Anvisa receives new requests for registration of monkeypox diagnoses

The National Health Surveillance Agency (Anvisa) received five requests for registration of products for the diagnosis of smallpox in monkeys. In a note released this Thursday (11), the agency said that all processes had already started the analysis.

The first two products were Viasure Monkeypox Virus Real Time PCR Detection Kit, made in Spain by CerTest Biotec, and Monkeypox Virus Nucleic Acid Detection Kit, made in China by Shanghai BioGerm Medical Technology.

According to Anvisa, the two tests are tests that allow the molecular diagnosis of the virus. The kits were evaluated by the technical staff and are awaiting the completion of information from the companies to continue the analysis.

The third product, called Standard M10 MPX/OPX, had its registration application submitted on August 8th. Molecular diagnostics is manufactured by the Brazilian company Eco Diagnóstica, with part of the production outside the country. The technical analysis of the documentation is in progress, according to Anvisa.

The most recent orders, received by Anvisa on Wednesday (10), are: Monkeypox Virus Antigen Rapid Test, which is the first order related to a rapid test for antigen detection, manufactured by the Chinese company Shanghai BioGerm Medical Technology, and the product Molecular Monkeypox Kit (MPXV) Bio-Manguinhos, manufactured in Brazil by the Institute of Technology in Immunobiologicals, Oswaldo Cruz Foundation (Fiocruz).

Monkeypox signs and symptoms

To date, Brazil has recorded 2,458 confirmed cases of monkey pox according to the Ministry of Health.

Cases were registered in the states of São Paulo (1,748), Rio de Janeiro (278), Minas Gerais (102), Federal District (92), Paraná (52), Goiás (53), Bahia (25), Ceará (9 ), Rio Grande do Norte (8), Espírito Santo (7), Pernambuco (13), Tocantins (1), Acre (1), Amazonas (5), Pará (1), Paraíba (1), Piauí (1) , Rio Grande do Sul (29), Mato Grosso (2), Mato Grosso do Sul (8), and Santa Catarina (22).

The clinical manifestations of monkeypox usually include skin lesions in the form of blisters or sores that can appear on different parts of the body, such as the face, hands, feet, eyes, mouth or genitals.

The incubation period is usually 6 to 13 days, but can range from 5 to 21 days. In the most common documented form of the disease, symptoms may appear from the seventh day onwards with a sudden and intense fever.

Signs such as headache, nausea, exhaustion, tiredness and especially the appearance of swollen glands are common, which can happen both in the neck and in the axillary region as well as in the genital part.

The manifestation on the skin occurs between one and three days after the initial symptoms. The signs go through different stages: macula (small spots), papule (small pimple-like sores), vesicle (small blisters), pustule (bubble with the presence of pus) and crust (which are the healing shells).

Source: CNN Brasil

You may also like