The National Health Surveillance Agency (Anvisa) approved the registration of the second self-test for Covid-19 in Brazil, according to a disclosure made this Wednesday (23). The manufacturer is Eco Diagnostica Ltda., which will carry out the COVID Ag Detect Autotest in Brazil.
“The product met the technical criteria defined by the Agency and also had its performance evaluated and approved by the National Institute for Quality Control in Health (INCQS), as established in the National Testing Expansion Plan (PNE) of the Ministry of Health,” he said. to Anvisa.
The first self-test for Covid-19 — which allows the identification of the virus in nasal secretions collected with a cotton swab and subjected to chemical processes — was approved in Brazil on February 17.
In general, the patient who has the kit performs the collection through the secretion of the nose or mouth with a cotton swab. Subsequently, the rod is introduced into a chemical process and placed for testing. The result is available in less than half an hour, overall, indicating both a positive and negative result for the presence of the virus.
To meet the requirements listed by Anvisa as necessary for approval, the second self-test took 22 days of analysis and compliance with the listed requirements, in addition to a technical meeting for the presentation of information, the agency said.
Other orders
With the approval, the sale of exams by pharmacies and health establishments licensed to sell medical devices is allowed.
However, commercialization, distribution and use in the country depend on Anvisa authorizing companies that produce the self-tests.
It is possible to follow each order on the Anvisa panel, which has not yet been updated with the recent approval.
Registration requirements
Among the requirements to grant the registration, Anvisa determines that the products must present instructions for use, storage and disposal. The information must have simple language and illustrations, to facilitate handling and interpretation of the result.
Regarding the packaging, Anvisa’s guidelines state that the external label of the product must contain all the components of the kit that are necessary for carrying out the test, in addition to the validity of the device.
In addition, the manufacturer must offer a service channel to the user to guide and forward the demands on the use of the product and how to proceed after obtaining the result.
According to Anvisa, in addition to providing the contact for this service, the company must indicate the Dial Saúde service of the Ministry of Health, in accordance with the recommendations of the National Testing Expansion Plan for Covid-19, the PNE-Teste.
Source: CNN Brasil
