Anvisa (National Health Surveillance Agency) approved this Friday (25) two new self-tests for Covid-19. It is the first time that the regulatory agency has approved a self-test that uses saliva.
The regulatory body authorized the sale of self-tests in Brazil on January 28. Each company needs to apply for registration to market the product. In total, four self-tests have already been approved in the country.
One of the approved self-tests is the Covid Ag Oral Detect Autotest registered in the name of the company Eco Diagnóstica. It is the first product registered in Brazil that uses a saliva sample. It will be manufactured in Brazil.
Collection requires the user to spit saliva into a cup. This collection does not use a swab (swab), but the kit has this item that will only be used to transfer the right amount of saliva from the cup to the extraction tube
the other is the SGTi-flex COVID-19 Ag – AUTOTEST registered in the name of the company Kovalent do Brasil, which will also have national manufacture. The self-test is designed for use with a non-deep nasal swab (swab) sample.
To obtain the registration, the products were evaluated for safety, performance and compliance with legal requirements.
“One of Anvisa’s main points of attention for analyzing self-tests is usability, which includes guidelines for use and instructions in simple language that allow the lay person to make the correct use of the product,” said Anvisa in a note.
The self-test is the product that allows the person to carry out all the stages of testing, from sample collection to interpretation of the result, without the need for professional assistance. To do so, you must carefully follow the information in the instructions for use, which have simple language and illustrative step-by-step figures.
This type of product will allow the expansion of testing of symptomatic and asymptomatic individuals and possible contacts. This will allow early isolation and breaking the chain of transmission.
As established in a technical note from the Ministry of Health, the self-test will become a new screening tool for the PNE (National Testing Expansion Plan).
With this, anyone who receives a positive result should seek a health care unit or telecare so that a health professional can confirm the diagnosis, notify and provide relevant guidelines for surveillance and health care. Thus, the user of the self-test is not obliged to report the result to the Ministry of Health.
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