{"id":411344,"date":"2020-03-28T08:37:31","date_gmt":"2020-03-28T08:37:31","guid":{"rendered":"https:\/\/clarivate.com\/life-sciences-healthcare\/?p=411344"},"modified":"2025-03-10T08:39:23","modified_gmt":"2025-03-10T08:39:23","slug":"covid-19-testing-fda-guidance-update","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/zh\/blog\/covid-19-testing-fda-guidance-update\/","title":{"rendered":"COVID-19\u6aa2\u6e2c\uff1aFDA\u6307\u5357\u66f4\u65b0"},"content":{"rendered":"\n<p><em>SARS-CoV2<\/em><em>\u7684\u6301\u7e8c\u50b3\u64ad\u5c0e\u81f4\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7279\u6b8a\u50b3\u67d3\u6027\u80ba\u708e\uff08<\/em><em>COVID-19<\/em><em>\uff09\uff0c\u6211\u5011\u6aa2\u8996\u4e86<\/em><em>FDA<\/em><em>\u95dc\u65bc\u9ad4\u5916\u8a3a\u65b7\u6aa2\u6e2c\u548c\u53e3\u7f69\u5728\u91ab\u7642\u74b0\u5883\u4e2d\u4f7f\u7528\u7684\u6307\u5357\uff0c\u91cd\u9ede\u8a0e\u8ad6\u4e86\u7576\u524d\u7684\u6cbb\u7642\u548c\u75ab\u82d7\u8a66\u9a57\u3002<\/em><\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u672c\u6587\u4f5c\u8005\uff1aJaime Polychrones\uff0c\u79d1\u777f\u552f\u5b89 Cortellis Regulatory Intelligence \u91ab\u5b78\u4f5c\u8005<\/strong>\uff08\u82f1\u6587\u539f\u6587\u767c\u4f48\u65e5\u671f\uff1a2020\u5e743\u670811\u65e5\uff09<\/p>\n<p>&nbsp;<\/p>\n<p>\u65b0\u578b\u51a0\u72c0\u75c5\u6bd2\u9996\u6b21\u5728\u4e2d\u570b\u6e56\u5317\u7701\u6b66\u6f22\u5e02\u767c\u73fe\uff0c\u76ee\u524d\u5df2\u5728\u5305\u62ec\u7f8e\u570b\u5728\u5167\u7684\u5168\u740350\u500b\u5730\u5340\u767c\u73fe\uff0c\u6bcf\u5929\u90fd\u6709\u65b0\u589e\u75c5\u4f8b\u516c\u5e03\u3002\u8a72\u75c5\u6bd2\u88ab\u7a31\u70baSARS-CoV2\uff0c\u5c0e\u81f4\u7684\u75be\u75c5\u88ab\u7a31\u70ba\u56b4\u91cd\u7279\u6b8a\u50b3\u67d3\u6027\u80ba\u708e\uff08COVID-19\uff09\u3002FDA\u8868\u793a\uff0c\u8003\u616e\u5230\u9019\u7a2e\u75c5\u6bd2\u80fd\u5920\u5feb\u901f\u50b3\u64ad\uff0c\u5b83\u53ef\u80fd\u6703\u5c0d\u7f8e\u570b\u91ab\u7642\u7cfb\u7d71\u548c\u6574\u500b\u793e\u6703\u9020\u6210\u91cd\u5927\u5f71\u97ff\u3002<\/p>\n<p>\u64da\u4e16\u754c\u885b\u751f\u7d44\u7e54\uff08WHO\uff09\u5831\u544a\uff0c\u7d042%\u7684\u60a3\u8005\u6b7b\u4ea1\u3002\u76ee\u524d\u89e3\u51b3SARS-CoV2\u50b3\u64ad\u7684\u65b9\u6cd5\u5305\u62ec\u958b\u767c<em>\u9ad4\u5916<\/em>\u8a3a\u65b7\u6aa2\u6e2c\u65b9\u6cd5\u3001\u5141\u8a31\u8ca0\u8cac\u611f\u67d3\u60a3\u8005\u6cbb\u7642\u7684\u91ab\u52d9\u4eba\u54e1\u4f7f\u7528\u7279\u5b9a\u53e3\u7f69\u3001\u4ee5\u53ca\u958b\u767cCOVID-19\u7684\u6cbb\u7642\u65b9\u6cd5\u548c\u75ab\u82d7\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u7f8e\u570b\u5c0d\u5feb\u901f\u6aa2\u6e2c\u7684\u9700\u6c42<\/strong><\/p>\n<p>2020\u5e742\u670829\u65e5\uff0cFDA\u5ba3\u5e03\u4e86\u91dd\u5c0d\u7a4d\u6975\u958b\u767c\u51a0\u72c0\u75c5\u6bd2\u8a3a\u65b7\u8a66\u9a57\u7684\u7279\u5b9a\u5be6\u9a57\u5ba4\u7684\u65b0\u653f\u7b56\u3002\u8a72\u653f\u7b56\u4ee5\u7acb\u5373\u767c\u5e03\u7684\u6307\u5357\u5f62\u5f0f\u5448\u73fe\uff0c\u65e8\u5728\u5e6b\u52a9\u7f8e\u570b\u5be6\u73fe\u66f4\u5feb\u7684\u6aa2\u6e2c\u80fd\u529b\u3002FDA\u5f3a\u8abf\uff0c\u5b83\u4e26\u672a\u6539\u8b8a\u7dca\u6025\u4f7f\u7528\u6388\u6b0a\uff08EUA\uff09\u7684\u7c3d\u767c\u6a19\u6e96\uff0c\u9019\u4e00\u884c\u52d5\u9ad4\u73fe\u4e86FDA\u5c0d\u4fdd\u8b77\u516c\u8846\u5065\u5eb7\u548c\u89e3\u6c7a\u95dc\u9375\u5065\u5eb7\u9700\u6c42\u7684\u6c7a\u5fc3\u3002FDA\u6700\u8fd1\u4e00\u6b21\u91dd\u5c0d\u7528\u65bc\u8a3a\u65b7\u548c\u61c9\u5c0d\u7a81\u767c\u516c\u5171\u885b\u751f\u4e8b\u4ef6\u7684\u8a3a\u65b7\u548c\u6cbb\u7642\u7528\u91ab\u7642\u5668\u6750\u767c\u5e03\u7684EUA\u662f2016\u5e74\u91dd\u5c0d\u8332\u5361\uff08Zika\uff09\u75c5\u6bd2\u767c\u5e03\u7684\u3002<\/p>\n<p>\u5feb\u901f\u61c9\u5c0dCOVID-19\u7206\u767c\u7684\u95dc\u9375\u662f\u5feb\u901f\u6aa2\u6e2c\u611f\u67d3\u75c5\u4f8b\u3001\u9452\u5225\u8207\u611f\u67d3\u8005\u63a5\u89f8\u7684\u4eba\u7fa4\u4e26\u9069\u7576\u7ba1\u7406\u81e8\u5e8a\u8b77\u7406\u548c\u611f\u67d3\u3002FDA\u8868\u793a\uff0c\u9700\u8981\u5728\u516c\u5171\u91ab\u7642\u74b0\u5883\u3001\u591a\u7a2e\u985e\u578b\u5be6\u9a57\u5ba4\u548c\u5e8a\u65c1\u9032\u884c\u5ee3\u6cdb\u6aa2\u6e2c\u3002<\/p>\n<p>\u4e00\u4e9b\u6b63\u5728\u958b\u767c\u548c\u4f7f\u7528\u7d93\u9a57\u8b49\u7684COVID-19\u8a3a\u65b7\u65b9\u6cd5\u7684\u5be6\u9a57\u5ba4\u5728FDA\u5b8c\u6210\u5c0d\u5176EUA\u7533\u8acb\u7684\u5be9\u67e5\u4e4b\u524d\u5c31\u5df2\u7d93\u958b\u59cb\u958b\u767c\u548c\u4f7f\u7528\u3002\u9019\u4e9bEUA\u662f\u57fa\u65bc\u5c0d\u7f8e\u570b\u885b\u751f\u8207\u516c\u8846\u670d\u52d9\u90e8\uff08HHS\uff09\u78ba\u5b9a\u767c\u751f\u7a81\u767c\u516c\u5171\u885b\u751f\u4e8b\u4ef6\u6216\u7a81\u767c\u516c\u5171\u885b\u751f\u4e8b\u4ef6\u7684\u53ef\u80fd\u6027\u589e\u52a0\u6642\u300c\u53ef\u5c0d\u67d0\u7a2e\u75be\u75c5\u6216\u75c7\u72c0\u9032\u884c\u6709\u6548\u8a3a\u65b7\u3001\u6cbb\u7642\u6216\u9810\u9632\u7684\u67d0\u4e9b\u91ab\u7642\u7522\u54c1\u300d\u7684\u76f8\u95dc\u79d1\u5b78\u6578\u64da\u7684\u5be9\u67e5\u3002<\/p>\n<p>\u8a72\u51b3\u5b9a\u7531HHS\u79d8\u66f8\u9577\u65bc2020\u5e742\u67084\u65e5\u4f5c\u51fa\uff0c\u4ee5\u6388\u6b0a\u7dca\u6025\u4f7f\u7528<em>\u9ad4\u5916<\/em>\u8a3a\u65b7\uff08IVD\uff09\u65b9\u6cd5\u4f86\u6aa2\u6e2c\u548c\/\u6216\u8a3a\u65b7COVID-19\u7206\u767c\u3002\u5230\u76ee\u524d\u70ba\u6b62\uff0cFDA\u5df2\u7d93\u5411\u7f8e\u570b\u75be\u75c5\u63a7\u5236\u8207\u9810\u9632\u4e2d\u5fc3\uff08CDC\uff09\u548c\u4e00\u4e9b\u516c\u5171\u885b\u751f\u5be6\u9a57\u5ba4\u7c3d\u767c\u4e86EUA\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong>COVID-19<\/strong><strong><em>\u9ad4\u5916<\/em><\/strong><strong>\u8a3a\u65b7\u6aa2\u6e2c\u6307\u5357<\/strong>><\/p>\n<p>2020\u5e742\u670829\u65e5\uff0cFDA\u767c\u5e03\u4e86\u300c\u7acb\u5373\u751f\u6548\u7684\u81e8\u5e8a\u5be6\u9a57\u5ba4\u548c\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u5de5\u4f5c\u4eba\u54e1\u6307\u5357\uff1a\u91dd\u5c0d\u7d93CLIA\u8a8d\u8b49\u53ef\u9032\u884c\u9ad8\u8907\u96dc\u6027\u6aa2\u6e2c\u7684\u5be6\u9a57\u5ba4\u5728\u7a81\u767c\u516c\u5171\u885b\u751f\u4e8b\u4ef6\u671f\u9593\u7372\u5f97COVID-19\u7dca\u6025\u4f7f\u7528\u6388\u6b0a\u524d\u958b\u5c55\u8a3a\u65b7\u6aa2\u6e2c\u7684\u653f\u7b56\uff082020\u5e742\u670829\u65e5\uff09\u300d\uff0c\u7531\u65bc\u5c0d\u6aa2\u6e2c\u7684\u9700\u6c42\u8feb\u5207\uff0c\u8a72\u6307\u5357\u672a\u5fb5\u6c42\u516c\u8846\u610f\u898b\u3002FDA\u73fe\u6b61\u8fce\u901a\u904e\u96fb\u5b50\u65b9\u5f0f\u548c\u90f5\u4ef6\u5c0d\u8a72\u6307\u5357\u63d0\u51fa\u610f\u898b\uff08\u5377\u5b97\u7de8\u865f\uff1aFDA-2020-D-0987\uff09\u3002<\/p>\n<blockquote>\n<p><strong>\u9019\u4e00\u6b0a\u5b9c\u63aa\u65bd\u53ef\u4ee5\u964d\u4f4e\u958b\u767c\u6210\u672c\uff0c\u52a0\u5feb\u6aa2\u6e2c\u4e2d\u5fc3\u7684\u9032\u7a0b\uff0c\u540c\u6642\u6fc0\u52f5\u5176\u4ed6\u79c1\u4eba\u6aa2\u6e2c\u958b\u767c\u3002<\/strong><\/p>\n<\/blockquote>\n<p>&nbsp;<\/p>\n<p>FDA\u8868\u793a\uff0c\u4e0d\u53cd\u5c0d\u5728\u5be6\u9a57\u5ba4\u7533\u8acbEUA\u671f\u9593\u5c07\u9019\u4e9b\u8a66\u9a57\u7528\u65bc\u81e8\u5e8a\u6aa2\u6e2c\u3002\u672c\u653f\u7b56<strong><em>\u50c5<\/em><\/strong>\u9069\u7528\u65bc\u7d93\u8a8d\u8b49\u53ef\u57f7\u884c\u7b26\u5408\u81e8\u5e8a\u5be6\u9a57\u5ba4\u6539\u9032\u4fee\u6b63\u6848\uff08CLIA\uff09\u8981\u6c42 [42 CFR 493] \u7684\u9ad8\u8907\u96dc\u6027\u6aa2\u6e2c\u7684\u5be6\u9a57\u5ba4\u3002\u9019\u4e00\u6b0a\u5b9c\u63aa\u65bd\u53ef\u4ee5\u964d\u4f4e\u958b\u767c\u6210\u672c\uff0c\u52a0\u5feb\u6aa2\u6e2c\u4e2d\u5fc3\u7684\u9032\u7a0b\uff0c\u540c\u6642\u6fc0\u52f5\u5176\u4ed6\u79c1\u4eba\u6aa2\u6e2c\u958b\u767c\u3002<\/p>\n<p>\u5728\u8a72\u6307\u5357\u4e2d\uff0cFDA\u5efa\u8b70\u5be6\u9a57\u5ba4\u9032\u884c\u4ee5\u4e0b\u64cd\u4f5c\uff1a<\/p>\n<ul>\n<li>\u8a66\u9a57\u9a57\u8b49\u5b8c\u6210\u5f8c\uff0c\u901a\u904e\u96fb\u5b50\u90f5\u4ef6\u901a\u77e5FDA\uff1b<\/li>\n<li>\u63a1\u7528\u5df2\u7372\u5f97EUA\u6388\u6b0a\u7684\u8a66\u9a57\u78ba\u8a8d\u524d5\u500b\u967d\u6027\u548c\u524d5\u500b\u9670\u6027\u6a23\u672c\uff1b<\/li>\n<li>\u5728\u8a66\u9a57\u5831\u544a\u4e2d\u8a3b\u660e\u8a66\u9a57\u5df2\u9a57\u8b49\u4f46FDA\u5c1a\u672a\u5b8c\u6210\u7368\u7acb\u5be9\u67e5\uff1b<\/li>\n<li>\u5728\u5553\u52d5\u6aa2\u6e2c\u5f8c15\u5929\u5167\u63d0\u4ea4EUA\u3002<\/li>\n<\/ul>\n<p>\u6b64\u5916\uff0c\u9084\u6982\u8ff0\u4e86\u5728\u4efb\u4f55\u6a23\u672c\u672a\u901a\u904e\u78ba\u8a8d\u6027\u6aa2\u6e2c\u6216FDA\u7121\u6cd5\u6388\u6b0aEUA\u6642\u61c9\u63a1\u53d6\u7684\u6b65\u9a5f\u3002\u5728\u8a66\u9a57\u9a57\u8b49\u4e2d\uff0c\u5efa\u8b70\u81f3\u5c11\u9032\u884c\u4ee5\u4e0b\u6aa2\u6e2c\uff1a\u6aa2\u51fa\u9650\u5236\uff08LoD\uff09\u3001\u81e8\u5e8a\u8a55\u50f9\u3001\u5305\u5bb9\u6027\u548c\u4ea4\u53c9\u53cd\u61c9\u6027\u3002\u9452\u65bc\u53ef\u7372\u5f97\u7684\u75c5\u6bd2\u6750\u6599\u6709\u9650\uff0cFDA\u3001CDC\u548c\u751f\u7269\u91ab\u5b78\u9ad8\u7d1a\u7814\u7a76\u8207\u958b\u767c\u7ba1\u7406\u5c40\uff08BARDA\uff09\u5c07\u5728\u5be6\u9a57\u5ba4\u505a\u597d\u9a57\u8b49\u6e96\u5099\u6642\u512a\u5148\u4e26\u5354\u8abf\u767c\u8ca8\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong>EUA<\/strong><strong>\u8a66\u9a57\u72c0\u614b<\/strong><\/p>\n<p>CDC\u3001FDA\u548cBARDA\u6b63\u5728\u8207IVD\u751f\u7522\u5546\u548c\u5be6\u9a57\u5ba4\u5408\u4f5c\uff0c\u4ee5\u300c\u5118\u5feb\u300d\u7c3d\u767cEUA\u6388\u6b0a\uff08\u66f4\u65b0\u4fe1\u606f\u898b<a href=\"https:\/\/thelens.clarivate.com\/external-link.jspa?url=https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations%23coronavirus2019\" target=\"_blank\" rel=\"noopener noreferrer\">\u6b64\u8655<\/a>\uff09\u3002\u5230\u76ee\u524d\u70ba\u6b62\uff0c\u6839\u64da\u806f\u90a6\u98df\u54c1\u3001\u85e5\u54c1\u548c\u5316\u599d\u54c1\u6cd5\u6848\uff08FD&amp;C\u6cd5\u6848\uff09\u7b2c564\u7bc0\uff0c\u5df2\u91dd\u5c0d\u4f9b\u7b26\u5408CDC 2019-nCoV\u6aa2\u6e2c\u6a19\u6e96\u7684\u500b\u4eba\u4f7f\u7528\u7684IVD\u7c3d\u767c\u4e86\u5169\u4efdEUA\uff1a<\/p>\n<ol>\n<li>2020\u5e742\u67084\u65e5\uff0cCDC\u7c3d\u767c\u4e862019-\u65b0\u578b\u51a0\u72c0\u75c5\u6bd2\uff082019-nCoV\uff09\u5373\u6642RT-PCR\u8a3a\u65b7\u8a66\u5291\u76d2\u7684EUA\u6388\u6b0a\uff0c\u7528\u65bc\u4e0a\u3001\u4e0b\u547c\u5438\u9053\u6a19\u672c\u4e2d2019-nCoV\u6838\u9178\u7684\u5047\u5b9a\u5b9a\u6027\u6aa2\u6e2c\u3002<\/li>\n<li>2020\u5e742\u670829\u65e5\uff0cFDA\u7c3d\u767c\u4e86\u7d10\u7d04\u5dde\u516c\u5171\u885b\u751f\u90e8\uff08CDC\uff09\u6c83\u8332\u6c83\u65af\u4e2d\u5fc3\u7684\u7d10\u7d04SARS-CoV-2 \u5373\u6642RT-PCR\u8a3a\u65b7\u8a66\u5291\u76d2\u7684EUA\uff0c\u7528\u65bc\u9f3b\u54bd\/\u53e3\u54bd\u62ed\u5b50\u548c\u75f0\u6db2\u4e2dSARS-CoV-2\u6838\u9178\u7684\u5047\u5b9a\u5b9a\u6027\u6aa2\u6e2c\u3002<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p><strong>FDA<\/strong> <strong>COVID-19<\/strong><strong><em>\u9ad4\u5916<\/em><\/strong><strong>\u8a3a\u65b7\u6aa2\u6e2c\u6307\u5357<\/strong><strong>\u7dda\u4e0a<\/strong><strong>\u7814\u8a0e\u6703<\/strong><\/p>\n<p>2020\u5e743\u67082\u65e5\uff0cFDA\u8209\u884c<a href=\"https:\/\/www.fda.gov\/medical-devices\/workshops-conferences-medical-devices\/webinar-policy-diagnostics-testing-laboratories-certified-perform-high-complexity-testing-under-clia\" target=\"_blank\" rel=\"noopener noreferrer\">\u7dda\u4e0a\u7814\u8a0e\u6703<\/a>\uff0c\u7e3d\u7d50\u6700\u65b0\u767c\u5e03\u7684\u6307\u5357\uff0c\u4e26\u70ba\u751f\u7522\u5546\u548c\u7533\u8fa6\u8005\u63d0\u4f9b\u554f\u7b54\uff08Q&amp;A\uff09\u3002\u4ee5\u4e0b\u662fFDA\u5728Q&amp;A\u63d0\u51fa\u7684\u984d\u5916\u5efa\u8b70\uff1a<\/p>\n<ul>\n<li>\u7531\u65bc\u53ef\u7528\u65bc\u6aa2\u6e2c\u7684\u967d\u6027\u6a23\u672c\u6709\u9650\uff0c\u751f\u7522\u5546\u53ef\u4ee5\u5411FDA\u63d0\u4ea4\u96fb\u5b50\u90f5\u4ef6\u7533\u8acb\u3002\u7136\u5f8c\u4ed6\u5011\u6703\u88ab\u6dfb\u52a0\u5230\u9700\u8981\u6750\u6599\u7684\u751f\u7522\u5546\u5217\u8868\u4e2d\u3002\u9084\u6709\u5176\u4ed6\u9a57\u8b49\u9014\u5f91\u3002<\/li>\n<li>\u70ba\u4e86\u52a0\u901f\u5be9\u6279\uff0cFDA\u5efa\u8b70\uff0c\u4e00\u65e6IVD\u8a2d\u5099\u751f\u7522\u5546\u6e96\u5099\u597d\u5b8c\u6574\u7684\u7533\u5831\u8cc7\u6599\u5305\uff0c\u5373\u53ef\u958b\u59cb\u6309\u7167EUA\u524d\u7a0b\u5e8f\u767c\u9001\u90e8\u5206\u7533\u5831\u8cc7\u6599\uff0c\u4ee5\u4fbfFDA\u958b\u59cb\u6efe\u52d5\u5be9\u67e5 [\u524d\u8ff0\u662f\u4f9d\u64da2017\u5e745\u670811\u65e5\u66f4\u65b0\u7684\u6307\u5357\u516c\u544a]\u3002\u5728\u63d0\u4ea4\u7533\u8acb\u7684\u6700\u5f8c\u90e8\u5206\u6642\uff0cFDA\u5c07\u50c5\u8a55\u4f30\u8a72\u90e8\u5206\u3002\u76ee\u524d\u767c\u5e03\u76842\u4efdEUA\u63a1\u7528\u4e86\u8a72\u6d41\u7a0b\uff0c\u5728\u6700\u7d42\u63d0\u4ea4\u5f8c24\u5c0f\u6642\u5167\u7372\u5f97\u6700\u7d42\u6388\u6b0a(final authorization)\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>NIOSH<\/strong><strong>\u6279\u51c6\u7684\u4f9b\u91ab\u52d9\u4eba\u54e1\u4f7f\u7528\u7684\u53e3\u7f69<\/strong><\/p>\n<p>2020\u5e743\u67082\u65e5\uff0cFDA\u767c\u5e03\u4e86\u91ab\u52d9\u4eba\u54e1\u7dca\u6025\u4f7f\u7528\u53e3\u7f69\uff08\u5305\u62ec\u67d0\u4e9bN95\u53e3\u7f69\uff09\u7684EUA\u3002\u9019\u4e9b\u53e3\u7f69\u901a\u5e38\u7528\u65bc\u5de5\u696d\u74b0\u5883\u3002\u7b26\u5408\u8981\u6c42\u7684\u53e3\u7f69\u5305\u62ec\uff1a<\/p>\n<ol>\n<li>\u6240\u6709\u7531\u7f8e\u570b\u8077\u696d\u5b89\u5168\u8207\u5065\u5eb7\u7814\u7a76\u6240\uff08NIOSH\uff09\u6839\u64da42 CFR\u7b2c84\u90e8\u5206 [21 CFR 880] \u6279\u51c6\u70ba\u7121\u52d5\u529b\u7a7a\u6c23\u6de8\u5316\u9846\u7c92\u904e\u6ffe\u53e3\u7f69\uff08filtering facepiece respirators, FFR\uff09\u7684\u4e00\u6b21\u4f7f\u7528\u7684FFR\uff1b\u4ee5\u53ca<\/li>\n<li>\u5df2\u7372\u5f97NIOSH\u6279\u51c6\u3001\u4f46\u5df2\u8d85\u51fa\u88fd\u9020\u5546\u63a8\u85a6\u7684\u91ab\u52d9\u4eba\u54e1\u5728\u91ab\u7642\u74b0\u5883\u4e2d\u4f7f\u7528\u7684\u4fdd\u8cea\u671f\u3001\u53ef\u4ee5\u9632\u6b62\u914d\u6234\u8005\u5728COVID-19\u7206\u767c\u5c0e\u81f4\u7684FFR\u77ed\u7f3a\u671f\u9593\u66b4\u9732\u65bc\u81f4\u75c5\u6027\u751f\u7269\u7a7a\u6c23\u5fae\u7c92\u7684FFR\u3002<\/li>\n<\/ol>\n<p>FDA\u8868\u793a\uff0c\u9019\u4e9bFFR\u7684\u8a2d\u8a08\u76ee\u7684\u662f\u9ad8\u6548\u904e\u6ffe\u7a7a\u6c23\u5fae\u7c92\uff0c\u6bd4\u53e3\u7f69\u904e\u6ffe\u6548\u679c\u66f4\u597d\u3002\u7531\u65bc\u5b83\u5011\u901a\u5e38\u88ab\u7528\u65bc\u5de5\u696d\u74b0\u5883\uff0c\u56e0\u6b64\u7121\u9700\u7b26\u5408FDA\u6aa2\u6e2c\u6a19\u6e96\u3002\u8a72\u63aa\u65bd\u662f\u70ba\u4e86\u61c9\u5c0d\u500b\u4eba\u9632\u8b77\u8a2d\u5099\u8a02\u55ae\u589e\u52a0\u5c0e\u81f4\u91ab\u7642\u4fdd\u5065\u6a5f\u69cb\u77ed\u7f3a\u7684\u5831\u544a\u3002FDA\u8868\u793a\uff0c\u96a8\u8457COVID-19\u7206\u767c\u7684\u6301\u7e8c\uff0c\u5c0d\u9019\u4e9b\u7522\u54c1\u7684\u9700\u6c42\u5c07\u589e\u52a0\uff0c\u9019\u4e9b\u8a2d\u5099\u53ef\u4ee5\u7de9\u89e3\u4f9b\u61c9\u93c8\u53ef\u80fd\u51fa\u73fe\u7684\u77ed\u7f3a\uff1b\u4f46\u662f\uff0c\u516c\u8846\u4e0d\u61c9\u8a72\u4f7f\u7528\u67d0\u4e9bNIOSH\u6279\u51c6\u7684\u53e3\u7f69\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong>COVID-19<\/strong><strong>\u6cbb\u7642<\/strong><\/p>\n<p>\u7f8e\u570b\u570b\u5bb6\u885b\u751f\u7814\u7a76\u9662\uff08NIH\uff09\u570b\u5bb6\u904e\u654f\u548c\u50b3\u67d3\u75c5\u7814\u7a76\u6240\uff08NIAID\uff09\u6b63\u5728\u5967\u99ac\u54c8\u5e02\u5167\u5e03\u62c9\u65af\u52a0\u5927\u5b78\u91ab\u5b78\u4e2d\u5fc3\uff08UNMC\uff09\u7533\u8fa6\u4e00\u9805\u96a8\u6a5f\u3001\u96d9\u76f2\u3001\u5b89\u6170\u5291\u5c0d\u7167\u2161\u671f\u7814\u7a76\uff0c\u4ee5\u78ba\u5b9a\u65b0\u578b\u6cbb\u7642\u85e5\u7269\uff08\u5305\u62ec\u8a66\u9a57\u6027\u65b0\u85e5\uff08IND\uff09remdesivir\uff09\u5728\u78ba\u8a3a\u70baCOVID-19\u7684\u4f4f\u9662\u6210\u4eba\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n<p>\u8a72\u7814\u7a76\u6b63\u5728\u62db\u52df394\u4f8b\u5e74\u9f61\u226518\u6b72\u7684\u60a3\u8005\uff0c\u5167\u5bb9\u5305\u62ec\u4e0d\u540c\u8a66\u9a57\u6027\u6cbb\u7642\u85e5\u7269\u8207\u5b89\u6170\u5291\u4e4b\u9593\u7684\u4e00\u7cfb\u5217\u7d44\u9593\u6bd4\u8f03\uff0c\u540c\u6642\u958b\u5c55\u4e2d\u671f\u76e3\u6e2c\u4ee5\u6dfb\u52a0\u65b0\u7d44\uff0c\u4e26\u5141\u8a31\u53d7\u8a66\u8005\u56e0\u7121\u6548\u3001\u7642\u6548\u6216\u5b89\u5168\u6027\u554f\u984c\u800c\u63d0\u524d\u7d42\u6b62\u3002\u4e3b\u8981\u7d50\u5c40\u6307\u6a19\u662f\u5728\u7b2c15\u5929\u524d\u5831\u544a7\u5206\u8a55\u91cf\u91cf\u8868\u4e0a\u6bcf\u7a2e\u56b4\u91cd\u7a0b\u5ea6\u7684\u53d7\u8a66\u8005\u767e\u5206\u6bd4\u3002<\/p>\n<p>\u300c\u7f8e\u570b\u570b\u5bb6\u904e\u654f\u548c\u50b3\u67d3\u75c5\u7814\u7a76\u6240\uff08NIAID\uff09\u6b63\u5728\u7533\u8fa6\u4e00\u9805\u96a8\u6a5f\u3001\u96d9\u76f2\u3001\u5b89\u6170\u5291\u5c0d\u7167\u2161\u671f\u8a66\u9a57\uff0c\u4ee5\u78ba\u5b9a\u65b0\u578b\u6cbb\u7642\u85e5\u7269\uff08\u5305\u62ec\u8a66\u9a57\u6027\u65b0\u85e5\uff08IND\uff09remdesivir\uff09\u5728\u78ba\u8a3a\u70baCOVID-19\u7684\u4f4f\u9662\u6210\u4eba\u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u300d<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u75ab\u82d7<\/strong><\/p>\n<p>\u6839\u64da\u8a66\u9a57\u7533\u8acb\u8005\u7684\u5831\u544a\uff0cCodagenix,Inc\u6b63\u5728\u8207\u5370\u5ea6\u8840\u6e05\u7814\u7a76\u6240\u5408\u4f5c\uff0c\u7814\u7a76\u4e00\u7a2e\u6e1b\u6bd2\u6d3b\u75ab\u82d7\uff0c\u7528\u65bc\u9810\u9632\u7531SARS-CoV-2 2019-nCoV\u75c5\u6bd2\u682a\u5f15\u8d77\u7684COVID-19\u3002\u622a\u81f32020\u5e742\u6708\uff0c\u5df2\u8a2d\u8a08\u4e86\u591a\u7a2enCoV\u5019\u9078\u75ab\u82d7\u57fa\u56e0\u7d44\uff0c\u8a66\u9a57\u7533\u8acb\u8005\u8a08\u5283\u5728\u81e8\u5e8a\u8a66\u9a57\u524d\u9032\u884c\u75ab\u82d7\u75c5\u6bd2<em>\u9ad4\u5167<\/em>\u57f9\u990a\u548c\u8a55\u50f9\u3002<\/p>\n<p>Novavax,Inc.\u6b63\u5728\u958b\u767c\u4e00\u7a2e\u65b0\u578b\u75ab\u82d7\uff0c\u7528\u4ee5\u9810\u9632COVID-19\u3002\u8a66\u9a57\u7533\u8acb\u8005\u5df2\u7d93\u751f\u7522\u591a\u7a2e\u5948\u7c73\u9846\u7c92\u5019\u9078\u75ab\u82d7\uff0c\u6b63\u5728\u52d5\u7269\u6a21\u578b\u4e2d\u8a55\u4f30\uff0c\u7136\u5f8c\u78ba\u5b9a\u7528\u65bc\u4eba\u9ad4\u8a66\u9a57\uff08\u9810\u8a082020\u5e74\u6625\u672b\u958b\u59cb\uff09\u7684\u6700\u4f73\u5019\u9078\u75ab\u82d7\u3002\u6839\u64da\u516c\u53f8\u5831\u544a\uff0c\u6191\u85c9\u5728MERS\u548cSARS\u65b9\u9762\u7684\u7d93\u9a57\uff0cNovavax\u80fd\u5920\u5feb\u901f\u61c9\u5c0dCOVID-19\u3002\u7533\u8fa6\u8005\u7684COVID-19\u5019\u9078\u75ab\u82d7\u662f\u4f7f\u7528\u5176\u5c08\u6709\u7684\u91cd\u7d44\u86cb\u767d\u7d0d\u7c73\u9846\u7c92\u6280\u8853\u5e73\u53f0\u88fd\u9020\u7684\uff0c\u4ee5\u7522\u751f\u4f86\u81ea\u51a0\u72c0\u75c5\u6bd2\u523a\u7a81\u86cb\u767d\u7684\u6297\u539f\u3002Novavax\u8a08\u5283\u4f7f\u7528\u5176\u5c08\u6709\u7684Matrix-M\u4f50\u5291\u53ca\u5176COVID-19\u5019\u9078\u75ab\u82d7\u589e\u5f3a\u514d\u75ab\u53cd\u61c9\u3002\u2160\u671f\u81e8\u5e8a\u8a66\u9a57\u7684\u9810\u671f\u958b\u59cb\u65e5\u671f\u70ba2020\u5e745\u6708\u62166\u6708\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><span class=\"cp-load-after-post\"><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>SARS-CoV2\u7684\u6301\u7e8c\u50b3\u64ad\u5c0e\u81f4\u60a3\u8005\u51fa\u73fe\u56b4\u91cd\u7279\u6b8a\u50b3\u67d3\u6027\u80ba\u708e\uff08COVID-19\uff09\uff0c\u6211\u5011\u6aa2\u8996\u4e86FDA\u95dc\u65bc\u9ad4\u5916\u8a3a\u65b7\u6aa2\u6e2c\u548c\u53e3\u7f69\u5728\u91ab\u7642\u74b0\u5883\u4e2d\u4f7f\u7528\u7684\u6307\u5357\uff0c\u91cd\u9ede\u8a0e\u8ad6\u4e86\u7576\u524d\u7684\u6cbb\u7642\u548c\u75ab\u82d7\u8a66\u9a57\u3002 &nbsp; \u672c\u6587\u4f5c\u8005\uff1aJaime Polychrones\uff0c\u79d1\u777f\u552f\u5b89 Cortellis Regulatory Intelligence \u91ab\u5b78\u4f5c\u8005\uff08\u82f1\u6587\u539f\u6587\u767c\u4f48\u65e5\u671f\uff1a2020\u5e743\u670811\u65e5\uff09 &nbsp; 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