Two new Covid-19 self-tests were approved by the National Health Surveillance Agency (Anvisa) this Wednesday (2). Brazil now has six self-tests authorized in the country.
One of them is the “Autotest COVID-19 Ag nasal swab (swab)”, registered by the company Biosul Produtos Diagnósticos Ltda. and manufactured by the Chinese company Hangzhou Alltest Biotech Co., Ltd.
The product will be sold with a test per package, according to Anvisa.
Another approved by the agency is the “SGTi-flex Covid-19 Ag – Self Test”, from Kovalent do Brasil Ltda. This is the second registered by Kovalent, but unlike the previous one, which is manufactured by the company itself, this one is made by Sugentech Inc, from South Korea.
According to Anvisa, the test will be sold in packages with one, two or five tests.
Anvisa reported that it evaluated criteria in relation to safety, performance and compliance with the legal requirements required for self-tests before approval.
In addition, the regulatory agency says it has evaluated the usability of the product, which includes guidelines for use and instructions in plain language — so that anyone can use it correctly.
In addition to the two new ones approved, there are other self-tests authorized in the country. So far they are:
- “Novel Coronavirus (Covid-19) Autotest Antigen”, by the company CPMH Comércio e Indústria de Produtos Médico-Hospitalares e Odontológicas Ltda.;
- “Autotest COVID Ag Detect”, registered and manufactured by the company Eco Diagnóstica Ltda.;
- “Autotest Covid Ag Oral Detect”, registered and manufactured by the company Eco Diagnóstica Ltda.;
- “SGTI-flex Covid-19 Autotest”, registered and manufactured by Kovalente do Brasil Ltda.;
How self-tests work
The self-test is a product that allows the person to perform all the testing steps, from sample collection to result interpretation, without the need for professional assistance. For this, the instructions for use must be followed carefully.
According to Anvisa, the self-test does not define a diagnosis, which must be performed by a health professional. The exam result should be used as a guide only.
Where to buy self tests
Citizens who show symptoms will be able to buy self-tests for Covid-19 antigen research in pharmacies and drugstores that are regularized with the health surveillance for the sale of this type of product.
The test kits will also be marketed by health establishments that are licensed with Anvisa for retail (direct to consumer) medical items. For example, establishments that sell medical devices, such as dressings, compression stockings, orthosis, among others.
Anvisa informs that the online sale is only allowed when carried out directly by the establishments mentioned above. It is not allowed to sell self-tests on e-commerce sites, such as Mercado Livre, Amazon, Americanas, among others.
When can the self-test be done?
Anvisa recommends using the self-test between the 1st and 7th day of the onset of symptoms such as fever, cough, sore throat, runny nose, headaches and body aches. In the face of contact with someone who tested positive and in the absence of symptoms, one should wait five before using the self-test.
What to do with a positive result
The agency’s recommendations, if the result is positive, involve the use of a mask and immediate isolation. Self-tests are used for screening, as a primary approach, and there is the possibility of erroneous results, called false positives.
In this sense, Anvisa recommends medical advice. It is necessary for the patient to seek care at a health service to confirm the diagnosis and thus receive follow-up.
Source: CNN Brasil