Two new PCR tests for monkeypox submitted to Brazil watchdog
Brazil’s research foundation Fiocruz has filed for the registration of two molecular diagnostic kits for the monkeypox virus with the country’s national drug authority Anvisa.
The virus is considered an international public health emergency by the World Health Organization, and the country’s national watchdog has thus far received five such requests.
One of the kits produced by Fiocruz, called Bio-Manguinhos Monkeypox Molecular Kit, can identify the two strains of the virus that circulate endemically in the African continent. Only one of them, the West African strain, is responsible for the outbreak in other continents.
This is a PCR-type test that can detect the DNA of these two virus types in samples taken from the rash on individuals with suspected infections.
The second kit submitted is designed for differential diagnosis, in which related viruses are ruled out.
The tests may enable the adoption of two protocols: under protocol one, the first test performs viral detection and typing. In the case of a negative result, protocol two helps clarify the diagnosis with the differential test. This is regarded as key for epidemiological surveillance in Brazil’s public healthcare network SUS.
In addition to having developed the tests and requested their registration, Fiocruz has produced enough to run 12 thousand tests in suspected cases, and says it can scale up the production of these kits without jeopardizing the supply of other products from its portfolio.
Fiocruz head Nísia Trindade Lima said that a more effective supply chain and a solid production arrangement at the local level can help build autonomy in Brazil when it comes to the manufacture of supplies crucial in tackling public health challenges.
