Self-tests: ensuring access to testing is most important
Anvisa releases the sale of Covid-19 self-tests, but companies need to request product registration09/02/2022
The National Health Surveillance Agency (Anvisa) decided on January 28 to release the sale of self-tests for the detection of Covid-19 in Brazil. The authorization allows the commercialization of tests in pharmacies and health establishments. The approval takes place after sending information by the Ministry of Health at the request of Anvisa, which on January 19 postponed the discussion. The request by the Ministry of Health had been made on January 13. With the approval, Anvisa will publish a resolution with the requirements for companies interested in selling self-tests in pharmacies to register the products upon request.
The president of the Brazilian Society of Tropical Medicine (SBMT), Dr. Julio Croda, emphasizes the importance of self-tests as a public health strategy and potentially useful tool in epidemics in which mass testing is wanted to monitor the epidemiological situation. This allows to direct efforts to contain, prevent, and interrupt the transmission chain in the Country. Available in the United States, Canada and the United Kingdom, self-tests, sold in pharmacies or distributed by the public health system, have been made available to the population. Countries such as England, the United States and France are already using this testing model on a large scale.
Dr. Croda assures that the self-tests, once approved by Anvisa, are completely reliable. So that there is no doubt, another measure suggested by the infectologist is to require additional validations, such as the National Institute for Quality Control in Health, an important regulatory body linked to the Oswaldo Cruz Foundation (Fiocruz). Also, according to the researcher, there is a whole apparatus available to ensure high quality for self-tests, which have a quality quite similar to the antigen test, used in Basic Health Units (UBAs) or pharmacies. “Failures even occur in the antigen test performed at health centers,” he observes, explaining that the self-test result being positive does not require confirmation by another methodology, but if the person has flu-like symptoms and the result is negative, it is advisable to do try an RT-PCR test. This is the same recommendation used for the antigen test.
According to Anvisa, the Ministry of Health will include guidelines on products in the National Testing Expansion Plan for Covid-19 (PNE Teste). The president of the SBMT is categorical in noting the importance of conditioning public health policies, such as distribution and registration as a complementary measure for screening and isolation of infected people. “Self-tests should serve as a public health tool, containment of the spread of the virus, and not just as a diagnostic tool. The offer will allow more agility in identifying cases and adopting measures, especially isolation to contain the virus. In addition, they can avoid overloads on the health system, which are far beyond their capacity to provide care,” emphasizes Dr. Croda. The use of self-tests is one of many risk-reducing measures, such as vaccination, mask use and social distancing. “Access to diagnosis guarantees greater adherence to isolation,” he emphasizes.
Approval for the use and commercialization of self-tests is valid only for antigen tests, performed from the nasal or nasopharyngeal swab, or the saliva test, in search of signs of antibodies generated after infection, and does not apply to the RT- PCR, which detects the presence of the viruss genetic material. One of the requirements for the approval of each product was that the self-tests provide information, in clear and precise language, guiding the lay public on how to properly collect biological material and perform the exam. Dr. Croda reinforces the importance of disseminating guidelines on how to collect the biological material, swab, as well as how the person should behave after the procedure. “It is essential that the public has a mechanism so that they can report the results to the health authorities. A simple application made available by the Ministry of Health, for example, or a website with QR Code reading, which brings information regarding the brand and the test batch is essential. In this way, it would be up to the user to complete with the result,” suggests Dr. Croda. The Ministry of Health already has expertise in participatory surveillance, the “Guardians of Health” application, used in the World Cup.
In addition, data transparency is required. Asked whether self-tests can somehow compromise statistical data, the construction of an epidemiological picture or the evolution of genomic surveillance in Brazil, Dr. Croda assures that they cannot. “By observing the epidemic curve, the inter-epidemic periods, we can be aware of an abnormal report made by users. Through this participatory surveillance, we can even detect the increase in the number of cases precisely because of the use of the self-test. For this, we need representative data by region, city, so that we can monitor the epidemiological pattern,” he adds. Currently, Brazil is under a data blackout, mainly on the antigen test, because many municipalities only notify the cases, but do not report the results.
The National Health Council (CNS) published, on January 28, a recommendation for the Ministry of Health to massively distribute self-tests. However, Minister Marcelo Queiroga said that the material will not be delivered free of charge but made available in pharmacies for the public interested in acquiring. For the president of the SBMT, it is essential that the Unified Health System (SUS) incorporate the acquisition and distribution of self-tests to states and municipalities, ensuring that they are made available free of charge to the population and only to symptomatic patients in order to avoid elitizing the diagnosis, since if it is sold, only people with purchasing power will have access. “In understanding the character of exceptionality, the most important thing would be to guarantee universal access. We are confident that the Federal Government can intervene in the purchase and distribution free of cost of self-tests, as is done in all developed countries in Europe and the United States. It is a great stimulus for the population to test and report the results, he says.
Unfortunately, the Ministry of Health does not yet have plans for distribution through the SUS. The Brazilian Chamber of Laboratory Diagnosis (CBDL) suggested in January that self-tests be sold at a lower price than those from pharmacies and laboratories, around R$40 to R$70 [approximately US$8 to US$15]. It is worth remembering that the decision has no immediate effect, as each company interested in marketing its version of the product needs to apply for registration with Anvisa, which will analyze each request. The Agency informed that it expects to have the first products approved this February.