The Oswaldo Cruz Foundation (Fiocruz), through the Institute of Technology on Immunobiologicals (Bio-Manguinhos), received from the National Health Surveillance Agency (Anvisa) the definitive registration of two IVDs for monkeypox: Molecular Multiplex OPV/ MPXV/VZV/RP and Molecular Monkeypox (MPXV). With these, the Institute becomes the holder of the first diagnostic products for the disease, entirely developed and produced in Brazil.

The Molecular Monkeypox Kit (MPXV) detects the genomic regions Monkeypox general (MPXV) and West Africa (WA), with confirmed circulation in Brazil, and identifies, in the same human sample, the two genetically distinct strains of the virus. This kit is indicated for the qualitative diagnosis, determining the presence or absence of the Monkeypox virus and for viral typing. And the Molecular Multiplex OPV/MPXV/VZV/RP Kit allows the detection and differential clinical diagnosis of the general Orthopox, General Monkeypox, and Varicella Zoster (VZV) targets.

Both tests are based on real-time PCR technology with multiplex assays and enables the identification of the DNA of the causative virus through the collection of material taken from the skin rashes (pustules) present in the suspected individual infection of the Orthopoxvirus genus belonging to the Poxviridae family. In addition to being developed based on the recommendations of the World Health Organization (WHO), related to the diagnosis of monkeypox and rely on the control of the kit (RNaseP), providing greater capacity for diagnostic clarification, which is important for epidemiological surveillance in the Brazilian Public Health System.

In order to grant the registration, Anvisa analyzes a series of technical requirements, including clinical performance and risk management, which serves to ensure the suitability of the product for the proposed use. According to the evaluation, the product met the technical criteria defined by the Agency.

Journalist and translation: Juliana Xavier

Image: Bernardo Portella.