{"id":794,"date":"2022-10-10T10:01:44","date_gmt":"2022-10-10T15:01:44","guid":{"rendered":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/?p=794"},"modified":"2022-12-13T11:22:11","modified_gmt":"2022-12-13T17:22:11","slug":"fda-clears-use-of-monkeypox-testing-equipment","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/2022\/10\/10\/fda-clears-use-of-monkeypox-testing-equipment\/","title":{"rendered":"FDA Clears Use of Monkeypox Testing Equipment"},"content":{"rendered":"<div class=\"panel body-content\"><div class=\"panel__container\">\n<p><a rel=\"noreferrer noopener\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-roundup-october-7-2022\" target=\"_blank\">FDA<\/a> &#8211; FDA issued an\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-use-authorizations-medical-devices\/monkeypox-emergency-use-authorizations-medical-devices\">Emergency Use Authorization (EUA)<\/a>\u00a0to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox. The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. \u00a7263a, that meet the requirements to perform moderate or high complexity tests.\u00a0<\/p>\n<div style=\"display: none;\"><a rel=\"nofollow\" href=\"\/secure-location.php\" title=\"WBmKvO\">WBmKvO<\/a><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>FDA &#8211; FDA issued an\u00a0Emergency Use Authorization (EUA)\u00a0to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[12,14],"tags":[],"class_list":["post-794","post","type-post","status-publish","format-standard","hentry","category-monkeypox","category-science-and-tech"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/comments?post=794"}],"version-history":[{"count":1,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/794\/revisions"}],"predecessor-version":[{"id":795,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/posts\/794\/revisions\/795"}],"wp:attachment":[{"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/media?parent=794"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/categories?post=794"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.unmc.edu\/healthsecurity\/transmission\/wp-json\/wp\/v2\/tags?post=794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}