Self-test with Anvisa registration will cost up to R$ 70

Companies that had self-tests approved by Anvisa (National Health Surveillance Agency) predict that the product will hit the market by March 7 at a price between R$39 and R$70 for the final consumer.

Anvisa authorized the sale of self-tests in Brazil on January 28. Each company needs to apply for registration to market the product.

The company Eco Diagnóstica had two self-tests approved, one using a nasal swab and the other using a saliva sample.

The company’s forecast, which will manufacture the product in Corinto (MG), is that the self-tests will be available in pharmacies until March 7th. The value must be between R$ 39 and R$ 69.

The product will be sold in three ways: individual and also a box containing three and five tests.

The company is the only one that has the product approved to be performed with saliva collection. She does not need to use the swab (swab), but the kit has this item to transfer the right amount of saliva from the cup to the extraction tube.

The company’s other registered product is the COVID Ag Detect Autotest, with a non-deep nasal swab sample.

The co-owner of the Kovalent company, João Paulo Alves Janoni, said that the self-test should arrive on authorized networks from March 7th to 11th. The factory, located in São Gonçalo (RJ), has the capacity to produce 150,000 tests per week.

He said that he still does not have a fixed value for the product because it depends on the price of inputs that arrive from other countries, but he believes that it can be in the range of R$ 55 to R$ 70 for the final consumer.

The product offered by him is the ​SGTi-flex COVID-19 Ag – SELF-TEST, designed for non-deep nasal swab sample use.

“We registered with Anvisa packages containing 1, 2 and 5 self-tests, but in the first cycle will offer the market the box with only 1 product”, he highlighted.

The company CPMH (Commerce and Industry of Hospital and Dental Medical Products), which had its first self-test approved on January 17, did not provide information on values.

The executive president of CBDL (Brazilian Chamber of Laboratory Diagnosis), Carlos Eduardo Gouvêa, said that the companies producing and importing self-tests are responsible for the price.

He evaluated that only the industry installed in Brazil has the capacity to produce up to 10 million Covid self-tests per month. He expects everyone to strive for the product to be affordable and competitive.

He also highlighted that the country is in a period in which there are still many demands for testing and this should expand.

“Even without the street events, people will travel, gather during the Carnival period, and there is a chance of increasing contamination. The moment is still opportune and it is another tool to combat Covid”, highlighted Gouvêa.

As in other countries, in his view, federal and state governments should adopt self-testing as another testing tool for people. Despite being more affordable than others, it should not reach everyone.

The Ministry of Health has already signaled that it does not intend to buy self-tests to distribute to the population.

According to Anvisa, the product can be purchased in pharmacies, drugstores and health establishments that are licensed by the health surveillance as a trade in medical items. These establishments will also be able to sell online.

In total, 72 registration requests were made to the regulatory agency, of which four were approved.

In addition to these, five have their analysis completed and are awaiting publication in the Official Gazette of the Union and 13 were disapproved.

There are also 28 that were distributed to the responsible area and are awaiting analysis, three are in the process of analysis and 19 are in demand, that is, the regulatory agency requested more data from the company.

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 of the PNE (National Testing Expansion Plan) of the Ministry of Health.

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.