Through its Institute of Technology in Immunobiologicals (Bio-Manguinhos), Fiocruz was granted by the Brazilian Health Regulatory Agency, last Tuesday (20 September) the definitive registration for the OPXV/MPXV/VZV/RP Multiplex Molecular Kit for the diagnosis of monkeypox and other diseases with similar symptoms, in a differential manner. The Institute, therefore, becomes the holder of the first registration of a diagnostic product for the disease entirely manufactured in Brazil.
The kit will be used for the diagnosis of monkeypox (the virus in the photo) and other diseases with similar symptoms (image: CDC)
The kit, developed according to recommendations of the World Health Organization (WHO) regarding monkeypox diagnosis, is based on real-time PCR technology with multiplex assays and makes it possible to identify the DNA of the virus by collecting material from the skin rash (pustules) of the individual suspected to have been infected by a virus of the Orthopoxvirus genus, belonging to the Poxviridae family. The kit, therefore, allows for the detection and differential clinical diagnosis of the following targets: general orthopox, general monkeypox, and varicella zoster, and also relies on the control of the kit (RNaseP) to increase its diagnostic capacity, important for epidemiological surveillance at the SUS.
To grant the registration, Anvisa analyzes a series of technical requirements, among which are clinical performance and risk management, with the goal of guaranteeing that the product is suitable for the proposed use. According to the evaluation, the product met the technical criteria defined by the regulatory agency.
Bio-Manguinhos/Fiocruz has already been supplying the kit for use in research to the Public Health Central Laboratories (Lacens) and is getting ready to respond to possible demands of the Brazilian Ministry of Health with the kit already registered, taking into account the time required for production and quality control. The Institute always has the capacity to escalate the production of these new kits, without affecting the offer of other products in its portfolio. The distribution and the possibility to offer the kits to the states will be defined according to the strategy to be adopted by the Ministry.
In addition to the OPXV/MPXV/VZV/RP Multiplex Molecular Kit, Bio-Manguinhos/Fiocruz submitted the registration request for the monkeypox Molecular Kit (MPXV), based on the same technology, also intended to use for detection and typing, containing the targets general monkeypox, Western Africa, and Central Africa (Congo). The Institute is still waiting for its approval.