Health

Emergency use of monkeypox diagnostic kit allowed in Brazil

The move should help decentralize diagnosis in the country

Pedro Rafael Vilela

Published on 30/08/2022 - 10:30

Brasília

03_A varíola dos macacos é transmitida pelo vírus monkeypox, que pertence ao gênero orthopoxvirus — © Débora F. Barreto-Vieira/IOC/Fiocruz

Brazil’s drug authority Anvisa on Monday (Aug 29) authorized the immediate and emergency use of 24 thousand molecular kits for the laboratory diagnosis of monkeypox. The reagents are produced by the Bio-Manguinhos/Fiocruz Institute and their registration is still in progress at the watchdog.

The authorization was granted after a t request was lodged by the Ministry of Health and the Bio-Manguinhos Institute. The regulator’s directors took into the current epidemiological situation of monkeypox in the country, the limitation facing laboratory response today, the amount of tests withheld, the risk associated with delayed diagnosis, and the need to decentralize testing—among other factors.

Emergency use

As it stands today, Brazil has eight laboratories performing the molecular diagnosis of monkeypox, but they have not been able to meet the demand. The move is expected to enable the Ministry of Health to decentralize the diagnosis of the disease through the Network of Central Public Health Laboratories in the states, reducing the time to disclose results to patients.

To date, no commercial diagnostic test for monkeypox has had its registration approved by Anvisa.