Anvisa (National Health Surveillance Agency) approved the second self-test for Covid-19 this Wednesday (23). The registered product is the Autotest COVID Ag Detect manufactured by the company Eco Diagnóstica Ltda.
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.
The first self-test passed on January 17th. The availability of the product on the market depends on the company holding the registration.
The self-test approved this Wednesday was developed for the use of a sample obtained by a non-deep nasal swab (swab) and which provides the result after 15 minutes. The product will be manufactured in Brazil.
According to the evaluation, the product met the technical criteria defined by the regulatory agency and also had its performance evaluated and approved by the National Institute for Quality Control in Health, as established in the PNE (National Testing Expansion Plan) of the Ministry of Health.
“To analyze the registration request, Anvisa evaluates a series of technical requirements, among which are usability and risk management. These two criteria are central to a self-test and serve to adapt the product to use by lay people, ensuring greater security,” he said in a statement.
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.
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.
As established in a technical note from the Ministry of Health, the self-test will become a new screening tool for the PNE.
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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