Fiocruz Minas test for covid-19 receives registration from Anvisa

In order to diagnose covid-19 in an effective and cheaper way, numerous Brazilian studies have sought solutions to this challenge. Now, the National Health Surveillance Agency (Anvisa) has authorized the registration of a new serological test to identify antibodies to the SARS-CoV-2 coronavirus, developed by CT-Vaccinas. The group is formed by researchers from Fiocruz Minas — also known as the René Rachou Institute — and from the Federal University of Minas Gerais (UFMG).

The new covid-19 test was dubbed the Elisa covid-19 IgG Kit, because it is based on the Elisa immunoenzymatic method. Overall, this method offers less risk for covid-19 false negatives due to its high sensitivity. In other words, the strategies adopted by the Fiocruz test can detect low levels of antibodies and, therefore, it is considered more accurate.

Fiocruz Minas’ antibody test is registered by Anvisa (Image: Reproduction/Fiocruz Minas)

In a previous interview with Agência Brasil, CT-Vacinas researcher Flávio Fonseca explained: “The test we developed detects the presence of antibodies against the virus. The serum is collected and the result analyzed in the laboratory, using an enzymatic reaction that is expressed in the reader”. At the time, the technology was still validated.

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Another differential is that the test is able to detect the main variants of the coronavirus. “The protein used in this test has a low mutation rate that is associated with the variants, which means that the test can identify the presence of the virus in any of these variants”, explains researcher Ricardo Gazzinelli, coordinator of the study.

Fiocruz’s covid test must be mass produced

The test was 100% developed in Brazil and, when mass produced, should guarantee more autonomy for the country with regard to testing the covid-19. According to Gazzinelli, with the approval of Anvisa, the kit should already be distributed to field laboratories.

According to a statement released by Fiocruz Minas, the scheduling of the processes and the entire production of the tests will be carried out by the Bio-Manguinhos Institute, another Fiocruz unit located in Rio de Janeiro.

To be developed, the project received support from RedeVírus, linked to the Ministry of Science, Technology and Information (MCTI), which allocated around R$ 10 million. In addition, the Elisa Kit also received funding from the Research Support Foundation of Minas Gerais (Fapemig) and the National Institute of Vaccine Science and Technology (INCT-V).

Source: Fiocruz Minas e Brazil Agency

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