Anvisa approves first registration of test for monkeypox.
The kit is manufactured by Fiocruz and detects genomic regions of three viruses.
Agência Brasil/EBC - The National Health Surveillance Agency (Anvisa) today (20) approved the first registration, in Brazil, of a test for diagnosing monkeypox. Gift Sets A molecular device, manufactured by the Oswaldo Cruz Foundation (Fiocruz), detects genomic regions of the Orthopox, Monkeypox, and Varicella Zoster viruses.
According to Anvisa (Brazilian Health Regulatory Agency), the product is based on Real-Time PCR technology and is indicated for processing clinical samples. To grant registration, the agency analyzed technical requirements that include clinical performance and risk management, which serve to ensure the suitability of the test for its intended use.
"The evaluation of the registration request by Anvisa took 39 days, including 17 days used by the applicant company to meet the technical requirements made by the agency. The evaluation of the tests for monkeypox "It is being prioritized at the agency, as decided by the board of directors," the agency reported.
The publication of the record It appears in Tuesday's edition of Official GazetteAccording to Anvisa, the availability of the product on the market depends on the company holding the registration.
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