Anvisa Authorizes the immediate and emergency use of 24,000 units of Monkeypox diagnostic reagents, comprising two molecular kits produced by Bio-Manguinhos/Fiocruz.
Currently Brazil has eight reference laboratories for the diagnosis of Monkeypox, by molecular biology, which have shown limited capacity to meet the growing demand for testing requests.
By requesting the emergency use of the kits, the Ministry of Health intends to decentralize the diagnosis of Monkeypox to the Central Public Health Laboratory Network (Lacen) and provide a more timely diagnosis, reducing the time it takes for the results to be released to the patient.
The authorization was granted after a joint request from the Health Surveillance Secretariat of the Ministry of Health (SVS/MS) and the Bio-Manguinhos/Fiocruz Institute for exceptional authorization to use the aforementioned molecular kits, which are not registered with Anvisa.
About Emergency Authorization: Legislation
There is no commercial diagnostic test in Brazil with Anvisa approved registration. The protocols that have been used in the country for Monkeypox diagnosis have been based on proprietary methodologies developed by clinical laboratories (public or private), called in house methodologies regulated by Anvisa Resolution RDC 302/2005.
About the registration requests Anvisa remains alert and vigilant as to the regulatory and sanitary measures necessary to deal with the health emergency.
However, laboratory testing for cases under investigation is essential for the diagnosis and surveillance of this emerging infection and for access to drugs and vaccines to combat the disease.
Read more: Emegential Confrontation
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