The Brazilian Health Regulatory Agency (Anvisa) has granted, last Monday (10/4), the registry of a new test for Covid-19 diagnosis, developed by CT-Vacinas, a center composed of researchers from Fiocruz Minas and the Federal University of Minas Gerais (UFMG). Called Elisa Covid-19 IgG Kit, the test is based on the Elisa method, an acronym for enzyme-linked

immunosorbent assay, known for offering lower risks for false-negative results due to its high sensitivity. Such characteristic is attributed to the kit developed by the CT-Vacinas team, due to its capacity to detect low levels of antibodies.

Another important attribute of the Elisa Covid-19 IgG Kit is the capacity to detect the coronavirus variants, more present both in Brazil and in the rest of the world. “The protein used in this test has a low mutation rate that associates with the variants, which makes the exam capable of identifying the virus presence in any of these variants”, explains the researcher Ricardo Gazzinelli, the study’s coordinator.

The test was 100% developed in Brazil, contributing to the guarantee of more autonomy for the country, regarding the testing. According to Gazzinelli, with the approval by Anvisa, the kit can already be distributed to the campaign laboratories.

The research has received support from RedeVírus, linked to the Ministry of Science, Technology and Innovation (MCTI), which allocated around R$10 million. The Elisa Covid-19 IgG Kit has also received funding by the Minas Gerais Research Funding Foundation (Fapemig) and the National Institute of Science and Technology for Vaccines (INCT-V). The escalation of processes and all production will be carried out by Bio-Manguinhos, a Fiocruz unit located in Rio de Janeiro.

Several researchers participated in the study, including Ana Paula Fernandes, Flávio Fonseca, Santuza Teixeira, Flávia Bagno, and Natália Salazar.

Source: Fiocruz News Agency (AFN)