{"id":380,"date":"2025-05-04T22:32:41","date_gmt":"2025-05-04T22:32:41","guid":{"rendered":"https:\/\/www.weregister.com.br\/?p=380"},"modified":"2025-05-12T23:38:02","modified_gmt":"2025-05-12T23:38:02","slug":"anvisa-revises-sanitary-classification-rule-for-ultra-sensitive-pcr","status":"publish","type":"post","link":"https:\/\/www.weregister.com.br\/pt\/2025\/05\/04\/anvisa-revises-sanitary-classification-rule-for-ultra-sensitive-pcr\/","title":{"rendered":"ANVISA revisa regra de enquadramento sanit\u00e1rio para PCR ultrassens\u00edvel"},"content":{"rendered":"<p>A PCR ultrassens\u00edvel \u00e9 utilizada no monitoramento e triagem do risco de eventos cardiovasculares, possibilitando o progn\u00f3stico e monitoramento preventivo de inflama\u00e7\u00f5es e infec\u00e7\u00f5es nas paredes dos vasos sangu\u00edneos, antes da manifesta\u00e7\u00e3o de sintomas cl\u00ednicos, j\u00e1 identificando altera\u00e7\u00f5es inflamat\u00f3rias em pacientes aparentemente saud\u00e1veis.<\/p>\n<p>Trata-se de uma prote\u00edna de fase aguda positiva, marcador de inflama\u00e7\u00e3o sist\u00eamica, que aumenta em resposta a diversos tipos de les\u00e3o, em particular a infec\u00e7\u00f5es bacterianas.<\/p>\n<p>Considerando as m\u00faltiplas aplica\u00e7\u00f5es e contextos de uso, houve a diferencia\u00e7\u00e3o da classifica\u00e7\u00e3o de risco dos par\u00e2metros Prote\u00edna C Reativa - PCR (classe II) e PCR ultrassens\u00edvel (classe III), tendo por base a Regra 3 (i) vigente na RDC n\u00ba 830\/2023. O enquadramento da PCR ultrassens\u00edvel na classe de risco II reflete seu papel como um exame complementar na avalia\u00e7\u00e3o de risco, sem implicar em decis\u00f5es de tratamento que coloquem a vida do paciente em risco iminente.<\/p>\n<p><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/setorregulado\/regularizacao\/produtos-para-saude\/notas-tecnicas\/nota-tecnica-no-17-2025-sei-gevit-ggtps-dire3-anvisa#:~:text=Trata%2Dse%20de%20uma%20prote%C3%ADna,cl%C3%ADnicas%20que%20constituem%20est%C3%ADmulos%20inflamat%C3%B3rios.\" target=\"_blank\" rel=\"noopener\">Nota T\u00e9cnica \/ 17\/2025\/SEI\/GEVIT\/GGTPS\/DIRE3\/ANVISA<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Ultra-sensitive CRP is used to monitor and screen the risk of cardiovascular events, enabling prognosis and preventive monitoring of inflammation and infections in the blood vessels walls, before the manifestation of clinical symptoms, already identifying inflammatory changes in apparently healthy patients. It is a positive acute phase protein, a marker of systemic inflammation, which increases in response to various types &#8230; <\/p>\n<div><a href=\"https:\/\/www.weregister.com.br\/pt\/2025\/05\/04\/anvisa-revises-sanitary-classification-rule-for-ultra-sensitive-pcr\/\" class=\"more-link\">Read More<\/a><\/div>","protected":false},"author":1,"featured_media":388,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-380","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/posts\/380","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/comments?post=380"}],"version-history":[{"count":5,"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/posts\/380\/revisions"}],"predecessor-version":[{"id":391,"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/posts\/380\/revisions\/391"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/media\/388"}],"wp:attachment":[{"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/media?parent=380"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/categories?post=380"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.weregister.com.br\/pt\/wp-json\/wp\/v2\/tags?post=380"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}