to clarify that RT-qPCR is not the only way to diagnose the disease. Clinical analysis and early treatment are the strategies that most contribute to preventing the evolution and possible complications derived from Covid-19, being complementary to diagnostic tests.
The folder indicates that no RT-qPCR tests have lost their validity and are ready to be used as required by the states and municipalities, in line with the SUS management, which is tripartite.
Finally, it is important to highlight that the press plays an important role in informing the population about the health facilities and services available throughout the country. And reinforce the importance of looking for a health unit as soon as the first symptom of the disease appears.
National Council of Secretaries of Health (Conass)
Conass alerted the Ministry of Health to the problems of lack of materials for collection and supplies to amplify samples for PCR examination on several occasions during the pandemic, which affected the number of tests carried out. The Council had no information on the volume of evidence of the Ministry’s stocks.
To perform the PCR test, you must have collection material (such as tubes and swabs, types of rods that are used to collect nasal discharge samples), supplies for the extraction of genetic material and, finally, supplies for amplification. They are interconnected and interdependent stages. Amplification inputs can only be used in the second phase of the test, after the extraction of genetic material has been completed.
Tickets for the second part of the test, amplification, were available. But they cannot be used without extraction. For the past few months, Conass has warned of the problem. We spent a good part of the pandemic with difficulty in acquiring collection supplies. The transfer of this material to the States only occurred in August. The supplies for the extraction of viral genetic material and equipment from this stage, in turn, were only transferred from September. In the case of teams, only 10 Lacens were considered.
The barriers are not yet resolved. The contract that allowed the supply of supplies and equipment necessary to automate and streamline the first phase of sample processing was canceled by the Ministry of Health. The ministry is committed to maintaining the supply for a period of 3 months, counted from the cancellation. . However, it is essential that a new contract is concluded and the distribution of supplies resumed in a timely manner. We are concerned about this availability and we are monitoring the situation.
